Status:
COMPLETED
2-Hydroxybenzylamine (2-HOBA) to Prevent Early Recurrence of Atrial Fibrillation After Catheter-based Ablation
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
American Heart Association
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
22+ years
Phase:
PHASE2
Brief Summary
The proposed studies will test this hypothesis by randomizing patients with AF to 2-HOBA or placebo 7 days prior to AF ablation to allow 2-HOBA to reach steady-state levels. We hypothesize that tissue...
Detailed Description
The proposed double-blind, randomized, placebo-controlled trial of 2-HOBA in patients undergoing AF ablation is designed to address the following Specific Aims: Specific Aim 1: To test the hypothesis...
Eligibility Criteria
Inclusion
- First time AF ablation with radiofrequency or cryo ablation
- Repeat AF ablation if the patient has persistent AF and ablation of non-pulmonary vein substrate is planned (e.g. posterior wall ablation, mitral or roof line, etc)
- Able to provide written, informed consent
- 22 years of age or older
Exclusion
- Planned surgical or hybrid (surgical + catheter) ablation
- Amiodarone within past 3 months
- Use of oral steroids or colchicine
- Pro-inflammatory, rheumatologic disorder (e.g. RA, SLE, IBD, psoriasis, ankylosing spondylitis)
- NYHA Class III/IV Heart Failure
- LVEF \<35%
- Active ischemia
- Hypertrophic Cardiomyopathy
- Cardiac or thoracic surgery within 6 months
- Expected life span \< 1 year
- Creatinine clearance \<30 ml/min
- Prior or planned heart transplantation
- Pregnant women
- Aspirin allergy
- Current use of MAO-I
Key Trial Info
Start Date :
May 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2023
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT04433091
Start Date
May 15 2020
End Date
January 30 2023
Last Update
November 21 2024
Active Locations (1)
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1
Vanderbilt University Medical
Nashville, Tennessee, United States, 37232