Trial Outcomes & Findings for INTERVENE: Indian Trial of Endocardial Ventricular Substrate Ablation to Prevent Recurrent VT Events (NCT NCT02301390)
NCT ID: NCT02301390
Last Updated: 2020-01-27
Results Overview
Number of participants who had no occurrences of all-cause mortality, sustained ventricular tachycardia (VT) and cardiac arrest at 24 months
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
53 participants
Primary outcome timeframe
at 24 months
Results posted on
2020-01-27
Participant Flow
Participant milestones
| Measure |
Amiodarone Only
Amiodarone is a Class III antiarrhythmic agent.
|
Amiodarone + Catheter Ablation
Amiodarone is a Class III antiarrhythmic agent.
Catheter VT Ablation: The ablation procedure uses radiofrequency energy to destroy cardiac tissue at the origin of the arrhythmia.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
26
|
|
Overall Study
COMPLETED
|
17
|
13
|
|
Overall Study
NOT COMPLETED
|
10
|
13
|
Reasons for withdrawal
| Measure |
Amiodarone Only
Amiodarone is a Class III antiarrhythmic agent.
|
Amiodarone + Catheter Ablation
Amiodarone is a Class III antiarrhythmic agent.
Catheter VT Ablation: The ablation procedure uses radiofrequency energy to destroy cardiac tissue at the origin of the arrhythmia.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
5
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Death
|
2
|
2
|
|
Overall Study
Procedure not completed
|
0
|
4
|
|
Overall Study
Missed multiple visits
|
1
|
1
|
|
Overall Study
study terminated
|
2
|
0
|
Baseline Characteristics
INTERVENE: Indian Trial of Endocardial Ventricular Substrate Ablation to Prevent Recurrent VT Events
Baseline characteristics by cohort
| Measure |
Amiodarone Only
n=27 Participants
Amiodarone is a Class III antiarrhythmic agent.
|
Amiodarone + Catheter Ablation
n=26 Participants
Amiodarone is a Class III antiarrhythmic agent.
Catheter VT Ablation: The ablation procedure uses radiofrequency energy to destroy cardiac tissue at the origin of the arrhythmia.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.9 years
STANDARD_DEVIATION 10.7 • n=99 Participants
|
53.8 years
STANDARD_DEVIATION 10.4 • n=107 Participants
|
54.3 years
STANDARD_DEVIATION 10.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
27 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: at 24 monthsNumber of participants who had no occurrences of all-cause mortality, sustained ventricular tachycardia (VT) and cardiac arrest at 24 months
Outcome measures
| Measure |
Amiodarone Only
n=27 Participants
Amiodarone is a Class III antiarrhythmic agent.
|
Amiodarone + Catheter Ablation
n=26 Participants
Amiodarone is a Class III antiarrhythmic agent.
Catheter VT Ablation: The ablation procedure uses radiofrequency energy to destroy cardiac tissue at the origin of the arrhythmia.
|
|---|---|---|
|
Number of Participants Who Were Free From All-cause Mortality, Sustained VT or Cardiac Arrest
|
16 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: up to 24 monthsNumber of subjects that die within 30 days or die by 24 months.
Outcome measures
| Measure |
Amiodarone Only
n=27 Participants
Amiodarone is a Class III antiarrhythmic agent.
|
Amiodarone + Catheter Ablation
n=26 Participants
Amiodarone is a Class III antiarrhythmic agent.
Catheter VT Ablation: The ablation procedure uses radiofrequency energy to destroy cardiac tissue at the origin of the arrhythmia.
|
|---|---|---|
|
Number of Participant Who Died
within 30 days
|
0 Participants
|
0 Participants
|
|
Number of Participant Who Died
24 months
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: at 24 monthsTotal number of ventricular arrhythmic events, compared between the 2 treatment arms.
Outcome measures
| Measure |
Amiodarone Only
n=27 Participants
Amiodarone is a Class III antiarrhythmic agent.
|
Amiodarone + Catheter Ablation
n=26 Participants
Amiodarone is a Class III antiarrhythmic agent.
Catheter VT Ablation: The ablation procedure uses radiofrequency energy to destroy cardiac tissue at the origin of the arrhythmia.
|
|---|---|---|
|
Ventricular Arrhythmic Events
|
15 events
|
5 events
|
SECONDARY outcome
Timeframe: baseline and 24 monthsPopulation: Data for only those who had two time points LV ejection fraction data
Change in left ventricle (LV) ejection fraction between paired measurements recorded at 24 months as compared to baseline
Outcome measures
| Measure |
Amiodarone Only
n=14 Participants
Amiodarone is a Class III antiarrhythmic agent.
|
Amiodarone + Catheter Ablation
n=8 Participants
Amiodarone is a Class III antiarrhythmic agent.
Catheter VT Ablation: The ablation procedure uses radiofrequency energy to destroy cardiac tissue at the origin of the arrhythmia.
|
|---|---|---|
|
Change in LV Ejection Fraction
|
1.85 percent
Standard Deviation 6.32
|
8 percent
Standard Deviation .31
|
Adverse Events
Amiodarone Only
Serious events: 11 serious events
Other events: 4 other events
Deaths: 2 deaths
Amiodarone + Catheter Ablation
Serious events: 8 serious events
Other events: 6 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Amiodarone Only
n=27 participants at risk
Amiodarone is a Class III antiarrhythmic agent.
|
Amiodarone + Catheter Ablation
n=26 participants at risk
Amiodarone is a Class III antiarrhythmic agent.
Catheter VT Ablation: The ablation procedure uses radiofrequency energy to destroy cardiac tissue at the origin of the arrhythmia.
|
|---|---|---|
|
Cardiac disorders
VT recurrrence
|
37.0%
10/27 • 24 months
|
19.2%
5/26 • 24 months
|
|
Cardiac disorders
Bradycardia
|
3.7%
1/27 • 24 months
|
0.00%
0/26 • 24 months
|
|
Cardiac disorders
Heart Failure
|
7.4%
2/27 • 24 months
|
3.8%
1/26 • 24 months
|
|
Cardiac disorders
LV failure
|
7.4%
2/27 • 24 months
|
0.00%
0/26 • 24 months
|
|
General disorders
CVA
|
0.00%
0/27 • 24 months
|
3.8%
1/26 • 24 months
|
|
Nervous system disorders
Motor aphasia
|
0.00%
0/27 • 24 months
|
3.8%
1/26 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/27 • 24 months
|
3.8%
1/26 • 24 months
|
|
Cardiac disorders
Subclinical/Sub radiological ILD
|
3.7%
1/27 • 24 months
|
0.00%
0/26 • 24 months
|
|
Hepatobiliary disorders
Amiodarone induced liver injury
|
3.7%
1/27 • 24 months
|
0.00%
0/26 • 24 months
|
|
Hepatobiliary disorders
Hepatic enephalopathy
|
3.7%
1/27 • 24 months
|
0.00%
0/26 • 24 months
|
|
Cardiac disorders
Palpitations
|
3.7%
1/27 • 24 months
|
0.00%
0/26 • 24 months
|
Other adverse events
| Measure |
Amiodarone Only
n=27 participants at risk
Amiodarone is a Class III antiarrhythmic agent.
|
Amiodarone + Catheter Ablation
n=26 participants at risk
Amiodarone is a Class III antiarrhythmic agent.
Catheter VT Ablation: The ablation procedure uses radiofrequency energy to destroy cardiac tissue at the origin of the arrhythmia.
|
|---|---|---|
|
Cardiac disorders
Bradycardia
|
7.4%
2/27 • 24 months
|
11.5%
3/26 • 24 months
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/27 • 24 months
|
3.8%
1/26 • 24 months
|
|
Cardiac disorders
Transient AV block while crossing the Aortic Valve
|
0.00%
0/27 • 24 months
|
3.8%
1/26 • 24 months
|
|
General disorders
Chronic progressive gingivitis
|
0.00%
0/27 • 24 months
|
3.8%
1/26 • 24 months
|
|
Musculoskeletal and connective tissue disorders
right foot injury
|
0.00%
0/27 • 24 months
|
3.8%
1/26 • 24 months
|
|
Infections and infestations
Viral Pyrexia
|
0.00%
0/27 • 24 months
|
3.8%
1/26 • 24 months
|
|
Gastrointestinal disorders
Frequent loose stools
|
3.7%
1/27 • 24 months
|
0.00%
0/26 • 24 months
|
|
Psychiatric disorders
anxiety
|
3.7%
1/27 • 24 months
|
0.00%
0/26 • 24 months
|
|
Skin and subcutaneous tissue disorders
Right arm ecchymosis
|
3.7%
1/27 • 24 months
|
0.00%
0/26 • 24 months
|
Additional Information
Betsy Ellsworth, Research Program Director
Icahn School of Medicine at Mount Sinai
Phone: 212-824-8902
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place