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.
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