Phase 3
Completed N=353
HeartLight Ablation in Patients With Paroxysmal Atrial Fibrillation (PAF)
Source: ClinicalTrials.gov NCT01456000 ↗Enrolled (actual)
353
Serious AEs
7.6%
Results posted
Sep 2016
Primary outcomePrimary: Number of Participants That Meeting the Efficacy Success Criteria as Described in the Outcome Measure Description — 102; 103 Successful Participants
◆ Published Evidence
Highly cited
212citations · ~19 / year
Pulmonary Vein Isolation Using the Visually Guided Laser Balloon: A Prospective, Multicenter, and Randomized Comparison to Standard Radiofrequency Ablation.
Summary
The purpose of this study is to demonstrate the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact (HeartLight) in the treatment of atrial fibrillation by creating electrical isolation of the pulmonary veins.
Linked Publications
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Pulmonary Vein Isolation Using the Visually Guided Laser Balloon: A Prospective, Multicenter, and Randomized Comparison to Standard Radiofrequency Ablation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Meeting the Efficacy Success Criteria as Described in the Outcome Measure Description |
102; 103 | — |
Eligibility Criteria
Inclusion Criteria
- 18 to 75 years.
- paroxysmal atrial fibrillation
- failure of at least one AAD
- others
Exclusion Criteria
- overall good health as established by multiple criteria
Data sourced from ClinicalTrials.gov (NCT01456000) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.