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NCT01097330 · ClinicalTrials.gov registry record · Phase 3
Catheter Ablation Versus Amiodarone for Shock Prophylaxis in Defibrillator Patients With Ventricular Tachycardia
A Phase 3 study, sponsored by Population Health Research Institute.
- Terminated
- Registry status
- Phase 3
- Development phase
- 12
- Enrollment target
NCT01097330: Clinical Trial Phase 3 study, sponsored by Population Health Research Institute.
NCT01097330 is a Phase 3 study that was terminated before completion, run by Population Health Research Institute. The registered enrollment target is 12 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01097330, a Phase 3 study, was terminated before completion, sponsored by Population Health Research Institute.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 12 participants
- Enrollment target
Study Summary
Implantable Cardioverter Defibrillators (ICDs) provide a shock or pacing therapy to bring back a normal heart beat when a patient experiences a dangerous abnormal heart rhythm such as ventricular tachycardia (VT). ICDs are very successful in bringing back a normal heart beat when VT occurs, but they do not prevent further dangerous heart rhythms from occurring. This study is designed to determine the best way to manage patients who have an ICD and who continue to have episodes of VT. There are two methods for treatment the VT: 1) Ablation, and 2) Medication. An ablation procedure involves placing a flexible catheter (insulated wire) in the groin area and threading it into the heart. After the doctor has located the affected area responsible for the VT, radiofrequency energy is delivered by the power generator through the catheter to the inside of the heart. The radiofrequency energy ablates (burns) a small area of the heart tissue thought to cause the VT. A medication called Amiodarone is an "anti-arrhythmic" prescribed to prevent abnormal heart rhythms from recurring. The purpose of this study is to compare these two different methods for treating VT. Treatment with ablation and amiodarone are both considered the standard of care for patients with VT but they have not been compared directly in a study like this before.
Primary Outcome
Number of participants with a composite outcome of any of: 1. Appropriate Implantable Cardioverter Defibrillator (ICD) therapy \[Including antitachycardia pacing (ATP) and shocks\] 2. Slow ventricular tachycardia (VT) below ICD detection threshold leading to hospitalization or necessitates antiarrhythmic medications and/or catheter ablation 3. Sudden Cardiac Death
Interventions
- PROCEDURE Ablation
- DRUG Amiodarone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2010-08 |
| Est. Completion | 2012-03 |
| Phase | Phase 3 |
Why NCT01097330 stopped before completion
NCT01097330 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Ablation is the first listed.
NCT01097330 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01097330 about?
NCT01097330 is a clinical study titled "Catheter Ablation Versus Amiodarone for Shock Prophylaxis in Defibrillator Patients With Ventricular Tachycardia". Implantable Cardioverter Defibrillators (ICDs) provide a shock or pacing therapy to bring back a normal heart beat when a patient experiences a dangerous abnormal heart rhythm such as ventricular tachycardia (VT). ICDs are very successful in bringing back a normal heart beat when VT occurs, but they...
What is the current status of trial NCT01097330?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 12 participants. The study started on 2010-08. Estimated completion is 2012-03.
What interventions are being tested in trial NCT01097330?
The interventions under investigation include: Ablation (PROCEDURE), Amiodarone (DRUG).
Who is sponsoring clinical trial NCT01097330?
This trial is sponsored by Population Health Research Institute, which has 21 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01097330's enrollment target sits among peer trials
12 1984th of 2000 higher than 12 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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