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| Name | Class |
|---|---|
| Mercy General Hospital and Dignity Health Medical Foundation | UNKNOWN |
| Beth Israel Deaconess Medical Center | OTHER |
| UC Health Medical Center | UNKNOWN |
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The purpose of this study it to learn whether pulmonary vein isolation (PVI) along with isolation of the posterior left atrial wall (PWI) in the region of the pulmonary venous component will reduce the likelihood of atrial fibrillation (AF) recurrence in patients with persistent atrial fibrillation at 12 months, after a single ablation procedure, in comparison to PVI alone.
The investigator hypothesizes that the combination of PVI + PWI will result in a significant reduction in recurrence of atrial fibrillation at 12 months after ablation.
Patients with persistent atrial fibrillation will be enrolled in this multi-center, randomized, prospective, single-blinded study. After catheter ablation (isolation) of the pulmonary veins (PVI) and while still in the cardiac electrophysiology laboratory, all patients will be randomized to either PVI alone or the combination of PVI + posterior left atrial wall isolation (PWI). For patients randomized to PVI, their ablation procedure will be completed at that time. For those patients randomized to PVI + PWI, they will have additional ablation to achieve PWI.
All study patients will have the same follow-up after their ablation procedure, including clinic visits at 3, 6, and 12 months and a heart event monitor for 7-14 days before these visits. An echocardiogram (heart ultrasound) is performed at 6 to 12 months after the ablation. Blood thinners are recommended for two months after ablation and then the need for continued use of blood thinners will be based on individual patient's medical history, stroke risk and the decision of the study doctor. Information about the patients' medical history, heart arrhythmias and atrial fibrillation will be collected during the study which will be analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Cryoballoon Pulmonary Vein Isolation (PVI) | Active Comparator | Standard cryoballoon pulmonary vein isolation alone using the Arctic Front Advance Cryoablation System family of cardiac ablation catheters |
|
| Cryoballoon PVI + Posterior Wall Isolation | Experimental | Cryoballoon pulmonary vein isolation in conjunction with posterior wall isolation using the Arctic Front Advance Cryoablation System family of cardiac ablation catheters |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Cryoballoon Pulmonary Vein Isolation (PVI) | Procedure | Arctic Front Advance cryoballoon ablation system to ablate the pulmonary veins to achieve PVI alone |
|
| Measure | Description | Time Frame |
|---|---|---|
| 12-month freedom from recurrent atrial fibrillation | Number of participants with recurrent atrial fibrillation following catheter ablation | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| All atrial arrhythmia recurrences | Number of atrial arrhythmia recurrences after the 90-day blanking period | During a follow-up period of 12 months |
| Change in Canadian Cardiovascular Society Severity of Atrial Fibrillation Scale (CCS-SAF) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arash Aryana, MD | Mercy General Hospital and Dignity Health Medical Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mercy General Hospital and Dignity Health Medical Foundation | Sacramento | California | 95819 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33009645 | Derived | Aryana A, Pujara DK, Allen SL, Baker JH, Espinosa MA, Buch EF, Srivatsa U, Ellis E, Makati K, Kowalski M, Lee S, Tadros T, Baykaner T, Al-Ahmad A, d'Avila A, Di Biase L, Okishige K, Natale A. Left atrial posterior wall isolation in conjunction with pulmonary vein isolation using cryoballoon for treatment of persistent atrial fibrillation (PIVoTAL): study rationale and design. J Interv Card Electrophysiol. 2021 Oct;62(1):187-198. doi: 10.1007/s10840-020-00885-w. Epub 2020 Oct 3. |
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| MedStar Georgetown University Hospital |
| OTHER |
| Tampa Cardiac Specialists | UNKNOWN |
| Bethesda North Hospital | UNKNOWN |
| Brigham and Women's Hospital | OTHER |
| Texas Cardiac Arrhythmia Institute At St. Davids Medical Center | UNKNOWN |
| St. Luke's Hospital and Health Network, Pennsylvania | OTHER |
| Sarasota Memorial Health Care System | OTHER |
| Nebraska Methodist Hospital-Methodist Physicians Clinic | UNKNOWN |
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|
| Cryoballoon PVI + Posterior Wall Isolation | Device | Arctic Front Advance Cardiac Cryoballoon Ablation System to ablate the pulmonary veins and the left atrial posterior wall to achieve PVI + posterior wall isolation within the region of the pulmonary venous component |
|
|
Change in CCS-SAF from baseline to 12 months
| During a follow-up period of 12 months |
| Change in Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT) | Change in AFEQT from baseline to 12 months | During a follow-up period of 12 months |
| Multiple procedure success | Absence of recurrent atrial arrhythmias after one or more ablation procedure(s) | During a follow-up period of 12 months |
| Relative reduction in atrial fibrillation burden | Reduction in the burden of atrial fibrillation (in percentage) following catheter ablation | During a follow-up period of 12 months |
| Freedom from cardioversion for recurrent atrial arrhythmias | Electrical or pharmacological cardioversion for treatment of recurrent atrial arrhythmias not required | During a follow-up period of 12 months |
| Freedom from repeat atrial fibrillation ablation | Repeat ablation for atrial fibrillation | During a follow-up period of 12 months |
| Left Atrial Diameter (Size) as predictor of atrial fibrillation recurrence | Change in left atrial diameter (in millimeters) following ablation | During a follow-up period of 12 months |
| Left Ventricular Ejection Fraction as predictor of atrial fibrillation recurrence | Change in left atrial ejection fraction (in percentage) following ablation | During a follow-up period of 12 months |
| New York Heart Association Functional Class as predictor of atrial fibrillation recurrence | Change in New York Heart Association Functional Class following ablation | During a follow-up period of 12 months |
| UCHealth Medical Center |
| Fort Collins |
| Colorado |
| 80528 |
| United States |
| MedStar Georgetown University Hospital and Medical Center | Washington D.C. | District of Columbia | 20007 | United States |
| Sarasota Memorial Health Care System | Sarasota | Florida | 34239 | United States |
| Tampa Cardiac Specialists | Tampa | Florida | 33558 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Nebraska Methodist Hospital-Methodist Physicians Clinic | Omaha | Nebraska | 68114 | United States |
| Bethesda North Hospital | Cincinnati | Ohio | 45242 | United States |
| St. Luke's University Health Network | Bethlehem | Pennsylvania | 18015 | United States |
| Texas Cardiac Arrhythmia Institute & St. David's Medical Center | Austin | Texas | 78705 | United States |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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