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A prospective multi-arm parallel group randomized clinical trial to compare the efficacy of three ablation strategies in patients with persistent atrial fibrillation using using a lattice-tip catheter that can switch between RFA and PFA energy. The incremental benefit of posterior wall isolation (PWI) and mitral isthmus ablation may contribute to greater freedom from atrial fibrillation at twelve months.
This is a prospective randomized clinical trial. Patients will undergo catheter ablation for persistent AF using a lattice-tip catheter that can switch between RFA and PFA energy. Enrolled patients will be randomized to one of three ablation strategies:
Patients will receive an implantable loop recorder prior to, during or post index ablation procedure for continuous monitoring for clinical recurrence of AF/AT/AFL
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PVI using PFA energy | Active Comparator | Pulmonary vein isolation using PFA energy |
|
| PVI and posterior wall isolation using PFA energy | Active Comparator | Pulmonary vein isolation and posterior wall isolation using PFA energy |
|
| PVI and posterior wall isolation (PFA) and mitral isthmus ablation using RFA or PFA energy. | Active Comparator | Pulmonary vein isolation and posterior wall isolation (PFA) and mitral isthmus ablation using RFA or PFA energy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter Ablation | Procedure | This is a prospective randomized clinical trial. Patients will undergo catheter ablation for persistent AF using a lattice-tip catheter that can switch between RFA and PFA energy. Enrolled patients will be randomized to one of three ablation strategies: |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of subjects free from primary effectiveness failure | The primary effectiveness endpoint is freedom from documented recurrence of AF, atrial tachycardia (AT), or atrial flutter (AFL) lasting >2 minutes based on electrocardiographic data through 12-month follow-up and excluding a 60-day blanking period. | 12 Months |
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Inclusion Criteria:
1. Symptomatic PerAF documented by
(1a) a physician's note indicating symptoms consistent with AF sustained longer than 7 days but less than 12 months; AND electrocardiographic evidence
2. . Suitable candidate for catheter ablation.
3. . Adults aged 18 - 80 years.
4. . Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristie Coleman, MPH, RN | Contact | 2124346500 | kcoleman1@Northwell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Stavros Mountantonakis, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Shore University Hospital | Recruiting | Manhasset | New York | 11030 | United States |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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Patients will be blinded to the ablation strategy they are randomized to
|
| Long Island Jewish Medical Center | Recruiting | New Hyde Park | New York | 11040 | United States |
|
| Kristie Coleman | Recruiting | New York | New York | 10075 | United States |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013514 |
| Surgical Procedures, Operative |