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NCT01456000 · ClinicalTrials.gov registry record · Phase 3
HeartLight Ablation in Patients With Paroxysmal Atrial Fibrillation (PAF)
A Phase 3 study, sponsored by CardioFocus.
- Completed
- Registry status
- Phase 3
- Development phase
- 405
- Enrollment target
NCT01456000: Completed Phase 3 study, sponsored by CardioFocus.
NCT01456000 is a Phase 3 study that has completed, run by CardioFocus. The registered enrollment target is 405 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01456000, a Phase 3 study, has completed, sponsored by CardioFocus.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 405 participants
- Enrollment target
Study 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.
Primary Outcome
Episodes of AF were monitored during the follow-up period and the rate of participants with no documented, symptomatic episodes of AF in follow-up were be compared. Other efficacy success/failure criteria included acute isolation of all clinically relevant pulmonary veins, lack of ablation-induced left atrial flutter, use of AADs during a follow-up period and left heart ablation or implant for AF in follow-up. Randomized and treated participants that were evaluable for efficacy are reported on f
Interventions
- DEVICE EAS-AC (HeartLight)
- PROCEDURE Control Arm Ablation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 405 participants |
| Start Date | 2012-01 |
| Est. Completion | 2016-01 |
| Phase | Phase 3 |
What the finished NCT01456000 record still lists
NCT01456000 is an interventional study that assigns participants to a tested intervention. The registered 405 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 2 interventions - of which EAS-AC (HeartLight) is the first listed.
NCT01456000 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01456000 about?
NCT01456000 is a clinical study titled "HeartLight Ablation in Patients With Paroxysmal Atrial Fibrillation (PAF)". 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.
What is the current status of trial NCT01456000?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 405 participants. The study started on 2012-01. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01456000?
The interventions under investigation include: EAS-AC (HeartLight) (DEVICE), Control Arm Ablation (PROCEDURE).
Who is sponsoring clinical trial NCT01456000?
This trial is sponsored by CardioFocus, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01456000's enrollment target sits among peer trials
405 914th of 2000 higher than 1,087 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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