EligibleTrials

A Study of VARIPULSE Catheter in Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein and Superior Vena Cava Isolation

Recruiting · NCT07527299 · Interventional (participants receive a specific treatment) · Lead sponsor: Biosense Webster, Inc.

View the official record on ClinicalTrials.gov →
Atrial Fibrillation

Interventions studied

LAAO DeviceVARIPULSE Catheter System

What this trial is about

The purpose of this study is to assess how safe VARIPULSE catheter system is for treatment of a heart rhythm disease called persistent atrial fibrillation (PsAF) in participants who are having a catheter ablation procedure (treat heart rhythm disease). This includes isolation of pulmonary vein and superior vena cava (heart veins; pulmonary vein isolation \[PVI\] and superior vena cava isolation \[SVCI\]), with or without another technique called posterior wall isolation (PWI). Also, to assess how safe it is for participants who are having a catheter ablation procedure and at the same time receiving another procedure called left atrial appendage occlusion (LAAO; to reduce stroke risk). Additionally, to assess how well VARIPULSE catheter system works over a long period of time for treatment of PsAF in participants undergoing catheter ablation for PVI, SVCI and SVCI+PWI.

Who can take part

Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)

Inclusion criteria

Exclusion criteria

Where it is running

3 locations listed across 3 US states.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →

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