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Clinical Trials in Israel / NCT06099730
Recruiting Not applicable

Safety and Effectiveness of Pulmonary Vein isOLation And posterioR Wall Ablation wIth pulSed Field Energy in Patients With Paroxysmal and Persistent AF

NCT06099730 · tracked via the Priya Life Science Israel tracker
Phase
Not applicable
Started
2023-12-14
Last updated
2026-07-27

Condition(s) studied

Atrial Fibrillation

Investigational drug(s) / intervention(s)

Pulsed Field Ablation (PFA)

Pulsed Field Ablation (PFA): PFA using Irreversible Electroporation (IRE) Ablation System

Study 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 subjects with symptomatic paroxysmal and persistent atrial fibrillation using the pulsed field ablation with the VARIPULSE™ catheter and the TRUPULSE™ generator.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
St. Bernard's Heart and Vascular Center Jonesboro Arkansas Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts Active Not Recruiting
Mount Sinai Hospital New York New York Not Yet Recruiting
Montefiore Medical Center New York New York Recruiting
Texas Cardiac Arrhythmia Institute/Research Foundation Austin Texas Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06099730 on ClinicalTrials.gov ↗ ← All trials in Israel