Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) (HeartLight) in Patients With Paroxysmal Atrial Fibrillation (PAF)
This study is ongoing, but not recruiting participants.
Sponsor:
CardioFocus
Information provided by (Responsible Party):
CardioFocus
ClinicalTrials.gov Identifier:
NCT01456000
First received: October 17, 2011
Last updated: February 2, 2015
Last verified: February 2015
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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:
Further study details as provided by CardioFocus:
Primary Outcome Measures:
- Freedom for documented, symptomatic atrial fibrillation [ Time Frame: 1 year ] [ Designated as safety issue: No ]Episodes of AF will be monitored during the follow-up period and the rate of subjects with no documented, symptomatic episodes of AF in follow-up will be compared.
| Estimated Enrollment: | 450 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | May 2015 |
| Primary Completion Date: | October 2013 (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 |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
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
No publications provided
| Responsible Party: | CardioFocus |
| ClinicalTrials.gov Identifier: | NCT01456000 History of Changes |
| Other Study ID Numbers: | 25-3002 |
| Study First Received: | October 17, 2011 |
| Last Updated: | February 2, 2015 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by CardioFocus:
|
atrial fibrillation AF PAF PVI |
ablation paroxysmal atrial fibrillation pulmonary vein isolation |
Additional relevant MeSH terms:
|
Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on March 01, 2015