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

NCT06099730 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2025-05-06

No results posted yet for this 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.

Conditions

Interventions

DEVICE

Pulsed Field Ablation (PFA)

PFA using Irreversible Electroporation (IRE) Ablation System

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-14
Primary Completion
2026-11-30
Completion
2026-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06099730 on ClinicalTrials.gov