Left Atrial Posterior Wall and PV Isolation Using Cryoballoon for Treatment of Persistent AF
NCT ID: NCT04505163
Last Updated: 2023-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
153 participants
INTERVENTIONAL
2021-04-30
2024-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Standard Cryoballoon Pulmonary Vein Isolation (PVI)
Standard cryoballoon pulmonary vein isolation alone using the Arctic Front Advance Cryoablation System family of cardiac ablation catheters
Standard Cryoballoon Pulmonary Vein Isolation (PVI)
Arctic Front Advance cryoballoon ablation system to ablate the pulmonary veins to achieve PVI alone
Cryoballoon PVI + Posterior Wall Isolation
Cryoballoon pulmonary vein isolation in conjunction with posterior wall isolation using the Arctic Front Advance Cryoablation System family of cardiac ablation catheters
Cryoballoon PVI + Posterior Wall Isolation
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
Interventions
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Standard Cryoballoon Pulmonary Vein Isolation (PVI)
Arctic Front Advance cryoballoon ablation system to ablate the pulmonary veins to achieve PVI alone
Cryoballoon PVI + Posterior Wall Isolation
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have symptomatic Persistent AF refractory or intolerant to at least one class I or class III antiarrhythmic drug
* Males and females with an age \>18 years undergoing a first-time catheter ablation of AF; prior ablation of a right atrial cardiac arrhythmia (i.e., typical right atrial flutter) is permitted
* All patients must understand the requirements of the study and be willing to comply with the post-study follow-up requirements
* Patients must have documented episode of AF greater than 7 days in the year prior to the procedure
Exclusion Criteria
* Any reversible cause of AF (post-operative, thyroid disorder, etc.)
* Patients with cerebral ischemic events (stroke or transient ischemic attack), myocardial infarction or unstable angina in the previous 2 months
* Patients with any corrected or uncorrected congenital heart disease
* Patients with a history of hypertrophic cardiomyopathy
* Patients with cardiomyopathy and a left ventricular ejection fraction \<40%
* Congestive heart failure, class IV
* Left atrial (LA) diameter \>55 mm (parasternal long axis view)
* Patients with left atrial thrombus
* Women who are known to be pregnant or have had a positive β-HCG (human chorionic gonadotropin) test 7 days prior to procedure
* Patients whose life expectancy is \<1 year
* History of left-sided left atrial ablation (catheter or surgically-based)
* Mental impairment precluding the patient from providing informed consent or completing appropriate follow-up
18 Years
ALL
No
Sponsors
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Mercy General Hospital and Dignity Health Medical Foundation
UNKNOWN
Beth Israel Deaconess Medical Center
OTHER
UC Health Medical Center
UNKNOWN
MedStar Georgetown University Hospital and Medical Center
UNKNOWN
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
Dignity Health Medical Foundation
OTHER
Responsible Party
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Arash Aryana, MD
Principal Investigator
Principal Investigators
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Arash Aryana, MD
Role: PRINCIPAL_INVESTIGATOR
Mercy General Hospital and Dignity Health Medical Foundation
Locations
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Mercy General Hospital and Dignity Health Medical Foundation
Sacramento, California, United States
UCHealth Medical Center
Fort Collins, Colorado, United States
MedStar Georgetown University Hospital and Medical Center
Washington D.C., District of Columbia, United States
Sarasota Memorial Health Care System
Sarasota, Florida, United States
Tampa Cardiac Specialists
Tampa, Florida, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Nebraska Methodist Hospital-Methodist Physicians Clinic
Omaha, Nebraska, United States
Bethesda North Hospital
Cincinnati, Ohio, United States
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States
Texas Cardiac Arrhythmia Institute & St. David's Medical Center
Austin, Texas, United States
Countries
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References
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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.
Other Identifiers
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PIVoTAL-IDE
Identifier Type: -
Identifier Source: org_study_id
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