Trial Outcomes & Findings for Ectopy Triggering Ganglionated Plexus Ablation to Prevent Atrial Fibrillation (NCT NCT02487654)
NCT ID: NCT02487654
Last Updated: 2024-09-23
Results Overview
That is documented recurrent atrial arrhythmia lasting 30 seconds or more after a blanking period of 3 months; the outcome measure will be assessed up to 12 months of follow-up with 48hr halter monitors arranged every 3 months to investigate Arrhythmia recurrence .
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
116 participants
Primary outcome timeframe
3 to 12 months post-ablation.
Results posted on
2024-09-23
Participant Flow
The enrolement of participants was between 2017 and 2020
Participant milestones
| Measure |
Pulmonary Vein Isolation
Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation.
Pulmonary vein isolation: Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation.
|
Ganglionated Plexus Ablation
Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium
Ganglionated plexus ablation: Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
63
|
|
Overall Study
COMPLETED
|
50
|
52
|
|
Overall Study
NOT COMPLETED
|
3
|
11
|
Reasons for withdrawal
| Measure |
Pulmonary Vein Isolation
Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation.
Pulmonary vein isolation: Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation.
|
Ganglionated Plexus Ablation
Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium
Ganglionated plexus ablation: Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium
|
|---|---|---|
|
Overall Study
4 withdrawndue to non-identifiable GPs during HFS mapping in the GPA group.
|
0
|
4
|
|
Overall Study
Withdrawal by Subject
|
3
|
7
|
Baseline Characteristics
Ectopy Triggering Ganglionated Plexus Ablation to Prevent Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
Pulmonary Vein Isolation
n=50 Participants
Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation.
Pulmonary vein isolation: Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation.
|
Ganglionated Plexus Ablation
n=52 Participants
Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium
Ganglionated plexus ablation: Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 11 • n=5 Participants
|
64 years
STANDARD_DEVIATION 11 • n=7 Participants
|
63 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
50 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 to 12 months post-ablation.Population: Number of patients with no evidence of Atrial arrhythmia recurrence, \>30s, on a 48 hour Holter monitor during the initial 12 months post procedure
That is documented recurrent atrial arrhythmia lasting 30 seconds or more after a blanking period of 3 months; the outcome measure will be assessed up to 12 months of follow-up with 48hr halter monitors arranged every 3 months to investigate Arrhythmia recurrence .
Outcome measures
| Measure |
Pulmonary Vein Isolation
n=50 Participants
Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation.
Pulmonary vein isolation: Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation.
|
Ganglionated Plexus Ablation
n=52 Participants
Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium
Ganglionated plexus ablation: Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium
|
|---|---|---|
|
Number of Patients With no Evidence of >30s Recurrent Atrial Arrhythmia Post-index Procedure
|
32 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 3 to 12 months post-ablation.The reduction was defined as either a decrease of dose or a cessation of a drug over a 12 month follow-up period post ablation.
Outcome measures
| Measure |
Pulmonary Vein Isolation
n=50 Participants
Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation.
Pulmonary vein isolation: Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation.
|
Ganglionated Plexus Ablation
n=52 Participants
Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium
Ganglionated plexus ablation: Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium
|
|---|---|---|
|
Number of Participants Presenting a Reduction in the Usage of Antiarrhythmics Post-ablation
|
12 Participants
|
16 Participants
|
POST_HOC outcome
Timeframe: 40 months post procedure.evidence of \>30s atrial arrhythmia or symptoms consistent with arrhythmia recurrence, during routine clinical care, over an extended follow up period of 40 months.
Outcome measures
Outcome data not reported
Adverse Events
Pulmonary Vein Isolation
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Ganglionated Plexus Ablation
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pulmonary Vein Isolation
n=53 participants at risk
Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation.
Pulmonary vein isolation: Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation.
|
Ganglionated Plexus Ablation
n=63 participants at risk
Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium
Ganglionated plexus ablation: Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium
|
|---|---|---|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/53 • 12 months post procedure.
|
1.6%
1/63 • 12 months post procedure.
|
Other adverse events
| Measure |
Pulmonary Vein Isolation
n=53 participants at risk
Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation.
Pulmonary vein isolation: Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation.
|
Ganglionated Plexus Ablation
n=63 participants at risk
Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium
Ganglionated plexus ablation: Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium
|
|---|---|---|
|
Cardiac disorders
Pericarditis
|
1.9%
1/53 • Number of events 1 • 12 months post procedure.
|
11.1%
7/63 • Number of events 7 • 12 months post procedure.
|
Additional Information
Professor Prapa Kanagaratnam
Imperial College London
Phone: +44 20 3313 1000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place