Trial · NCT01097330
Catheter Ablation Versus Amiodarone for Shock Prophylaxis in Defibrillator Patients With Ventricular Tachycardia
NCT01097330, Phase 3, Terminated, Population Health Research Institute; results first posted 2020-01-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Catheter Ablation Versus Amiodarone for Shock Prophylaxis in Defibrillator Patients With Ventricular Tachycardia. Trials, record NCT01097330. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01097330
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Catheter Ablation Versus Amiodarone for Shock Prophylaxis in Defibrillator Patients With Ventricular Tachycardia
- NCT number
- NCT01097330
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 12 participants, actual
- Lead sponsor
- Population Health Research Institute
- Conditions
- Defibrillators, Implantable, Tachycardia, Ventricular
- Interventions
- Ablation, Amiodarone
- First posted
- 2010-04-01
- Last updated
- 2020-01-29
- Results first posted
- 2020-01-29
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Appropriate ICD Therapy, Slow VT or Sudden Cardiac Death | From 30 days following randomization until final follow-up visit | 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 |
| Secondary | Number of Participants With (a) Ablation or Amiodarone Complications, (b) Inappropriate Shocks From ICD, or (c) Need for Concomitant Use of Sotalol, Dofetilide, Azimilide or Class 1 Antiarrhythmic Agents in Either Arm of the Trial. | from randomization until final follow-up | Number of Participants with (a) Ablation or Amiodarone Complications, (b) Inappropriate Shocks from ICD, or (c) Need for Concomitant use of Sotalol, Dofetilide, Azimilide or Class 1 Antiarrhythmic agents in either arm of the trial. |
| Secondary | Quality of Life Score | At 6 months follow-up | Quality of life score in each treatment arm using the EQ-5D Visual Analogue Scale (VAS) (euroqol.org). The EQ-5D VAS is a patient reported scale from 0 to 100 on which the patient rates how good or bad their health is today with 100 being the best health they can imagine and 0 being the worst health they can imagine. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Appropriate ICD Therapy, Slow VT or Sudden Cardiac Death | From 30 days following randomization until final follow-up visit | participants | NUMBER | |
| SECONDARY | Number of Participants With (a) Ablation or Amiodarone Complications, (b) Inappropriate Shocks From ICD, or (c) Need for Concomitant Use of Sotalol, Dofetilide, Azimilide or Class 1 Antiarrhythmic Agents in Either Arm of the Trial. | from randomization until final follow-up | participants | NUMBER | |
| SECONDARY | Quality of Life Score | At 6 months follow-up | Participants with data collected at 6 months | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Appropriate ICD Therapy, Slow VT or Sudden Cardiac Death | Ablation | 1 | participants | ||
| Number of Participants With Appropriate ICD Therapy, Slow VT or Sudden Cardiac Death | Amiodarone | 2 | participants | ||
Number of Participants With (a) Ablation or Amiodarone Complications, (b) Inappropriate Shocks From ICD, or (c) Need for Concomitant Use of Sotalol, Dofetilide, Azimilide or Class 1 Antiarrhythmic Agents in Either Arm of the Trial. | Ablation | 2 | participants | ||
Number of Participants With (a) Ablation or Amiodarone Complications, (b) Inappropriate Shocks From ICD, or (c) Need for Concomitant Use of Sotalol, Dofetilide, Azimilide or Class 1 Antiarrhythmic Agents in Either Arm of the Trial. | Amiodarone | 0 | participants | ||
| Quality of Life Score | Ablation | 59 | Full Range 52 to 65 | score on a scale | |
| Quality of Life Score | Amiodarone | 83 | Full Range 70 to 95 | score on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ablation | 7 | |
| Overall Study | STARTED | Amiodarone | 5 | |
| Overall Study | COMPLETED | Ablation | 0 | |
| Overall Study | COMPLETED | Amiodarone | 0 | |
| Overall Study | NOT COMPLETED | Ablation | 7 | |
| Overall Study | NOT COMPLETED | Amiodarone | 5 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | pneumonia | Infections and infestations | Ablation | 0 | 7 | 0 |
| serious | pneumonia | Infections and infestations | Amiodarone | 1 | 5 | 1 |
| serious | acute renal failure | Renal and urinary disorders | Ablation | 0 | 7 | |
| serious | acute renal failure | Renal and urinary disorders | Amiodarone | 1 | 5 | |
| serious | pseudo aneurysm | Vascular disorders | Ablation | 2 | 7 | |
| serious | pseudo aneurysm | Vascular disorders | Amiodarone | 0 | 5 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ablation | ||
| Total, all-cause mortality | Amiodarone | ||
| Total, other adverse events | Ablation | 0 | 7 |
| Total, other adverse events | Amiodarone | 0 | 5 |
| Total, serious adverse events | Ablation | 2 | 7 |
| Total, serious adverse events | Amiodarone | 1 | 5 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Ablation vs Amiodarone: Number of Participants With (a) Ablation or Amiodarone Complications, (b) Inappropriate Shocks From ICD, or (c) Need for Concomitant Use of Sotalol, Dofetilide, Azimilide or Class 1 Antiarrhythmic Agents in Either Arm of the Trial. | Trial comparisons |
| Ablation vs Amiodarone: Number of Participants With Appropriate ICD Therapy, Slow VT or Sudden Cardiac Death | Trial comparisons |
| Ablation vs Amiodarone: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01097330
GET https://conductscience.org/api/trials/v1/NCT01097330/registered