Persistent Atrial FibrillationNCT02344394
Comparison of Hybrid Ablation and Pulmonary Vein Isolation Alone vs Hybrid Ablation With PVI Plus Catheter Ablation
A study testing Medtronic Cryoballoon, Thermocool Catheter and nContact in people with Persistent Atrial Fibrillation, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The overall objective of the study is to compare and assess the clinical outcomes of the standard of care hybrid ablation using epicardial ablation in conjunction with endocardial PVI alone versus epicardial ablation in conjunction with endocardial ablation using PVI with additional RF ablation in a randomized… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Medtronic Cryoballoon, Thermocool Catheter and nContact
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 13 Dec 2017
- Phase
- Interventional
- 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
- The subject is 18 years of age or older
- Left atrium < 6.0 em (Trans Thoracic Echo - TTE- parasternal4 chamber view performed within 6 months)
- History of AF for at least 6 months
- Failed or refractory to one AAD (class I and/or Ill)
- Documentation of persistent AF
- Provided written informed consent
- Be eligible for the hybrid procedure
Who cannot join
- Pregnant or planning to become pregnant during study
- Co-morbid medical conditions that limit one year life expectancy
- Previous cardiac surgery
- Previous abdominal surgery which will prevent epicardial access
- History of pericarditis
- Previous cerebrovascular accident (CVA), excluding fully resolved TIA
Show all 14Show fewer
- Patients who have active infection or sepsis
- Patients with esophageal ulcers strictures and varices
- Patients with renal dysfunction who are not on dialysis (defined as GFR ::5 40)
- Patients who are contraindicated for anticoagulants such as heparin and coumadin
- Patients who are being treated for ventricular arrhythmias
- Patients who have had a previous left atrial catheter ablation for AF (does not include ablation for AFL or other supraventricular arrhythmias)
- Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment
- Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative)
Trial locations and contacts
1 site in 1 country.
United States1 site
Aurora Health Care, St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
About this study
Official title: Prospective, Randomized Comparison of Hybrid Ablation and Pulmonary Vein Isolation Alone Versus Hybrid Ablation With Pulmonary Vein Isolation Plus Catheter Ablation for CFAE and Linear Lesions
The overall objective of the study is to compare and assess the clinical outcomes of the standard of care hybrid ablation using epicardial ablation in conjunction with endocardial PVI alone versus epicardial ablation in conjunction with endocardial ablation using PVI with additional RF ablation in a randomized, prospective population of patients with persistent AF of at least 6 months duration. All devices that are used are being utilized under the approved labeling of the devices.
Read the detailed description
Atrial fibrillation (AF) is one of the leading causes of stroke and heart failure. It is also a major cause of hospitalizations and mortality (Stewart, Wattigney, and Wolf). Patients with atrial fibrillation (AF) who are intolerant to Class I and III antiarrhythmic drugs often require endocardial ablation, which can include pulmonary vein isolation (PVI) using radiofrequency (RF) catheter ablation or cryoballoon ablation (Medtronic, MN) and reported success rates vary (Calkins et al). In patients with persistent and long standing persistent AF success rates may not be as high (Akoum et al) and there is little data analyzing outcomes for patients in this population (Calkins et al). Using an epicardial-endocardial, or hybrid, approach Gehi et al describes a 66% 12 month arrythmia-free survival rate following the procedure, with 37% patients still on antiarrythmic drug therapy at 12 months. Furthermore, a paper by Anderson et al reports that the hybrid ablation results in lower costs and higher quality adjusted life years for patients with non-paroxysmal AF as reported by the studie's results of fewer repeat ablations and maintenance of sinus rhythm at 5 years. Conflicting reports exist on how much endocardial catheter ablation is needed for patients in persistent and long standing persistent AF. Verma et al reports results for patients in persistent AF having endocardial PVI compared to P VI plus additional linear lesions. Eighteen month success rates for these patients were 59% and 46% respectively.
Success of surgical hybrid ablation using epicardial ablation cocontaminent with endocardial PVI alone versus the hybrid approach using epicardial ablation with endocardial ablation consisting of PVI ablation and RF ablation has not been studied using a randomized, prospective approach.
If it is found that the PVI alone is as effective as PVI plus additional catheter ablation for patients receiving a hybrid ablation, it may reduce the need for extensive catheter ablation, thereby reducing the radiation exposure, procedure time, and radiofrequency ablation time.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Medtronic Cryoballoon, Thermocool Catheter, nContact
- Keywords
- Atrial Fibrillation, Anti-Arrhythmia Agents, Catheter Ablation, surgical hybrid ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic CryoballoonDevice
For endocardial pulmonary vein Isolation, an Arctic Front Advance Cardiac CryoAblation catheter (Medtronic, Mounds view, MN, USA) will be used.
Thermocool CatheterDevice
For mapping and ablation from endocardium a 3.5 mm irrigated tip catheter (Navistar Thermocool SmartTouch Unidirectional Navigation Catheter, Biosense Webster, Diamond Bar, CA, USA) will be used.
nContactDevice
For Epicardial Ablation (the surgical portion of the Hybrid procedure), we will use the VisiTrax cardiac ablation device (nContact, Morrisville, NC, USA).
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Ablation-cryoballoon alone | Other | This group receives the hybrid surgical ablation (epicardial-endocardial ablation) with epicardial ablation and endocardial ablation consisting of pulmonary vein isolation with no further catheter ablation. This will be achieved using the nContact and Medtronic cryoballoon Receives: Device: Medtronic Cryoballoon; Device: nContact |
| Hybrid ablation-cryoballoon plus RF | Other | This group receives the hybrid surgical ablation (epicardial-endocardial ablation) with epicardial ablation and endocardial ablation. Endocardial portion consists of pulmonary vein isolation using the cryoballoon with further catheter ablation, which may consist of ablation of complex fractionated electrograms and linear lesions. This will be achieved using the nContact and Medtronic Cryoballoon plus Thermocool Catheter. Receives: Device: Medtronic Cryoballoon; Device: Thermocool Catheter; Device: nContact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success or failure in patient with persistent AF to be free of 1) AF/Atrial tachycardia(AT)/Atrial flutter(AFL) and 2) class I and Ill antiarrhythmic drugs (AAD)
The primary endpoint is success or failure in patients with persistent AF of at least 6 months duration to be AF/Atrial tachycardia (AT)/Atrial flutter (AFL) free and free of class I and III antiarrhythmic drugs (AAD) except for a previously failed or intolerant AAD in the same class following the 3 month blanking period through the 12 months post procedure follow-up visit. A failed AAD is defined as recurrence on that particular AAD.
Crossover: After the three month blanking period, if the patient is in persistent AF, the patient may undergo DCCV and antiarrhythmic medication started. The follow up will start after this date.
Measured: 12 months
Secondary outcomes (1)
Success or failure in patient with persistent AF to achieve a >90% reduction in AF burden and freedom of class I and Ill antiarrhythmic drugs (AAD)
Success or failure in patient with persistent AF of at least 6 months duration to achieve a >90% reduction in AF burden and freedom of class I and III antiarrhythmic drugs (AAD) except for a previously failed or intolerant AAD in the same class following the 3 month blanking period through the 12 months post procedure follow-up visit.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startSep 2014
- Primary completion13 Dec 2017
- Study completion13 Dec 2017
Why it stopped: Patients did not want to be randomized in hybrid ablation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jasbir S Sra, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344394
- Sponsor's protocol ID
- 14-52
- Status last verified
- Dec 2018
- First submitted
- 13 Jan 2015
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Comparison of Hybrid Ablation and Pulmonary Vein Isolation Alone Versus Hybrid Ablation With Pulmonary Vein Isolation Plus Catheter Ablation for CFAE and Linear Lesions
- ClinicalTrials.gov ID
- NCT02344394
- Acronym / sponsor ID
- 14-52
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Anti-Arrhythmia Agents, Catheter Ablation, surgical hybrid ablation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Patients did not want to be randomized in hybrid ablation.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- 13 Dec 2017 (actual)
- Study completion
- 13 Dec 2017 (actual)
- First posted
- 26 Jan 2015 (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.
The overall objective of the study is to compare and assess the clinical outcomes of the standard of care hybrid ablation using epicardial ablation in conjunction with endocardial PVI alone versus epicardial ablation in conjunction with endocardial ablation using PVI with additional RF ablation in a randomized, prospective population of patients with persistent AF of at least 6 months duration. All devices that are used are being utilized under the approved labeling of the devices.
Detailed description
Atrial fibrillation (AF) is one of the leading causes of stroke and heart failure. It is also a major cause of hospitalizations and mortality (Stewart, Wattigney, and Wolf). Patients with atrial fibrillation (AF) who are intolerant to Class I and III antiarrhythmic drugs often require endocardial ablation, which can include pulmonary vein isolation (PVI) using radiofrequency (RF) catheter ablation or cryoballoon ablation (Medtronic, MN) and reported success rates vary (Calkins et al). In patients with persistent and long standing persistent AF success rates may not be as high (Akoum et al) and there is little data analyzing outcomes for patients in this population (Calkins et al). Using an epicardial-endocardial, or hybrid, approach Gehi et al describes a 66% 12 month arrythmia-free survival rate following the procedure, with 37% patients still on antiarrythmic drug therapy at 12 months. Furthermore, a paper by Anderson et al reports that the hybrid ablation results in lower costs and higher quality adjusted life years for patients with non-paroxysmal AF as reported by the studie's results of fewer repeat ablations and maintenance of sinus rhythm at 5 years. Conflicting reports exist on how much endocardial catheter ablation is needed for patients in persistent and long standing persistent AF. Verma et al reports results for patients in persistent AF having endocardial PVI compared to P VI plus additional linear lesions. Eighteen month success rates for these patients were 59% and 46% respectively.
Success of surgical hybrid ablation using epicardial ablation cocontaminent with endocardial PVI alone versus the hybrid approach using epicardial ablation with endocardial ablation consisting of PVI ablation and RF ablation has not been studied using a randomized, prospective approach.
If it is found that the PVI alone is as effective as PVI plus additional catheter ablation for patients receiving a hybrid ablation, it may reduce the need for extensive catheter ablation, thereby reducing the radiation exposure, procedure time, and radiofrequency ablation time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid Ablation-cryoballoon alone | Other | Device: Medtronic Cryoballoon, Device: nContactThis group receives the hybrid surgical ablation (epicardial-endocardial ablation) with epicardial ablation and endocardial ablation consisting of pulmonary vein isolation with no further catheter ablation. This will be achieved using the nContact and Medtronic cryoballoon |
| Hybrid ablation-cryoballoon plus RF | Other | Device: Medtronic Cryoballoon, Device: Thermocool Catheter, Device: nContactThis group receives the hybrid surgical ablation (epicardial-endocardial ablation) with epicardial ablation and endocardial ablation. Endocardial portion consists of pulmonary vein isolation using the cryoballoon with further catheter ablation, which may consist of ablation of complex fractionated electrograms and linear lesions. This will be achieved using the nContact and Medtronic Cryoballoon plus Thermocool Catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The subject is 18 years of age or older
- Left atrium < 6.0 em (Trans Thoracic Echo - TTE- parasternal4 chamber view performed within 6 months)
- History of AF for at least 6 months
- Failed or refractory to one AAD (class I and/or Ill)
- Documentation of persistent AF
Key exclusion criteria (14 listed)
- Pregnant or planning to become pregnant during study
- Co-morbid medical conditions that limit one year life expectancy
- Previous cardiac surgery
- Previous abdominal surgery which will prevent epicardial access
- History of pericarditis
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 |
|---|---|---|
| Medtronic CryoballoonFor endocardial pulmonary vein Isolation, an Arctic Front Advance Cardiac CryoAblation catheter (Medtronic, Mounds view, MN, USA) will be used. | Device | Hybrid Ablation-cryoballoon alone, Hybrid ablation-cryoballoon plus RF |
| Thermocool CatheterFor mapping and ablation from endocardium a 3.5 mm irrigated tip catheter (Navistar Thermocool SmartTouch Unidirectional Navigation Catheter, Biosense Webster, Diamond Bar, CA, USA) will be used. | Device | Hybrid ablation-cryoballoon plus RF |
| nContactFor Epicardial Ablation (the surgical portion of the Hybrid procedure), we will use the VisiTrax cardiac ablation device (nContact, Morrisville, NC, USA). | Device | Hybrid Ablation-cryoballoon alone, Hybrid ablation-cryoballoon plus RF |
Primary outcome
Success or failure in patient with persistent AF to be free of 1) AF/Atrial tachycardia(AT)/Atrial flutter(AFL) and 2) class I and Ill antiarrhythmic drugs (AAD)
Time frame: 12 months
The primary endpoint is success or failure in patients with persistent AF of at least 6 months duration to be AF/Atrial tachycardia (AT)/Atrial flutter (AFL) free and free of class I and III antiarrhythmic drugs (AAD) except for a previously failed or intolerant AAD in the same class following the 3 month blanking period through the 12 months post procedure follow-up visit. A failed AAD is defined as recurrence on that particular AAD. Crossover: After the three month blanking period, if the patient is in persistent AF, the patient may undergo DCCV and antiarrhythmic medication started. The follow up will start after this date.
1 secondary outcome
Success or failure in patient with persistent AF to achieve a >90% reduction in AF burden and freedom of class I and Ill antiarrhythmic drugs (AAD)
Time frame: 12 months
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 3 Oct 2024.
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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.
Jasbir S Sra, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic Cryoballoon, Thermocool Catheter and nContact in people with Persistent Atrial Fibrillation, run by Wake Forest University Health Sciences at 1 site in United States.
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 7 inclusion and 14 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 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Success or failure in patient with persistent AF to be free of 1) AF/Atrial tachycardia(AT)/Atrial flutter(AFL) and 2) class I and Ill antiarrhythmic drugs (AAD) (time frame: 12 months). 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 3 Oct 2024.