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HeartLight Ablation in Patients With Paroxysmal Atrial Fibrillation (PAF) (HeartLight)
This study has been completed.
Sponsor:
CardioFocus
Information provided by (Responsible Party):
CardioFocus
ClinicalTrials.gov Identifier:
NCT01456000
First received: October 17, 2011
Last updated: July 25, 2016
Last verified: July 2016
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Paroxysmal Atrial Fibrillation | Device: EAS-AC (HeartLight) Procedure: Control Arm Ablation | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) or HEARTLIGHT for the Treatment of Symptomatic Atrial Fibrillation |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial atrial fibrillation
MedlinePlus related topics:
Atrial Fibrillation
U.S. FDA Resources
Further study details as provided by CardioFocus:
Primary Outcome Measures:
- Number of Participants That Meeting the Efficacy Success Criteria as Described in the Outcome Measure Description [ Time Frame: 1 year ]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 for the Outcome Measure.
| Enrollment: | 405 |
| Study Start Date: | January 2012 |
| Study Completion Date: | January 2016 |
| Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: EAS-AC (HeartLight)
Treatment with the EAS-AC.
|
Device: EAS-AC (HeartLight)
Pulmonary vien isolation
|
|
Active Comparator: Control Arm Ablation
Treatment with standard ablation.
|
Procedure: Control Arm Ablation
Treatment with standard ablation.
|
Detailed Description:
A randomized, controlled trial designed to demonstrate the safety and effectiveness of the experimental device to deliver pulmonary vein isolation as a treatment for symptomatic atrial fibrillation.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01456000
Show 21 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01456000
Show 21 Study Locations
Sponsors and Collaborators
CardioFocus
Investigators
| Study Director: | Burke Barrett | CardioFocus, Inc. (sponsor) |
| Principal Investigator: | Vivek Reddy, MD | Mt. Sinai Hospital, NYC |
| Principal Investigator: | Andrea Natale, MD | Texas Cardiac Arrhythmia Research Foundation |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | CardioFocus |
| ClinicalTrials.gov Identifier: | NCT01456000 History of Changes |
| Other Study ID Numbers: |
25-3002 |
| Study First Received: | October 17, 2011 |
| Results First Received: | April 18, 2016 |
| Last Updated: | July 25, 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by CardioFocus:
|
atrial fibrillation AF PAF PVI |
ablation paroxysmal atrial fibrillation pulmonary vein isolation |
Additional relevant MeSH terms:
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on September 21, 2017