Trial Outcomes & Findings for Catheter Ablation vs. Medical Therapy in Congested Hearts With AF (NCT NCT02686749)
NCT ID: NCT02686749
Last Updated: 2025-06-05
Results Overview
Time measured in days to first hospitalization for heart failure, recurrence of AF or Direct Current cardioversion after the treatment period (first 3 months post enrollment or post procedure during which repeat ablation can be performed and titration of AADs can be performed).
TERMINATED
PHASE4
4 participants
12 months
2025-06-05
Participant Flow
Participant milestones
| Measure |
AF Catheter Ablation
Pulmonary Vein Isolation catheter ablation for treatment of AF. AF catheter ablation is an FDA approved treatment for AF
Catheter Ablation: During ablation, a doctor inserts a catheter through blood vessels into the heart. The doctor looks at the electrical activity of the heart. The catheter is used to determine which areas of the heart are causing AF. After the area is identified, the doctor uses a special machine delivers energy through the catheter to tiny areas of the heart muscle that is causing AF. This energy causes a scar in the tissue which "disconnects" the pathway of the AF.
|
FDA Approved Anti Arrhythmic Drug
FDA approved anti arrhythmic drug for the treatment of AF will be based on treating physicians' preference in accordance to guidelines.
FDA approved anti arrhythmic drug: Anti arrhythmic drug medical treatment will be based on treating physicians discretion following standard clinical guidelines
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
AF Catheter Ablation
Pulmonary Vein Isolation catheter ablation for treatment of AF. AF catheter ablation is an FDA approved treatment for AF
Catheter Ablation: During ablation, a doctor inserts a catheter through blood vessels into the heart. The doctor looks at the electrical activity of the heart. The catheter is used to determine which areas of the heart are causing AF. After the area is identified, the doctor uses a special machine delivers energy through the catheter to tiny areas of the heart muscle that is causing AF. This energy causes a scar in the tissue which "disconnects" the pathway of the AF.
|
FDA Approved Anti Arrhythmic Drug
FDA approved anti arrhythmic drug for the treatment of AF will be based on treating physicians' preference in accordance to guidelines.
FDA approved anti arrhythmic drug: Anti arrhythmic drug medical treatment will be based on treating physicians discretion following standard clinical guidelines
|
|---|---|---|
|
Overall Study
terminated for poor enrollment
|
2
|
2
|
Baseline Characteristics
Trial terminated due to poor enrollment. No subjects completed study. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
Baseline characteristics by cohort
| Measure |
AF Catheter Ablation
n=2 Participants
Pulmonary Vein Isolation catheter ablation for treatment of AF. AF catheter ablation is an FDA approved treatment for AF
Catheter Ablation: During ablation, a doctor inserts a catheter through blood vessels into the heart. The doctor looks at the electrical activity of the heart. The catheter is used to determine which areas of the heart are causing AF. After the area is identified, the doctor uses a special machine delivers energy through the catheter to tiny areas of the heart muscle that is causing AF. This energy causes a scar in the tissue which "disconnects" the pathway of the AF.
|
FDA Approved Anti Arrhythmic Drug
n=2 Participants
FDA approved anti arrhythmic drug for the treatment of AF will be based on treating physicians' preference in accordance to guidelines.
FDA approved anti arrhythmic drug: Anti arrhythmic drug medical treatment will be based on treating physicians discretion following standard clinical guidelines
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants • Trial terminated due to poor enrollment. No subjects completed study. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
|
0 Participants
n=2 Participants • Trial terminated due to poor enrollment. No subjects completed study. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
|
0 Participants
n=4 Participants • Trial terminated due to poor enrollment. No subjects completed study. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=2 Participants • Trial terminated due to poor enrollment. No subjects completed study. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
|
0 Participants
n=2 Participants • Trial terminated due to poor enrollment. No subjects completed study. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
|
2 Participants
n=4 Participants • Trial terminated due to poor enrollment. No subjects completed study. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=2 Participants • Trial terminated due to poor enrollment. No subjects completed study. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
|
2 Participants
n=2 Participants • Trial terminated due to poor enrollment. No subjects completed study. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
|
2 Participants
n=4 Participants • Trial terminated due to poor enrollment. No subjects completed study. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
|
|
Sex: Female, Male
Female
|
0 Participants
Trial terminated due to poor enrollment. No subjects completed study. No data analyzed. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
|
0 Participants
Trial terminated due to poor enrollment. No subjects completed study. No data analyzed. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
|
0 Participants
Trial terminated due to poor enrollment. No subjects completed study. No data analyzed. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
|
|
Sex: Female, Male
Male
|
0 Participants
Trial terminated due to poor enrollment. No subjects completed study. No data analyzed. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
|
0 Participants
Trial terminated due to poor enrollment. No subjects completed study. No data analyzed. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
|
0 Participants
Trial terminated due to poor enrollment. No subjects completed study. No data analyzed. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Trial terminated due to poor enrollment. No subjects completed study. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
Time measured in days to first hospitalization for heart failure, recurrence of AF or Direct Current cardioversion after the treatment period (first 3 months post enrollment or post procedure during which repeat ablation can be performed and titration of AADs can be performed).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 15 monthsPopulation: Trial terminated due to poor enrollment. No subjects completed study. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
total number of cardiovascular hospitalization measured by hospitalization admissions
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 15 monthsPopulation: Trial terminated due to poor enrollment. No subjects completed study. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
time measured in days to recurrence of AF lasting longer than 30 seconds
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months through 15 monthsPopulation: Trial terminated due to poor enrollment. No subjects completed study. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
change in distance walked in 6 mile walk test
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months through 15 monthsPopulation: Trial terminated due to poor enrollment. No subjects completed study. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
change in the Rand 36-Item Health Survey reflective of change in patient's quality of life
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline through15 monthsPopulation: Trial terminated due to poor enrollment. No subjects completed study. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
Change in Ejection Fraction heart failure measurement (percentage)
Outcome measures
Outcome data not reported
Adverse Events
AF Catheter Ablation
FDA Approved Anti Arrhythmic Drug
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place