Trial Outcomes & Findings for AF Substrate Mapping and Guided Ablation (NCT NCT02571218)
NCT ID: NCT02571218
Last Updated: 2019-07-05
Results Overview
Freedom from symptomatic AF off antiarrhythmic drug therapy assessed from the end of the 3 months blanking period to 12 months following the ablation procedure, documented by implantable loop recorder (ILR) monitoring or trans-telephonic (TT) ECG monitoring.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
81 participants
Primary outcome timeframe
12 months
Results posted on
2019-07-05
Participant Flow
Participant milestones
| Measure |
mCPVA
Subjects in the mCPVA arm will undergo intervention called "modified circumferential pulmonary vein ablation", which is considered to be the standard ablation treatment for AF.
mCPVA: The intervention in the active comparator arm includes using the commercially available EnSite Velocity mapping and ablation system for modified circumferential pulmonary vein ablation.
|
Substrate+mCPVA
Subjects in the Substrate+mCPVA arm will undergo intervention of substrate mapping and substrate-targeted ablation guided by the investigational device, followed by completion of modified circumferential pulmonary vein ablation.
Substrate+mCPVA: The intervention in the experimental arm includes using a research software (investigational device) to map AF substrate and guide ablation.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
41
|
|
Overall Study
COMPLETED
|
40
|
41
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
AF Substrate Mapping and Guided Ablation
Baseline characteristics by cohort
| Measure |
mCPVA
n=40 Participants
Subjects in the mCPVA arm will undergo intervention called "modified circumferential pulmonary vein ablation", which is considered to be the standard ablation treatment for AF.
mCPVA: The intervention in the active comparator arm includes using the commercially available EnSite Velocity mapping and ablation system for modified circumferential pulmonary vein ablation.
|
Substrate+mCPVA
n=41 Participants
Subjects in the Substrate+mCPVA arm will undergo intervention of substrate mapping and substrate-targeted ablation guided by the investigational device, followed by completion of modified circumferential pulmonary vein ablation.
Substrate+mCPVA: The intervention in the experimental arm includes using a research software (investigational device) to map AF substrate and guide ablation.
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.5 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
63.5 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
61.7 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
40 participants
n=5 Participants
|
41 participants
n=7 Participants
|
81 participants
n=5 Participants
|
|
Hypertenstion, n
|
26 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Diabetes mellitus, n
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Years AF diagnosed, y
|
3.8 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
5.4 years
STANDARD_DEVIATION 5.3 • n=7 Participants
|
4.5 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
|
AF persistency, mo
|
6.5 months
STANDARD_DEVIATION 1.8 • n=5 Participants
|
5.8 months
STANDARD_DEVIATION 1.3 • n=7 Participants
|
6.1 months
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Left Ventricle Ejection Fraction (%)
|
53.5 %
STANDARD_DEVIATION 5.7 • n=5 Participants
|
55.5 %
STANDARD_DEVIATION 7.3 • n=7 Participants
|
54.6 %
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
LA area, cm2
|
24.8 cm2
STANDARD_DEVIATION 4.8 • n=5 Participants
|
24.5 cm2
STANDARD_DEVIATION 6.1 • n=7 Participants
|
24.5 cm2
STANDARD_DEVIATION 5.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Success rate of patient's undergoing radiofrequency catheter ablation during follow up.
Freedom from symptomatic AF off antiarrhythmic drug therapy assessed from the end of the 3 months blanking period to 12 months following the ablation procedure, documented by implantable loop recorder (ILR) monitoring or trans-telephonic (TT) ECG monitoring.
Outcome measures
| Measure |
mCPVA
n=40 Participants
Subjects in the mCPVA arm will undergo intervention called "modified circumferential pulmonary vein ablation", which is considered to be the standard ablation treatment for AF.
mCPVA: The intervention in the active comparator arm includes using the commercially available EnSite Velocity mapping and ablation system for modified circumferential pulmonary vein ablation.
|
Substrate+mCPVA
n=41 Participants
Subjects in the Substrate+mCPVA arm will undergo intervention of substrate mapping and substrate-targeted ablation guided by the investigational device, followed by completion of modified circumferential pulmonary vein ablation.
Substrate+mCPVA: The intervention in the experimental arm includes using a research software (investigational device) to map AF substrate and guide ablation.
|
|---|---|---|
|
Long-term Clinical Success Rate
|
30 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: During AblationPopulation: Success rate of radiofrequency catheter ablation to terminate atrial fibrillation during the ablation procedure.
Acute AF termination or significant AF cycle length slowing during RF application in ablation procedure
Outcome measures
| Measure |
mCPVA
n=40 Participants
Subjects in the mCPVA arm will undergo intervention called "modified circumferential pulmonary vein ablation", which is considered to be the standard ablation treatment for AF.
mCPVA: The intervention in the active comparator arm includes using the commercially available EnSite Velocity mapping and ablation system for modified circumferential pulmonary vein ablation.
|
Substrate+mCPVA
n=41 Participants
Subjects in the Substrate+mCPVA arm will undergo intervention of substrate mapping and substrate-targeted ablation guided by the investigational device, followed by completion of modified circumferential pulmonary vein ablation.
Substrate+mCPVA: The intervention in the experimental arm includes using a research software (investigational device) to map AF substrate and guide ablation.
|
|---|---|---|
|
Acute Ablation Procedure Outcome
|
12 Participants
|
25 Participants
|
Adverse Events
mCPVA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Substrate+mCPVA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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