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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 is a Phase 3 study that was terminated before completion, run by Population Health Research Institute. The registered enrollment target is 12 participants.
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.
Interventions
- PROCEDURE Ablation
- DRUG Amiodarone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2010-08 |
| Est. Completion | 2012-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01097330
The ClinicalTrials.gov registry entry for NCT01097330 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Population Health Research Institute, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ablation is the first listed.
NCT01097330 reports 0 study locations.
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.
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