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NCT01984346 · ClinicalTrials.gov registry record · NA
CONVERGE - Epi/Endo Ablation For Treatment of Persistent Atrial Fibrillation(AF)
A NA study, sponsored by AtriCure.
- Completed
- Registry status
- NA
- Development phase
- 170
- Enrollment target
NCT01984346: Completed NA study, sponsored by AtriCure.
NCT01984346 is a NA study that has completed, run by AtriCure. The registered enrollment target is 170 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01984346, a NA study, has completed, sponsored by AtriCure.
- COMPLETED
- Registry status
- NA
- Development phase
- 170 participants
- Enrollment target
Study Summary
This is a multi-center, open label, randomized pivotal study evaluating the safety and efficacy of the EPi-Sense-AF Guided Coagulation System for the treatment of persistent AF patients, refractory or intolerant to at least one Class I and/or III Anti Arrhythmic Drug (AAD).
Primary Outcome
This binary primary endpoint measures number of patients to achieve freedom from AF/AT/AFL absent class I and III AADs except for previously failed or intolerant I or III AAD with no increase in dosage following the 3-month blanking period through the 12 months post procedure follow-up visit will be compared between the two treatment groups using a chi-square test using a two-sided alpha of .05 to determine if superiority of the treatment arm is attained.
Interventions
- DEVICE AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax
- DEVICE Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2013-12 |
| Est. Completion | 2023-10 |
| Phase | NA |
What the finished NCT01984346 record still lists
NCT01984346 is an interventional study that assigns participants to a tested intervention. The registered 170 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax is the first listed.
NCT01984346 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01984346 about?
NCT01984346 is a clinical study titled "CONVERGE - Epi/Endo Ablation For Treatment of Persistent Atrial Fibrillation(AF)". This is a multi-center, open label, randomized pivotal study evaluating the safety and efficacy of the EPi-Sense-AF Guided Coagulation System for the treatment of persistent AF patients, refractory or intolerant to at least one Class I and/or III Anti Arrhythmic Drug (AAD).
What is the current status of trial NCT01984346?
This trial is currently completed. It is a NA study. The enrollment target is 170 participants. The study started on 2013-12. Estimated completion is 2023-10.
What interventions are being tested in trial NCT01984346?
The interventions under investigation include: AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax (DEVICE), Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering (DEVICE).
Who is sponsoring clinical trial NCT01984346?
This trial is sponsored by AtriCure, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01984346's enrollment target sits among peer trials
170 614th of 2000 higher than 1,382 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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