MedTrace Logo

Exploratory Safety and Effectiveness Evaluation of Pulsed Field Ablation (PFA) by Balloon Catheter With TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF)

NCT06495216 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-02-04

No results posted yet for this study

Summary

The purpose of this study is to explore preliminary safety and acute effectiveness of pulsed field ablation by the ablation system (pulsed field ablation balloon catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF), an irregular heart rate that causes abnormal blood flow.

Conditions

Interventions

DEVICE

Pulsed Field Ablation by a Balloon Catheter with the TRUPULSE Generator

Pulsed field ablation balloon catheter and TRUPULSE generator will be used for PV ablation.

Sponsors & Collaborators

  • Biosense Webster, Inc.

    lead INDUSTRY

Principal Investigators

  • Biosense Webster, Inc. Clinical Trial · Biosense Webster, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-08-17
Primary Completion
2025-03-26
Completion
2025-12-26

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 NCT06495216 on ClinicalTrials.gov