Trial Outcomes & Findings for Pan-Asia United States PrEvention of Sudden Cardiac Death Catheter Ablation Trial (NCT NCT02848781)
NCT ID: NCT02848781
Last Updated: 2022-12-14
Results Overview
The primary endpoint is a composite.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
180 participants
Primary outcome timeframe
2 years
Results posted on
2022-12-14
Participant Flow
Not Applicable - no wash out or run-in periods.
Participant milestones
| Measure |
ICD With Ablation
Patient will receive an implantable cardioverter defibrillator (ICD) with catheter ablation and standard medical management.
Implantable Cardioverter Defibrillator (ICD): An ICD is a battery-powered device placed under the skin that keeps track of heart rate. Thin wires connect the ICD to the heart. If an abnormal heart rhythm is detected, the device will deliver an electric shock to restore a normal heartbeat.
Catheter Ablation: Catheter ablation is a procedure that uses radiofrequency energy to destroy a small area of heart tissue that is causing rapid and irregular heartbeats. Destroying this tissue helps restore the heart's regular rhythm.
|
ICD Only
Patient will receive an implantable cardioverter defibrillator (ICD) and standard medical management.
Implantable Cardioverter Defibrillator (ICD): An ICD is a battery-powered device placed under the skin that keeps track of heart rate. Thin wires connect the ICD to the heart. If an abnormal heart rhythm is detected, the device will deliver an electric shock to restore a normal heartbeat.
|
Ablation Only (Registry)
The registry will enroll patients who refuse an implantable cardioverter defibrillator (ICD) and are thus not randomized. This arm will assess the efficacy of catheter ablation in the absence of background ICD therapy.
Catheter Ablation: Catheter ablation is a procedure that uses radiofrequency energy to destroy a small area of heart tissue that is causing rapid and irregular heartbeats. Destroying this tissue helps restore the heart's regular rhythm.
|
|---|---|---|---|
|
Overall Study
STARTED
|
67
|
66
|
47
|
|
Overall Study
COMPLETED
|
60
|
61
|
47
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pan-Asia United States PrEvention of Sudden Cardiac Death Catheter Ablation Trial
Baseline characteristics by cohort
| Measure |
ICD With Ablation
n=60 Participants
Patient will receive an implantable cardioverter defibrillator (ICD) with catheter ablation and standard medical management.
Implantable Cardioverter Defibrillator (ICD): An ICD is a battery-powered device placed under the skin that keeps track of heart rate. Thin wires connect the ICD to the heart. If an abnormal heart rhythm is detected, the device will deliver an electric shock to restore a normal heartbeat.
Catheter Ablation: Catheter ablation is a procedure that uses radiofrequency energy to destroy a small area of heart tissue that is causing rapid and irregular heartbeats. Destroying this tissue helps restore the heart's regular rhythm.
|
ICD Only
n=61 Participants
Patient will receive an implantable cardioverter defibrillator (ICD) and standard medical management.
Implantable Cardioverter Defibrillator (ICD): An ICD is a battery-powered device placed under the skin that keeps track of heart rate. Thin wires connect the ICD to the heart. If an abnormal heart rhythm is detected, the device will deliver an electric shock to restore a normal heartbeat.
|
Ablation Only (Registry)
n=47 Participants
The registry will enroll patients who refuse an implantable cardioverter defibrillator (ICD) and are thus not randomized. This arm will assess the efficacy of catheter ablation in the absence of background ICD therapy.
Catheter Ablation: Catheter ablation is a procedure that uses radiofrequency energy to destroy a small area of heart tissue that is causing rapid and irregular heartbeats. Destroying this tissue helps restore the heart's regular rhythm.
|
Total
n=168 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
44 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
131 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
138 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
60 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
168 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
South Korea
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Region of Enrollment
China
|
50 participants
n=5 Participants
|
49 participants
n=7 Participants
|
47 participants
n=5 Participants
|
146 participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
0 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Region of Enrollment
Taiwan
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
0 participants
n=5 Participants
|
11 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 yearsThe primary endpoint is a composite.
Outcome measures
| Measure |
ICD With Ablation
n=60 Participants
Patient will receive an implantable cardioverter defibrillator (ICD) with catheter ablation and standard medical management.
Implantable Cardioverter Defibrillator (ICD): An ICD is a battery-powered device placed under the skin that keeps track of heart rate. Thin wires connect the ICD to the heart. If an abnormal heart rhythm is detected, the device will deliver an electric shock to restore a normal heartbeat.
Catheter Ablation: Catheter ablation is a procedure that uses radiofrequency energy to destroy a small area of heart tissue that is causing rapid and irregular heartbeats. Destroying this tissue helps restore the heart's regular rhythm.
|
ICD Only
n=61 Participants
Patient will receive an implantable cardioverter defibrillator (ICD) and standard medical management.
Implantable Cardioverter Defibrillator (ICD): An ICD is a battery-powered device placed under the skin that keeps track of heart rate. Thin wires connect the ICD to the heart. If an abnormal heart rhythm is detected, the device will deliver an electric shock to restore a normal heartbeat.
|
Ablation Only (Registry)
n=47 Participants
The registry will enroll patients who refuse an implantable cardioverter defibrillator (ICD) and are thus not randomized. This arm will assess the efficacy of catheter ablation in the absence of background ICD therapy.
Catheter Ablation: Catheter ablation is a procedure that uses radiofrequency energy to destroy a small area of heart tissue that is causing rapid and irregular heartbeats. Destroying this tissue helps restore the heart's regular rhythm.
|
|---|---|---|---|
|
Freedom From Recurrent VT, Cardiovascular Rehospitalization, and All-cause Mortality
Freedom from recurrent VT, cardiovascular rehospitalization, and all-cause mortality
|
33 Participants
|
25 Participants
|
28 Participants
|
|
Freedom From Recurrent VT, Cardiovascular Rehospitalization, and All-cause Mortality
Recurrent VT, cardiovascular rehospitalization, and all-cause mortality
|
27 Participants
|
36 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 2 yearsRecurrent VT is defined as any appropriate ICD therapy (shock or ATP) or documented sustained monomorphic VT \>30 seconds.
Outcome measures
| Measure |
ICD With Ablation
n=60 Participants
Patient will receive an implantable cardioverter defibrillator (ICD) with catheter ablation and standard medical management.
Implantable Cardioverter Defibrillator (ICD): An ICD is a battery-powered device placed under the skin that keeps track of heart rate. Thin wires connect the ICD to the heart. If an abnormal heart rhythm is detected, the device will deliver an electric shock to restore a normal heartbeat.
Catheter Ablation: Catheter ablation is a procedure that uses radiofrequency energy to destroy a small area of heart tissue that is causing rapid and irregular heartbeats. Destroying this tissue helps restore the heart's regular rhythm.
|
ICD Only
n=61 Participants
Patient will receive an implantable cardioverter defibrillator (ICD) and standard medical management.
Implantable Cardioverter Defibrillator (ICD): An ICD is a battery-powered device placed under the skin that keeps track of heart rate. Thin wires connect the ICD to the heart. If an abnormal heart rhythm is detected, the device will deliver an electric shock to restore a normal heartbeat.
|
Ablation Only (Registry)
n=47 Participants
The registry will enroll patients who refuse an implantable cardioverter defibrillator (ICD) and are thus not randomized. This arm will assess the efficacy of catheter ablation in the absence of background ICD therapy.
Catheter Ablation: Catheter ablation is a procedure that uses radiofrequency energy to destroy a small area of heart tissue that is causing rapid and irregular heartbeats. Destroying this tissue helps restore the heart's regular rhythm.
|
|---|---|---|---|
|
Freedom From Recurrent VT
Freedom from recurrent VT
|
41 Participants
|
30 Participants
|
32 Participants
|
|
Freedom From Recurrent VT
Experienced recurrent VT
|
19 Participants
|
31 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 2 yearsCardiovascular rehospitalization is defined as a hospital admission after the randomized procedure for heart failure, procedure-associated complication, or arrhythmia-related causes during the follow-up period.
Outcome measures
| Measure |
ICD With Ablation
n=60 Participants
Patient will receive an implantable cardioverter defibrillator (ICD) with catheter ablation and standard medical management.
Implantable Cardioverter Defibrillator (ICD): An ICD is a battery-powered device placed under the skin that keeps track of heart rate. Thin wires connect the ICD to the heart. If an abnormal heart rhythm is detected, the device will deliver an electric shock to restore a normal heartbeat.
Catheter Ablation: Catheter ablation is a procedure that uses radiofrequency energy to destroy a small area of heart tissue that is causing rapid and irregular heartbeats. Destroying this tissue helps restore the heart's regular rhythm.
|
ICD Only
n=61 Participants
Patient will receive an implantable cardioverter defibrillator (ICD) and standard medical management.
Implantable Cardioverter Defibrillator (ICD): An ICD is a battery-powered device placed under the skin that keeps track of heart rate. Thin wires connect the ICD to the heart. If an abnormal heart rhythm is detected, the device will deliver an electric shock to restore a normal heartbeat.
|
Ablation Only (Registry)
n=47 Participants
The registry will enroll patients who refuse an implantable cardioverter defibrillator (ICD) and are thus not randomized. This arm will assess the efficacy of catheter ablation in the absence of background ICD therapy.
Catheter Ablation: Catheter ablation is a procedure that uses radiofrequency energy to destroy a small area of heart tissue that is causing rapid and irregular heartbeats. Destroying this tissue helps restore the heart's regular rhythm.
|
|---|---|---|---|
|
Freedom From Cardiovascular Rehospitalization
Freedom from cardiovascular rehospitalization
|
43 Participants
|
41 Participants
|
35 Participants
|
|
Freedom From Cardiovascular Rehospitalization
Experienced cardiovascular rehospitalization
|
17 Participants
|
20 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
ICD With Ablation
n=60 Participants
Patient will receive an implantable cardioverter defibrillator (ICD) with catheter ablation and standard medical management.
Implantable Cardioverter Defibrillator (ICD): An ICD is a battery-powered device placed under the skin that keeps track of heart rate. Thin wires connect the ICD to the heart. If an abnormal heart rhythm is detected, the device will deliver an electric shock to restore a normal heartbeat.
Catheter Ablation: Catheter ablation is a procedure that uses radiofrequency energy to destroy a small area of heart tissue that is causing rapid and irregular heartbeats. Destroying this tissue helps restore the heart's regular rhythm.
|
ICD Only
n=61 Participants
Patient will receive an implantable cardioverter defibrillator (ICD) and standard medical management.
Implantable Cardioverter Defibrillator (ICD): An ICD is a battery-powered device placed under the skin that keeps track of heart rate. Thin wires connect the ICD to the heart. If an abnormal heart rhythm is detected, the device will deliver an electric shock to restore a normal heartbeat.
|
Ablation Only (Registry)
n=47 Participants
The registry will enroll patients who refuse an implantable cardioverter defibrillator (ICD) and are thus not randomized. This arm will assess the efficacy of catheter ablation in the absence of background ICD therapy.
Catheter Ablation: Catheter ablation is a procedure that uses radiofrequency energy to destroy a small area of heart tissue that is causing rapid and irregular heartbeats. Destroying this tissue helps restore the heart's regular rhythm.
|
|---|---|---|---|
|
Freedom From All-cause Mortality
Freedom from all-cause mortality
|
55 Participants
|
57 Participants
|
44 Participants
|
|
Freedom From All-cause Mortality
Experienced all-cause mortality
|
5 Participants
|
4 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsOutcome measures
| Measure |
ICD With Ablation
n=121 Participants
Patient will receive an implantable cardioverter defibrillator (ICD) with catheter ablation and standard medical management.
Implantable Cardioverter Defibrillator (ICD): An ICD is a battery-powered device placed under the skin that keeps track of heart rate. Thin wires connect the ICD to the heart. If an abnormal heart rhythm is detected, the device will deliver an electric shock to restore a normal heartbeat.
Catheter Ablation: Catheter ablation is a procedure that uses radiofrequency energy to destroy a small area of heart tissue that is causing rapid and irregular heartbeats. Destroying this tissue helps restore the heart's regular rhythm.
|
ICD Only
n=47 Participants
Patient will receive an implantable cardioverter defibrillator (ICD) and standard medical management.
Implantable Cardioverter Defibrillator (ICD): An ICD is a battery-powered device placed under the skin that keeps track of heart rate. Thin wires connect the ICD to the heart. If an abnormal heart rhythm is detected, the device will deliver an electric shock to restore a normal heartbeat.
|
Ablation Only (Registry)
The registry will enroll patients who refuse an implantable cardioverter defibrillator (ICD) and are thus not randomized. This arm will assess the efficacy of catheter ablation in the absence of background ICD therapy.
Catheter Ablation: Catheter ablation is a procedure that uses radiofrequency energy to destroy a small area of heart tissue that is causing rapid and irregular heartbeats. Destroying this tissue helps restore the heart's regular rhythm.
|
|---|---|---|---|
|
Comparison of Outcomes in Ablation Only Registry With Randomized Patients
Cardiovascular Rehospitalization
|
37 participants
|
12 participants
|
—
|
|
Comparison of Outcomes in Ablation Only Registry With Randomized Patients
Recurrence of VT
|
50 participants
|
15 participants
|
—
|
|
Comparison of Outcomes in Ablation Only Registry With Randomized Patients
All-Cause Mortality
|
9 participants
|
3 participants
|
—
|
Adverse Events
ICD With Ablation
Serious events: 20 serious events
Other events: 19 other events
Deaths: 5 deaths
ICD Only
Serious events: 20 serious events
Other events: 31 other events
Deaths: 4 deaths
Ablation Only (Registry)
Serious events: 15 serious events
Other events: 15 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
ICD With Ablation
n=60 participants at risk
Patient will receive an implantable cardioverter defibrillator (ICD) with catheter ablation and standard medical management.
Implantable Cardioverter Defibrillator (ICD): An ICD is a battery-powered device placed under the skin that keeps track of heart rate. Thin wires connect the ICD to the heart. If an abnormal heart rhythm is detected, the device will deliver an electric shock to restore a normal heartbeat.
Catheter Ablation: Catheter ablation is a procedure that uses radiofrequency energy to destroy a small area of heart tissue that is causing rapid and irregular heartbeats. Destroying this tissue helps restore the heart's regular rhythm.
|
ICD Only
n=61 participants at risk
Patient will receive an implantable cardioverter defibrillator (ICD) and standard medical management.
Implantable Cardioverter Defibrillator (ICD): An ICD is a battery-powered device placed under the skin that keeps track of heart rate. Thin wires connect the ICD to the heart. If an abnormal heart rhythm is detected, the device will deliver an electric shock to restore a normal heartbeat.
|
Ablation Only (Registry)
n=47 participants at risk
The registry will enroll patients who refuse an implantable cardioverter defibrillator (ICD) and are thus not randomized. This arm will assess the efficacy of catheter ablation in the absence of background ICD therapy.
Catheter Ablation: Catheter ablation is a procedure that uses radiofrequency energy to destroy a small area of heart tissue that is causing rapid and irregular heartbeats. Destroying this tissue helps restore the heart's regular rhythm.
|
|---|---|---|---|
|
Cardiac disorders
Procedure Complication
|
8.3%
5/60 • Subjects were followed for a mean of 2 years, and up to a maximum of 5 years.
|
0.00%
0/61 • Subjects were followed for a mean of 2 years, and up to a maximum of 5 years.
|
2.1%
1/47 • Subjects were followed for a mean of 2 years, and up to a maximum of 5 years.
|
|
Cardiac disorders
Rehospitalization
|
28.3%
17/60 • Subjects were followed for a mean of 2 years, and up to a maximum of 5 years.
|
32.8%
20/61 • Subjects were followed for a mean of 2 years, and up to a maximum of 5 years.
|
25.5%
12/47 • Subjects were followed for a mean of 2 years, and up to a maximum of 5 years.
|
|
Cardiac disorders
Mortality
|
8.3%
5/60 • Subjects were followed for a mean of 2 years, and up to a maximum of 5 years.
|
6.6%
4/61 • Subjects were followed for a mean of 2 years, and up to a maximum of 5 years.
|
6.4%
3/47 • Subjects were followed for a mean of 2 years, and up to a maximum of 5 years.
|
Other adverse events
| Measure |
ICD With Ablation
n=60 participants at risk
Patient will receive an implantable cardioverter defibrillator (ICD) with catheter ablation and standard medical management.
Implantable Cardioverter Defibrillator (ICD): An ICD is a battery-powered device placed under the skin that keeps track of heart rate. Thin wires connect the ICD to the heart. If an abnormal heart rhythm is detected, the device will deliver an electric shock to restore a normal heartbeat.
Catheter Ablation: Catheter ablation is a procedure that uses radiofrequency energy to destroy a small area of heart tissue that is causing rapid and irregular heartbeats. Destroying this tissue helps restore the heart's regular rhythm.
|
ICD Only
n=61 participants at risk
Patient will receive an implantable cardioverter defibrillator (ICD) and standard medical management.
Implantable Cardioverter Defibrillator (ICD): An ICD is a battery-powered device placed under the skin that keeps track of heart rate. Thin wires connect the ICD to the heart. If an abnormal heart rhythm is detected, the device will deliver an electric shock to restore a normal heartbeat.
|
Ablation Only (Registry)
n=47 participants at risk
The registry will enroll patients who refuse an implantable cardioverter defibrillator (ICD) and are thus not randomized. This arm will assess the efficacy of catheter ablation in the absence of background ICD therapy.
Catheter Ablation: Catheter ablation is a procedure that uses radiofrequency energy to destroy a small area of heart tissue that is causing rapid and irregular heartbeats. Destroying this tissue helps restore the heart's regular rhythm.
|
|---|---|---|---|
|
Cardiac disorders
Arrhythmia, Palpitation
|
31.7%
19/60 • Subjects were followed for a mean of 2 years, and up to a maximum of 5 years.
|
50.8%
31/61 • Subjects were followed for a mean of 2 years, and up to a maximum of 5 years.
|
31.9%
15/47 • Subjects were followed for a mean of 2 years, and up to a maximum of 5 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place