BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF

Recruiting N/A Interventional Study
Paroxysmal AF Atrial Arrhythmia Atrial Fibrillation Persistent Atrial Fibrillation
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
300 (estimated)
Sponsor
Abbott Medical Devices · Industry
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About This Trial

This study is designed to obtain real-world clinical evidence on the safety and effectiveness of the Volt PFA System in various use cases, with a sub study designed to address additional clinical evidence needs in electrophysiology.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Documented symptomatic PAF or PersAF. Documentation requirements are as follows: Paroxysmal: * Physician's note indicating recurrent self-terminating AF AND * One electrocardiographically documented PAF episode within 12 months prior to enrollment. Persistent: C…
Contacts

Karolilen Timmermans

+3222006511

karolien.timmermans@abbott.com

CONTACT

Christine Sasaridis

christine.sasaridis@abbott.com

CONTACT