Status:
ACTIVE_NOT_RECRUITING
Safety and Effectiveness of Pulmonary Vein isOLation And posterioR Wall Ablation wIth pulSed Field Energy in Patients With Paroxysmal and Persistent AF
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The primary objective of this clinical investigation is to demonstrate the safety and 12-month effectiveness of pulmonary vein isolation (PVI) and posterior LA wall isolation in the treatment of subje...
Eligibility Criteria
Inclusion
- Symptomatic paroxysmal and persistent AF with at least one AF episode electrocardiographically documented within 24 months prior to enrollment. Electrocardiographic documentation may include, but is not limited to ECG, Transtelephonic monitoring (TTM), Zio patch monitor, telemetry strip, or consumer devices
- Age 18-80 years
- Willing and capable of providing written consent
- Able and willing to comply with all pre-, post- and follow-up testing and requirements.
Exclusion
- Previous surgical or catheter ablation for AF
- Documented LA thrombus by imaging within 48 hours before procedure (CT, TEE, or intracardiac echocardiogram at the beginning of the procedure).
- Uncontrolled heart failure or New York Heart Association (NYHA) Class IV
- History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
- Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
- Presence of implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device that may interfere with the PFA energy field
- Women who are pregnant (as evidenced by pregnancy test if pre- menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation
- Life expectancy less than 12 months
- Currently enrolled in an investigational study evaluating another device, biologic, or drug that would interfere with this trial
Key Trial Info
Start Date :
December 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT06099730
Start Date
December 14 2023
End Date
November 1 2026
Last Update
May 6 2025
Active Locations (7)
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1
St. Bernard's Heart and Vascular Center
Jonesboro, Arkansas, United States, 72401
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
4
Mount Sinai Hospital
New York, New York, United States, 10029