Ablation of Atrial FibrillationEarly Phase 1AFNCT01298986
Atrial Fibrillation Ablation The Hybrid Approach Versus Traditional Management
A Early Phase 1 study testing Pulmonary vein isolation ablation procedure for atrial fibrillation, Hybrid procedure for ablation of atrial fibrillation and The Cox Maze Procedure for Ablation of Atrial Fibrillation in people with Ablation of Atrial Fibrillation, run by Inova Health Care Services.
Trial summary
Rationale: To determine the most beneficial ablation methodology for individual patients with paroxysmal or persistent atrial fibrillation (defined by the Heart Rhythm Society) as surgeons and electrophysiologists work together on a convergent procedure (hybrid) to place the epicardial and endocardial ablation lines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ablation of Atrial Fibrillation
- What is being tested?
- Pulmonary vein isolation ablation procedure for atrial fibrillation, Hybrid procedure for ablation of atrial fibrillation and The Cox Maze Procedure for Ablation of Atrial Fibrillation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Sep 2014
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be included if they present for ablation with paroxysmal or persistent atrial fibrillation as defined by the Heart Rhythm Society and their left atrium is < 6.1 cm (volume)
- Patients must be symptomatic with their AF as noted by their inability to perform their daily activities due to shortness of breath, fatigue, palpitations or other debilitating symptoms
- Paroxysmal atrial fibrillation is defined as atrial fibrillation that resolves on its own within 7 days of onset
- Persistent atrial fibrillation is defined as atrial fibrillation that does not resolve on its own and requires medical intervention to include medication therapy and/or electric cardioversion
Who cannot join
- Patients will be excluded if they present with long standing persistent atrial fibrillation as defined by the Heart Rhythm Society
- All patients with MV +2 mitral regurgitation will be excluded
- Require other cardiac surgery procedures will be excluded
- Are unable to take anticoagulation
- Are unable to take any prescribed anti arrhythmic medication
- Have a left atrium measuring greater than 6.0 cm (volume)
Show all 11Show fewer
- Have had previous catheter ablation for atrial fibrillation
- Have had previous pace maker implantation
- Are less than 18 years of age
- Do not speak English and no translation can be provided
- Are unable or unwilling to be followed according to set protocol to include obtaining an internally heart monitor 6 weeks prior to their ablation procedure
About this study
Rationale: To determine the most beneficial ablation methodology for individual patients with paroxysmal or persistent atrial fibrillation (defined by the Heart Rhythm Society) as surgeons and electrophysiologists work together on a convergent procedure (hybrid) to place the epicardial and endocardial ablation lines.
Objectives: Catheter and surgical ablation are being offered today to patients with drug refractory and symptomatic atrial fibrillation. This study is designed to assess the most efficient ablation approach in patients with paroxysmal and persistent atrial fibrillation. In patients with left atrium size of less than 5.0 cm, a Hybrid approach (pulmonary vein isolation performed surgically will be combined with right and left atrial flutter lines performed using a transcatheter approach) will be compared to percutaneous catheter ablation to isolate the pulmonary veins and apply the left and right atrial flutter lines with removal of LA appendage. In the group of patients with left atrial size 5.0-6.0 cm the Hybrid approach is going to be compared to the minimally invasive Cox-Maze III procedure.
Read more
Our hypotheses with regard to the rate of return to sinus rhythm off antiarrhythmic drugs at 6 months will demonstrate that the Hybrid approach is going to be a: superior to percutaneous catheter ablation in the less than 5 cm left atrial group and b: non-inferior when compared to the Cox-Maze III procedure in the 5-6 cm left atrial cm group.
We hypothesize that the safety of all procedures will show no differences and that there will be no differences in clinical complications between groups.
Read the detailed description
Study Type: This is an experimental study in which patients who present with either paroxysmal or persistent atrial fibrillation will be randomized based on their left atrial size (≤ 5.0 or > 5.0 but < 6.1 cm) to receive a hybrid ablation approach vs percutaneous catheter where in both procedures ablation will include pulmonary vein isolation with a left and right atrial flutter line for patients with a left atrium ≤ 5.0 cm. and hybrid approach will be compared to the Cox Maze III procedure for patients with a left atrium > 5.0 < 6.1 cm .
Study Design: One hundred and fifty two patients (n=152) with persistent or paroxysmal atrial fibrillation who present for surgical or catheter ablation intervention are to be enrolled. The study will take place at the Inova Heart and Vascular Institute in Falls Church, VA in the specially designed hybrid surgical suite in the cardiovascular operating area. We expect enrollment to take (two years study duration). Patients will be included if they present for ablation with paroxysmal or persistent atrial fibrillation as defined by the Heart Rhythm Society and their left atrium is < 6.1 cm (volume). Patients will be excluded if they present with long standing persistent atrial fibrillation as defined by the Heart Rhythm Society, require other cardiac surgery, are unable to take anticoagulation or require prescribed anti arrhythmic medication for reason other than atrial fibrillation, have a left atrium measuring greater than 6.0 cm (volume),have had previous catheter ablation for atrial fibrillation (Do not exclude for prior AVNRT) or a pacemaker, are less than 18 years of age, are unable or unwilling to be followed according to set protocol to include implantation of a heart monitor 6 weeks prior to their ablation procedure.
Study Methodology: This is an experimental study in which patients who present with either paroxysmal or persistent atrial fibrillation will be randomized based on their left atrial size.
For patients with a left atrium size of less than 5.0 cm, a Hybrid approach (pulmonary vein isolation performed surgically will be combined with right and left atrial flutter lines performed using a transcatheter approach) will be compared to percutaneous catheter ablation to isolate the pulmonary veins and apply the left and right atrial flutter lines. In the group of patients with left atrial size of 5.0-6.0 cm the Hybrid approach is going to be compared to the minimally invasive Cox-Maze III procedure (Figure 1). Each patient regardless of procedure will have their left atrial appendage closed. All patients will receive an internal event monitor (Reveal XT) which will be placed 6 weeks before their procedure to establish atrial fibrillation burden. All patients will also be given a health related quality of life and a symptom frequency and severity tool to fill out prior to their ablation and at 3 and 6 months post ablation.
The primary outcome will be the rate of return to sinus rhythm as defined by the Heart Rhythm Society Guidelines (sinus rhythm maintained off anti arrhythmic medications and any monitored atrial arrhythmia greater than 30 seconds will be considered a recurrence) at 6 months and atrial fibrillation burden
The secondary outcomes will include:
Number and type of procedural complications Number of embolic strokes The number of major bleeding events as defined by the need to receive a transfusion for the amount of blood lost and or hemorrhagic stroke while receiving anticoagulation therapy.
Reported improvement in patients' self reported health related quality of life and their symptom frequency and severity at 3 and 6 months
Statistical Methodology: Since this is a proof of concept study without any prior literature to obtain margins, we used the current rate of return to sinus rhythm as our margins to determine sample size. This is fully explained in section 4.2. Based on these calculations, 152 patients will be randomized as described above. Descriptive statistics will be used to characterize the patient population. T-tests and ANOVAs will be used to look for differences between groups within the continuous data. Chi square, Fisher's Exact test and/or McNemar's Test will be used to look for differences among categorical variables. For all analyses, a two-sided p value <0.05 will be used to determine significance.
To analyze the primary objective, the percentage of patients in each group who return to normal sinus rhythm will be calculated. Chi square analysis, or logistic regression if covariates are required, will be used to test for differences in the odds of returning to normal sinus rhythm between the treatment groups in both arms of the study. Chi square and/or logistic regression will also be used to assess the secondary aim regarding complications between the treatment groups. For the left atrial size > 5.0 but < 6.1 cm arm of the study, testing for non-inferiority of complication rates will be conducted using the treatment effect and 95% confidence intervals. These will be compared against the 10% non-inferiority margins, to assess whether the treatment effect and 95% confidence interval fall entirely within the margins. Lastly, repeated measures analysis of variance (ANOVA) will be conducted to examine the secondary aim regarding change in health-related quality of life by treatment groups.
- Conditions
- Ablation of Atrial Fibrillation
- Being tested
- Pulmonary vein isolation ablation procedure for atrial fibrillation, Hybrid procedure for ablation of atrial fibrillation, The Cox Maze Procedure for Ablation of Atrial Fibrillation, Hybrid Procedure for Left Atrium >5 cm but < 6.1 cm
- Keywords
- atrial fibrillation ablation procedures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary vein isolation ablation procedure for atrial fibrillationProcedure or surgery
The catheters will be introduced to the right atrium using the femoral vein as an access. Following a trans-septal puncture, ablation catheters will be placed in the left atrium under appropriate imaging and anticoagulation conditions (Standard of care). Following the positioning of the ablation catheters in the left heart cavity ablation to achieve PVI and left atrial isthmus line are going to be performed. Following the appropriate protocol of mapping and AF induction the right sided isthmus is going to be ablated to achieve a flutter line ablation as well. Following the procedure and following the appropriate standard of care protocols, the catheter are going to be retrieved and the procedure will be concluded. The left atrial appendage will be managed surgically. All ablation lines will be placed according to their current standard of practice using radiofrequency ablation technology and based on CARTO mapping.
Hybrid procedure for ablation of atrial fibrillationProcedure or surgery
The endoscope will be passed though a small port in the right thoracic cavity to the beating heart. The pericardium will be opened, the coronary sinus transected. The ablation catheters will pass underneath the SVC and IVC establishing access to the transverse and oblique sinuses. A box lesion will be epicardially placed around the pulmonary veins using cryothermia. An additional lesion line will be placed from the box lesion to the left atrial appendage. The ablation catheter will be left in place to guide the EP physicians in placing the right and left atrial flutter lines using radiofrequency. Electromagnetic mapping using a CARTO system and measuring for conduction block of the pulmonary veins will be conducted by the EP's. A second small port will then placed in the left thoracic cavity and the pericardium on the left side will be opened and the left atrial appendage will be ablated with the use of a clip placed around the left atrial appendage and tightened.
The Cox Maze Procedure for Ablation of Atrial FibrillationProcedure or surgery
A 7-cm incision is placed and the chest is entered through the 4th or 5th intercostal space. The femoral artery and femoral vein are cannulated. The pericardium is opened. Cardiopulmonary bypass is instituted. The right sided lesions are applied using 3 purse-strings that are placed over the right atrial free wall. The right and left atrial lesions are done using cryoablation using either nitrous oxide or Argon. Next the left atrium is entered through a standard atriotomy placed in the interatrial groove. The base of the left atrial appendage is cryoablated and connected to the left upper pulmonary vein. All four pulmonary veins are then encircled using multiple application of cryo. An endocardial cryolesion is then placed posteriorly down to the level of the mid-mitral valve annulus and an epicardial cryolesion is placed on the coronary sinus directly across the atrial wall from the endocardial lesion. The left atrial appendage is then surgically managed.
Hybrid Procedure for Left Atrium >5 cm but < 6.1 cmProcedure or surgery
The endoscope will be passed though a small port in the right thoracic cavity to the beating heart. The pericardium will be opened, the coronary sinus transected. The ablation catheters will pass underneath the SVC and IVC establishing access to the transverse and oblique sinuses. A box lesion will be epicardially placed around the pulmonary veins using cryothermia. An additional lesion line will be placed from the box lesion to the left atrial appendage. The ablation catheter will be left in place to guide the EP physicians in placing the right and left atrial flutter lines using radiofrequency. Electromagnetic mapping using a CARTO system and measuring for conduction block of the pulmonary veins will be conducted by the EP's. A second small port will then placed in the left thoracic cavity and the pericardium on the left side will be opened and the left atrial appendage will be ablated with the use of a clip placed around the left atrial appendage and tightened.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Vein Isolation | Active comparator | Patients who have paroxysmal or persistent atrial fibrillation but whose left atrium is < /= 5.0 Receives: Procedure: Pulmonary vein isolation ablation procedure for atrial fibrillation |
| Hybrid procedure for patients with a left atrium < /= 5.0 cm | Experimental | A combined procedure where the cardiac surgeon will place the ablation lesions on top of the heart and the electrophysiologist will place the lesions inside the heart. 3D mapping with be used to guide the procedure. The left atrial appendage will be surgically managed. Receives: Procedure: Hybrid procedure for ablation of atrial fibrillation |
| Cox Maze Procedure | Active comparator | All lesions of the Cox Maze procedure will be completed as originally described by Dr. James Cox using crypthermia. Patients will be randomized if there left atrium is >5.0 cm but < 6.1 cm and are experiencing paroxysmal or persistent atrial fibrillation Receives: Procedure: The Cox Maze Procedure for Ablation of Atrial Fibrillation |
| Hybrid Procedure | Experimental | A collaborative approach between electrophysiologist and surgeons for patients with a left atrium <5.0 cm and < 6.1 cm where the surgeon will epicardially place the ablation lesions and the electrophysiologist will place the lesion lines endocardially. 3D mapping will be used and the left atrial appendage will be surgically managed. Receives: Procedure: Hybrid Procedure for Left Atrium >5 cm but < 6.1 cm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to sinus rhythm rate
The primary outcome will be the rate of return to sinus rhythm as defined by the Heart Rhythm Society Guidelines (sinus rhythm maintained off anti arrhythmic medications and any monitored atrial arrhythmia greater than 30 seconds will be considered a recurrence) at 6 months.
Measured: 2-3 years
Secondary outcomes (1)
Post procedure morbidities
The secondary outcomes will include:
Total AF burden Number and type of procedural complications Number of embolic strokes The number of major bleeding as defined by the need to receive a transfusion for the amount of blood lost and or hemorrhagic stroke while receiving anticoagulation therapy.
Reported improvement in patients' self reported health related quality of life and their symptom frequency and severity at 3 and 6 months
Measured: up to 6 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startMay 2011
- Primary completionSep 2014
- Study completionSep 2014
Why it stopped: No subjects were ever enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ablation of Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Niv Ad, MD, Principal investigator, Inova Fairfax Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298986
- Sponsor's protocol ID
- 10.126 Hybrid AF
- Acronym
- AF
- Status last verified
- Mar 2015
- First submitted
- 16 Feb 2011
- Last updated
- 27 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation Ablation The Hybrid Approach Versus Traditional Management
- ClinicalTrials.gov ID
- NCT01298986
- Acronym / sponsor ID
- AF / 10.126 Hybrid AF
- Conditions
- Ablation of Atrial Fibrillation
- Keywords
- atrial fibrillation ablation procedures
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No subjects were ever enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 18 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: To determine the most beneficial ablation methodology for individual patients with paroxysmal or persistent atrial fibrillation (defined by the Heart Rhythm Society) as surgeons and electrophysiologists work together on a convergent procedure (hybrid) to place the epicardial and endocardial ablation lines.
Objectives: Catheter and surgical ablation are being offered today to patients with drug refractory and symptomatic atrial fibrillation. This study is designed to assess the most efficient ablation approach in patients with paroxysmal and persistent atrial fibrillation. In patients with left atrium size of less than 5.0 cm, a Hybrid approach (pulmonary vein isolation performed surgically will be combined with right and left atrial flutter lines performed using a transcatheter approach) will be compared to percutaneous catheter ablation to isolate the pulmonary veins and apply the left and right atrial flutter lines with removal of LA appendage. In the group of patients with left atrial size 5.0-6.0 cm the Hybrid approach is going to be compared to the minimally invasive Cox-Maze III procedure.
Our hypotheses with regard to the rate of return to sinus rhythm off antiarrhythmic drugs at 6 months will demonstrate that the Hybrid approach is going to be a: superior to percutaneous catheter ablation in the less than 5 cm left atrial group and b: non-inferior when compared to the Cox-Maze III procedure in the 5-6 cm left atrial cm group.
We hypothesize that the safety of all procedures will show no differences and that there will be no differences in clinical complications between groups.
Detailed description
Study Type: This is an experimental study in which patients who present with either paroxysmal or persistent atrial fibrillation will be randomized based on their left atrial size (≤ 5.0 or > 5.0 but < 6.1 cm) to receive a hybrid ablation approach vs percutaneous catheter where in both procedures ablation will include pulmonary vein isolation with a left and right atrial flutter line for patients with a left atrium ≤ 5.0 cm. and hybrid approach will be compared to the Cox Maze III procedure for patients with a left atrium > 5.0 < 6.1 cm .
Study Design: One hundred and fifty two patients (n=152) with persistent or paroxysmal atrial fibrillation who present for surgical or catheter ablation intervention are to be enrolled. The study will take place at the Inova Heart and Vascular Institute in Falls Church, VA in the specially designed hybrid surgical suite in the cardiovascular operating area. We expect enrollment to take (two years study duration). Patients will be included if they present for ablation with paroxysmal or persistent atrial fibrillation as defined by the Heart Rhythm Society and their left atrium is < 6.1 cm (volume). Patients will be excluded if they present with long standing persistent atrial fibrillation as defined by the Heart Rhythm Society, require other cardiac surgery, are unable to take anticoagulation or require prescribed anti arrhythmic medication for reason other than atrial fibrillation, have a left atrium measuring greater than 6.0 cm (volume),have had previous catheter ablation for atrial fibrillation (Do not exclude for prior AVNRT) or a pacemaker, are less than 18 years of age, are unable or unwilling to be followed according to set protocol to include implantation of a heart monitor 6 weeks prior to their ablation procedure.
Study Methodology: This is an experimental study in which patients who present with either paroxysmal or persistent atrial fibrillation will be randomized based on their left atrial size.
For patients with a left atrium size of less than 5.0 cm, a Hybrid approach (pulmonary vein isolation performed surgically will be combined with right and left atrial flutter lines performed using a transcatheter approach) will be compared to percutaneous catheter ablation to isolate the pulmonary veins and apply the left and right atrial flutter lines. In the group of patients with left atrial size of 5.0-6.0 cm the Hybrid approach is going to be compared to the minimally invasive Cox-Maze III procedure (Figure 1). Each patient regardless of procedure will have their left atrial appendage closed. All patients will receive an internal event monitor (Reveal XT) which will be placed 6 weeks before their procedure to establish atrial fibrillation burden. All patients will also be given a health related quality of life and a symptom frequency and severity tool to fill out prior to their ablation and at 3 and 6 months post ablation.
The primary outcome will be the rate of return to sinus rhythm as defined by the Heart Rhythm Society Guidelines (sinus rhythm maintained off anti arrhythmic medications and any monitored atrial arrhythmia greater than 30 seconds will be considered a recurrence) at 6 months and atrial fibrillation burden
The secondary outcomes will include:
Number and type of procedural complications Number of embolic strokes The number of major bleeding events as defined by the need to receive a transfusion for the amount of blood lost and or hemorrhagic stroke while receiving anticoagulation therapy.
Reported improvement in patients' self reported health related quality of life and their symptom frequency and severity at 3 and 6 months
Statistical Methodology: Since this is a proof of concept study without any prior literature to obtain margins, we used the current rate of return to sinus rhythm as our margins to determine sample size. This is fully explained in section 4.2. Based on these calculations, 152 patients will be randomized as described above. Descriptive statistics will be used to characterize the patient population. T-tests and ANOVAs will be used to look for differences between groups within the continuous data. Chi square, Fisher's Exact test and/or McNemar's Test will be used to look for differences among categorical variables. For all analyses, a two-sided p value <0.05 will be used to determine significance.
To analyze the primary objective, the percentage of patients in each group who return to normal sinus rhythm will be calculated. Chi square analysis, or logistic regression if covariates are required, will be used to test for differences in the odds of returning to normal sinus rhythm between the treatment groups in both arms of the study. Chi square and/or logistic regression will also be used to assess the secondary aim regarding complications between the treatment groups. For the left atrial size > 5.0 but < 6.1 cm arm of the study, testing for non-inferiority of complication rates will be conducted using the treatment effect and 95% confidence intervals. These will be compared against the 10% non-inferiority margins, to assess whether the treatment effect and 95% confidence interval fall entirely within the margins. Lastly, repeated measures analysis of variance (ANOVA) will be conducted to examine the secondary aim regarding change in health-related quality of life by treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Vein Isolation | Active comparator | Procedure: Pulmonary vein isolation ablation procedure for atrial fibrillationPatients who have paroxysmal or persistent atrial fibrillation but whose left atrium is < /= 5.0 |
| Hybrid procedure for patients with a left atrium < /= 5.0 cm | Experimental | Procedure: Hybrid procedure for ablation of atrial fibrillationA combined procedure where the cardiac surgeon will place the ablation lesions on top of the heart and the electrophysiologist will place the lesions inside the heart. 3D mapping with be used to guide the procedure. The left atrial appendage will be surgically managed. |
| Cox Maze Procedure | Active comparator | Procedure: The Cox Maze Procedure for Ablation of Atrial FibrillationAll lesions of the Cox Maze procedure will be completed as originally described by Dr. James Cox using crypthermia. Patients will be randomized if there left atrium is >5.0 cm but < 6.1 cm and are experiencing paroxysmal or persistent atrial fibrillation |
| Hybrid Procedure | Experimental | Procedure: Hybrid Procedure for Left Atrium >5 cm but < 6.1 cmA collaborative approach between electrophysiologist and surgeons for patients with a left atrium <5.0 cm and < 6.1 cm where the surgeon will epicardially place the ablation lesions and the electrophysiologist will place the lesion lines endocardially. 3D mapping will be used and the left atrial appendage will be surgically managed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients will be included if they present for ablation with paroxysmal or persistent atrial fibrillation as defined by the Heart Rhythm Society and their left atrium is < 6.1 cm (volume)
- Patients must be symptomatic with their AF as noted by their inability to perform their daily activities due to shortness of breath, fatigue, palpitations or other debilitating symptoms
- Paroxysmal atrial fibrillation is defined as atrial fibrillation that resolves on its own within 7 days of onset
- Persistent atrial fibrillation is defined as atrial fibrillation that does not resolve on its own and requires medical intervention to include medication therapy and/or electric cardioversion
Key exclusion criteria (11 listed)
- Patients will be excluded if they present with long standing persistent atrial fibrillation as defined by the Heart Rhythm Society
- All patients with MV +2 mitral regurgitation will be excluded
- Require other cardiac surgery procedures will be excluded
- Are unable to take anticoagulation
- Are unable to take any prescribed anti arrhythmic medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary vein isolation ablation procedure for atrial fibrillationThe catheters will be introduced to the right atrium using the femoral vein as an access. Following a trans-septal puncture, ablation catheters will be placed in the left atrium under appropriate imaging and anticoagulation conditions (Standard of care). Following the positioning of the ablation catheters in the left heart cavity ablation to achieve PVI and left atrial isthmus line are going to be performed. Following the appropriate protocol of mapping and AF induction the right sided isthmus is going to be ablated to achieve a flutter line ablation as well. Following the procedure and following the appropriate standard of care protocols, the catheter are going to be retrieved and the procedure will be concluded. The left atrial appendage will be managed surgically. All ablation lines will be placed according to their current standard of practice using radiofrequency ablation technology and based on CARTO mapping. | Procedure or surgery | Pulmonary Vein Isolation |
| Hybrid procedure for ablation of atrial fibrillationThe endoscope will be passed though a small port in the right thoracic cavity to the beating heart. The pericardium will be opened, the coronary sinus transected. The ablation catheters will pass underneath the SVC and IVC establishing access to the transverse and oblique sinuses. A box lesion will be epicardially placed around the pulmonary veins using cryothermia. An additional lesion line will be placed from the box lesion to the left atrial appendage. The ablation catheter will be left in place to guide the EP physicians in placing the right and left atrial flutter lines using radiofrequency. Electromagnetic mapping using a CARTO system and measuring for conduction block of the pulmonary veins will be conducted by the EP's. A second small port will then placed in the left thoracic cavity and the pericardium on the left side will be opened and the left atrial appendage will be ablated with the use of a clip placed around the left atrial appendage and tightened. | Procedure or surgery | Hybrid procedure for patients with a left atrium < /= 5.0 cm |
| The Cox Maze Procedure for Ablation of Atrial FibrillationA 7-cm incision is placed and the chest is entered through the 4th or 5th intercostal space. The femoral artery and femoral vein are cannulated. The pericardium is opened. Cardiopulmonary bypass is instituted. The right sided lesions are applied using 3 purse-strings that are placed over the right atrial free wall. The right and left atrial lesions are done using cryoablation using either nitrous oxide or Argon. Next the left atrium is entered through a standard atriotomy placed in the interatrial groove. The base of the left atrial appendage is cryoablated and connected to the left upper pulmonary vein. All four pulmonary veins are then encircled using multiple application of cryo. An endocardial cryolesion is then placed posteriorly down to the level of the mid-mitral valve annulus and an epicardial cryolesion is placed on the coronary sinus directly across the atrial wall from the endocardial lesion. The left atrial appendage is then surgically managed. | Procedure or surgery | Cox Maze Procedure |
| Hybrid Procedure for Left Atrium >5 cm but < 6.1 cmThe endoscope will be passed though a small port in the right thoracic cavity to the beating heart. The pericardium will be opened, the coronary sinus transected. The ablation catheters will pass underneath the SVC and IVC establishing access to the transverse and oblique sinuses. A box lesion will be epicardially placed around the pulmonary veins using cryothermia. An additional lesion line will be placed from the box lesion to the left atrial appendage. The ablation catheter will be left in place to guide the EP physicians in placing the right and left atrial flutter lines using radiofrequency. Electromagnetic mapping using a CARTO system and measuring for conduction block of the pulmonary veins will be conducted by the EP's. A second small port will then placed in the left thoracic cavity and the pericardium on the left side will be opened and the left atrial appendage will be ablated with the use of a clip placed around the left atrial appendage and tightened. | Procedure or surgery | Hybrid Procedure |
Primary outcome
Return to sinus rhythm rate
Time frame: 2-3 years
The primary outcome will be the rate of return to sinus rhythm as defined by the Heart Rhythm Society Guidelines (sinus rhythm maintained off anti arrhythmic medications and any monitored atrial arrhythmia greater than 30 seconds will be considered a recurrence) at 6 months.
1 secondary outcome
Post procedure morbidities
Time frame: up to 6 months post procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niv Ad, MD principal investigator
Inova Fairfax Hospital
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pulmonary vein isolation ablation procedure for atrial fibrillation, Hybrid procedure for ablation of atrial fibrillation and The Cox Maze Procedure for Ablation of Atrial Fibrillation in people with Ablation of Atrial Fibrillation, run by Inova Health Care Services.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return to sinus rhythm rate (time frame: 2-3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2015.