Atrial FibrillationICENCT02028143
ICE: Intracardiac Ultrasound Within the Left Atrium During Radiofrequency Ablation of Nonvalvular Atrial Fibrillation
A study testing Biosense Webster irrigated tip catheter, Pulmonary vein isolation and ICE catheter placed through one of two existing 8F sheaths in people with Atrial Fibrillation, run by Gregory Jones at 1 site in United States.
Trial summary
Imaging Real Time within the Left atrial chamber Enhances safety and efficacy of Radiofrequency Ablation of Atrial Fibrillation Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Biosense Webster irrigated tip catheter, Pulmonary vein isolation and ICE catheter placed through one of two existing 8F sheaths
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jan 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years
- Recommended for radiofrequency ablation of nonvalvular atrial fibrillation
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Wellmont CVA Heart Institute
Kingsport, Tennessee, 37660
About this study
Imaging Real Time within the Left atrial chamber Enhances safety and efficacy of Radiofrequency Ablation of Atrial Fibrillation
Read the detailed description
Atrial fibrillation is the most common rhythm disturbance affecting the human population.
- Its prevalence increases with age and can be found in >8% of humans over the age of eighty;
- Radiofrequency ablation for drug refractory nonvalvular atrial fibrillation has become a common therapy available to patients. It has been shown to be both efficacious and cost effective;
- The standard approach to atrial fibrillation involves electrical isolation of the pulmonary veins (PVI) from the rest of the atrium chamber. This involves moving a 3.5mm tip ablation catheter point to point around the PV structures until an encircling ablation line is formed. This can be made difficult by not knowing if the tip is in good contact with the atrial tissue. In addition the esophagus is a posterior lying structure and injury to the esophagus by ablating the overlying tissue has been reported, at times fatal;
- Currently, intracardiac imaging of the left atrium has FDA approval in the right atrial chamber. This leads to difficulty in visualizing tip tissue interface, and important left sided structures such as carina, ligaments, and esophagus. By placing the tip of the ICE catheter in the left atrium, enhanced visualization of the tip tissue interface may lead to more effective ablation points, fewer needed ablation points, and enhanced safety by avoiding placement over adjacent noncardiac structures.
- Conditions
- Atrial Fibrillation
- Being tested
- Biosense Webster irrigated tip catheter, Pulmonary vein isolation, ICE catheter placed through one of two existing 8F sheaths
- Keywords
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biosense Webster irrigated tip catheterDevice
Also called 3.5mm Biosense Webster irrigated tip catheter.
The second group (study group) will have the ICE catheter placed through one of two existing 8F sheaths already in the left atrium. The ICE catheter will be exchanged in the sheath utilizing the lasso multipolar mapping catheter during left pulmonary vein ablation lines. During exchange, suction and irrigation techniques will be utilized to avoid any air or thrombus embolization. All patients will have standard anticoagulation during the procedure with heparin infusion adjusted to an activated clotting time (ACT) of 350-400. The left sided ICE catheter will be adjusted to visualize left sided structures, ablation tip and tissue interface, and adjacent noncardiac structures such as the esophagus during radiofrequency ablation of the left pulmonary vein system.
Biosense Webster irrigated tip catheterDevice
Also called 3.5mm Biosense Webster irrigated tip catheter.
Group 1 will receive standard pulmonary vein isolation (PVI) procedure utilizing intracardiac guided ultrasound (ICE) placed within the right atrium via the femoral vein.
Pulmonary vein isolationProcedure or surgery
ICE catheter placed through one of two existing 8F sheathsProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | The study arm group will have the ICE catheter placed through one of two existing 8F sheaths already in the left atrium. The ICE catheter will be exchanged in the sheath utilizing the lasso multipolar mapping catheter during left pulmonary vein ablation lines. During exchange, suction and irrigation techniques will be utilized to avoid any air or thrombus embolization. All patients will have standard anticoagulation during the procedure with heparin infusion adjusted to an activated clotting time (ACT) of 350-400. The left sided ICE catheter will be adjusted to visualize left sided structures, ablation tip and tissue interface, and adjacent noncardiac structures such as the esophagus during radiofrequency ablation of the left pulmonary vein system. Receives: Device: Biosense Webster irrigated tip catheter; Procedure: ICE catheter placed through one of two existing 8F sheaths |
| Control arm | Active comparator | The control arm group will receive standard pulmonary vein isolation (PVI) procedure utilizing intracardiac guided ultrasound (ICE) placed within the right atrium via the femoral vein. Receives: Device: Biosense Webster irrigated tip catheter; Procedure: Pulmonary vein isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of lesions requiring ablation to obtain Electrical Isolation PV System
to assess the number of lesions requiring ablation to obtain Electrical Isolation PV system
Measured: during procedure
Secondary outcomes (1)
to assess number of lesions to obtain Electrical Isolation PV system
Evaluate the time required to obtain electrical isolation of PV system
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startNov 2013
- Primary completionJan 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gregory Jones
- Sponsor type
- University, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Responsible party
- Sponsor-investigator, Gregory Jones, Wellmont CVA Heart Institute
- Investigators
- Gregory Jones, MD, Principal investigator, Wellmont CVA Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028143
- Sponsor's protocol ID
- ICE
- Acronym
- ICE
- Status last verified
- Apr 2018
- First submitted
- 31 Dec 2013
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICE: Intracardiac Ultrasound Within the Left Atrium During Radiofrequency Ablation of Nonvalvular Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02028143
- Acronym / sponsor ID
- ICE / ICE
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Gregory JonesUniversity, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Study start
- Nov 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 7 Jan 2014 (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.
Imaging Real Time within the Left atrial chamber Enhances safety and efficacy of Radiofrequency Ablation of Atrial Fibrillation
Detailed description
Atrial fibrillation is the most common rhythm disturbance affecting the human population.
- Its prevalence increases with age and can be found in >8% of humans over the age of eighty;
- Radiofrequency ablation for drug refractory nonvalvular atrial fibrillation has become a common therapy available to patients. It has been shown to be both efficacious and cost effective;
- The standard approach to atrial fibrillation involves electrical isolation of the pulmonary veins (PVI) from the rest of the atrium chamber. This involves moving a 3.5mm tip ablation catheter point to point around the PV structures until an encircling ablation line is formed. This can be made difficult by not knowing if the tip is in good contact with the atrial tissue. In addition the esophagus is a posterior lying structure and injury to the esophagus by ablating the overlying tissue has been reported, at times fatal;
- Currently, intracardiac imaging of the left atrium has FDA approval in the right atrial chamber. This leads to difficulty in visualizing tip tissue interface, and important left sided structures such as carina, ligaments, and esophagus. By placing the tip of the ICE catheter in the left atrium, enhanced visualization of the tip tissue interface may lead to more effective ablation points, fewer needed ablation points, and enhanced safety by avoiding placement over adjacent noncardiac structures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Device: Biosense Webster irrigated tip catheter, Procedure: ICE catheter placed through one of two existing 8F sheathsThe study arm group will have the ICE catheter placed through one of two existing 8F sheaths already in the left atrium. The ICE catheter will be exchanged in the sheath utilizing the lasso multipolar mapping catheter during left pulmonary vein ablation lines. During exchange, suction and irrigation techniques will be utilized to avoid any air or thrombus embolization. All patients will have standard anticoagulation during the procedure with heparin infusion adjusted to an activated clotting time (ACT) of 350-400. The left sided ICE catheter will be adjusted to visualize left sided structures, ablation tip and tissue interface, and adjacent noncardiac structures such as the esophagus during radiofrequency ablation of the left pulmonary vein system. |
| Control arm | Active comparator | Device: Biosense Webster irrigated tip catheter, Procedure: Pulmonary vein isolationThe control arm group will receive standard pulmonary vein isolation (PVI) procedure utilizing intracardiac guided ultrasound (ICE) placed within the right atrium via the femoral vein. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 to 80 years
- Recommended for radiofrequency ablation of nonvalvular atrial fibrillation
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Biosense Webster irrigated tip catheterAlso: 3.5mm Biosense Webster irrigated tip catheter.The second group (study group) will have the ICE catheter placed through one of two existing 8F sheaths already in the left atrium. The ICE catheter will be exchanged in the sheath utilizing the lasso multipolar mapping catheter during left pulmonary vein ablation lines. During exchange, suction and irrigation techniques will be utilized to avoid any air or thrombus embolization. All patients will have standard anticoagulation during the procedure with heparin infusion adjusted to an activated clotting time (ACT) of 350-400. The left sided ICE catheter will be adjusted to visualize left sided structures, ablation tip and tissue interface, and adjacent noncardiac structures such as the esophagus during radiofrequency ablation of the left pulmonary vein system. | Device | Study arm |
| Biosense Webster irrigated tip catheterAlso: 3.5mm Biosense Webster irrigated tip catheter.Group 1 will receive standard pulmonary vein isolation (PVI) procedure utilizing intracardiac guided ultrasound (ICE) placed within the right atrium via the femoral vein. | Device | Control arm |
| Pulmonary vein isolation | Procedure or surgery | Control arm |
| ICE catheter placed through one of two existing 8F sheaths | Procedure or surgery | Study arm |
Primary outcome
number of lesions requiring ablation to obtain Electrical Isolation PV System
Time frame: during procedure
to assess the number of lesions requiring ablation to obtain Electrical Isolation PV system
1 secondary outcome
to assess number of lesions to obtain Electrical Isolation PV system
Time frame: during procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
Gregory Jones, MD principal investigator
Wellmont CVA Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biosense Webster irrigated tip catheter, Pulmonary vein isolation and ICE catheter placed through one of two existing 8F sheaths in people with Atrial Fibrillation, run by Gregory Jones 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 24 Apr 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
number of lesions requiring ablation to obtain Electrical Isolation PV System (time frame: during procedure). 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 24 Apr 2018.