Status:
COMPLETED
RADAR Clinical Trial
Lead Sponsor:
Vivek Reddy
Collaborating Sponsors:
AFTx, Inc.
Conditions:
Persistent Atrial Fibrillation
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
This prospective, multicenter, observational study will examine the ability of real time electrogram processing mapping to identify driver domains to target for ablation in persistent AF patients.
Detailed Description
ABSTRACT: Recent clinical trials have shown that targeting rotors and focal impulses (FIs) during atrial fibrillation (AF) ablation improves outcomes. This study evaluated whether a novel computationa...
Eligibility Criteria
Inclusion
- ≥ 18 years of age.
- Patients are considered eligible if they have symptomatic or drug-refractory AF and are planned to undergo a catheter ablation procedure for persistent AF (ether a first procedure or a redo procedure)
- Ability to understand the requirements of the study and sign the informed consent form.
- Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements
- Projected lifespan greater than 1 year.
Exclusion
- They have long-standing persistent AF prior to the first procedure (defined as AF greater than one year's duration).
- Rheumatic heart disease
- Current intra-cardiac thrombus
- History of MI or Coronary Artery Bypass Grafting (CABG) within 6 weeks
- Unstable angina
- CVA or TIA within 3 months
- Contraindication to anticoagulation
- Class IV HF
- Unable to sign consent
- Projected lifespan of \< 1 year
- Women known to be pregnant or to have positive beta-HCG (Human Chorionic Gonadotropin).
- Participation in another study that would interfere with this study.
Key Trial Info
Start Date :
June 26 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2019
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT03263702
Start Date
June 26 2017
End Date
June 7 2019
Last Update
May 13 2020
Active Locations (4)
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1
University of Colorado Medical Center
Denver, Colorado, United States, 80045
2
South Denver Cardiology
Denver, Colorado, United States, 80120
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029