Clinical TrialID 3739
2-Hydroxybenzylamine (2-HOBA) to Prevent Early Recurrence of Atrial Fibrillation After Catheter-based Ablation
NCT04433091
Atrial Fibrillation
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 3739
- Evidence Id
- 3739
- Core Evidence Id
- 3739
- Source Clinical Trial Id
- 3712
- Herb2 Clinical Trial Id
- HBCT003712
- Nct Id
- NCT04433091
- Title
- 2-Hydroxybenzylamine (2-HOBA) to Prevent Early Recurrence of Atrial Fibrillation After Catheter-based Ablation
- Status
- Active_Not_Recruiting
- Phase
- Phase 2
- Study Result
- No
- Study Condition
- Atrial Fibrillation
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION
- Intervention
- DRUG: 2-Hydroxybenzylamine|OTHER: Placebo
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Triple
- Intervention Purpose
- Prevention
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 99
- Outcome Measure
- 2-HOBA reduces the rate of early recurrence of AF, atrial tachycardia, or atrial flutter following AF ablation within 28 days follow-up, Participants will wear a smartwatch linked to an iPhone to continually record heart rate, variability and detection of arrhythmias. Participants will record a daily ECG each morning upon waking via the watch. In addition, participants will be notified by the smartwatch of 1) detection of atrial fibrillation or atrial flutter, 2) persistent high HR (\> 110 bpm) outside of exercise, Post-ablation for 28 days|A secondary analysis will analyze a surrogate of AF burden as the endpoint and designed to account for the impact of cardioversion on AF burden assessment, A continuous heart rate monitor is provided by the smartwatch.which will be assessed by the AF burden and whether or not a cardioversion was performed., Post-ablation for 28 days
- Sponsor Collaborator
- Vanderbilt University Medical Center|American Heart Association
- Funded By
- OTHER
- Location
- Vanderbilt University Medical, Nashville, Tennessee, 37232, United States
- Other Id
- 192520
- Start Date
- 2020-05-15
- Primary Completion Date
- 2024-09-16
- Completion Date
- 2024-09-16
- First Posted
- 2020-06-16
- Results First Posted
- Last Update Posted
- 2024-07-30
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT04433091
- Title Cn
- Title En
- 2-Hydroxybenzylamine (2-HOBA) to Prevent Early Recurrence of Atrial Fibrillation After Catheter-based Ablation
- Bilingual Status
- semi_complete