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NCT01416935 · ClinicalTrials.gov registry record · NA
Necessity of Anti-Arrhythmic Medication After Surgical Ablation for Atrial Fibrillation
A NA study, sponsored by Inova Health Care Services.
- Terminated
- Registry status
- NA
- Development phase
- 186
- Enrollment target
NCT01416935: Clinical Trial NA study, sponsored by Inova Health Care Services.
NCT01416935 is a NA study that was terminated before completion, run by Inova Health Care Services. The registered enrollment target is 186 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01416935, a NA study, was terminated before completion, sponsored by Inova Health Care Services.
- TERMINATED
- Registry status
- NA
- Development phase
- 186 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether anti arrhythmic medication, specifically Amiodarone, is required during the first three months post surgical ablation. Hypothesis: Amiodarone will not be required during the first three months as verified by no increase in rehospitalizations for recurrent Atrial Fibrillation, and report of sinus rhythm at surgical follow up (approximately 3 weeks from date of surgery), 6 weeks and 12 weeks to include patients' first follow up with cardiologist at approximately 3 months post surgery.
Primary Outcome
To demonstrate equality in clinically significant recurrence of AF following ablation while showing superiority for complication and side effect rates in those off Amiodarone vs. those on. •% recurrence AF by telemetry at 3 wks and 24-48 hr Holter monitoring at 6 and 12 wks post procedure, EKG at first visit between 6 and 12 wks post discharge and or ER visit for rapid heart rate in atrial arrhythmia requiring treatment; permanent pacemaker interrogation reports at first follow up visit. •Post
Interventions
- OTHER No Amiodarone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 186 participants |
| Start Date | 2011-01-01 |
| Est. Completion | 2016-07 |
| Phase | NA |
Why NCT01416935 stopped before completion
NCT01416935 is an interventional study that assigns participants to a tested intervention. The registered 186 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 (87% lower).
The record links to 0 conditions, and to 1 intervention - of which No Amiodarone is the first listed.
NCT01416935 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01416935 about?
NCT01416935 is a clinical study titled "Necessity of Anti-Arrhythmic Medication After Surgical Ablation for Atrial Fibrillation". The purpose of this study is to determine whether anti arrhythmic medication, specifically Amiodarone, is required during the first three months post surgical ablation. Hypothesis: Amiodarone will not be required during the first three months as verified by no increase in rehospitalizations for rec...
What is the current status of trial NCT01416935?
This trial is currently terminated. It is a NA study. The enrollment target is 186 participants. The study started on 2011-01-01. Estimated completion is 2016-07.
What interventions are being tested in trial NCT01416935?
The interventions under investigation include: No Amiodarone (OTHER).
Who is sponsoring clinical trial NCT01416935?
This trial is sponsored by Inova Health Care Services, which has 75 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01416935's enrollment target sits among peer trials
186 579th of 2000 higher than 1,421 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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