Phase 3
N=353
HeartLight Ablation in Patients With Paroxysmal Atrial Fibrillation (PAF)
Paroxysmal Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT01456000 ↗Enrolled (actual)
353
Serious AEs
7.6%
Results posted
Sep 2016
Primary outcome: Primary: Number of Participants That Meeting the Efficacy Success Criteria as Described in the Outcome Measure Description — 102; 103 Successful Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- EAS-AC (HeartLight) (Device); Control Arm Ablation (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CardioFocus
- Primary completion
- Dec 2014
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 | — |
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.
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). 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.