Trial Outcomes & Findings for Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation (NCT NCT04702451)
NCT ID: NCT04702451
Last Updated: 2025-09-12
Results Overview
Freedom from documented AF episodes \> 30 seconds, with or without anti-arrhythmic drugs (AADs), 12 months after a single index ablation procedure
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
377 participants
Primary outcome timeframe
12 months
Results posted on
2025-09-12
Participant Flow
Among the 377 patients enrolled, 3 patients did not receive any ablation, because their ablation was cancelled or postponed. They were therefore not randomized and exited the study.
Participant milestones
| Measure |
Tailored
Tailored ablation strategy
Dispersion ablation + PVI: Ablation of VX1-based spatio-temporal dispersion electrograms in combination with pulmonary vein antrum isolation
|
Anatomical
Anatomical ablation strategy
PVI: Pulmonary vein antrum isolation
|
|---|---|---|
|
Overall Study
STARTED
|
188
|
186
|
|
Overall Study
COMPLETED
|
174
|
174
|
|
Overall Study
NOT COMPLETED
|
14
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Tailored
n=187 Participants
Tailored ablation strategy
Dispersion ablation + PVI: Ablation of spatio-temporal dispersion electrograms in combination with pulmonary vein antrum isolation
VX1: VX1-based dispersion mapping
|
Anatomical
n=183 Participants
Anatomical ablation strategy
PVI: Pulmonary vein antrum isolation
|
Total
n=370 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.4 years
STANDARD_DEVIATION 8.5 • n=187 Participants
|
64.9 years
STANDARD_DEVIATION 8.5 • n=183 Participants
|
65.7 years
STANDARD_DEVIATION 8.5 • n=370 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=187 Participants
|
35 Participants
n=183 Participants
|
77 Participants
n=370 Participants
|
|
Sex: Female, Male
Male
|
145 Participants
n=187 Participants
|
148 Participants
n=183 Participants
|
293 Participants
n=370 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Netherlands
|
3 participants
n=187 Participants
|
2 participants
n=183 Participants
|
5 participants
n=370 Participants
|
|
Region of Enrollment
Belgium
|
6 participants
n=187 Participants
|
4 participants
n=183 Participants
|
10 participants
n=370 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=187 Participants
|
30 participants
n=183 Participants
|
59 participants
n=370 Participants
|
|
Region of Enrollment
France
|
128 participants
n=187 Participants
|
124 participants
n=183 Participants
|
252 participants
n=370 Participants
|
|
Region of Enrollment
Germany
|
21 participants
n=187 Participants
|
23 participants
n=183 Participants
|
44 participants
n=370 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: mITT: all randomized participants except for those who were deemed ineligible after randomization and before the ablation procedure, those who did not have any ablation procedure, and those lost to follow-up during the 3-month blanking period.
Freedom from documented AF episodes \> 30 seconds, with or without anti-arrhythmic drugs (AADs), 12 months after a single index ablation procedure
Outcome measures
| Measure |
Tailored
n=180 Participants
Tailored ablation strategy
Dispersion ablation + PVI: Ablation of spatio-temporal dispersion electrograms in combination with pulmonary vein antrum isolation
VX1: VX1-based dispersion mapping
|
Anatomical
n=177 Participants
Anatomical ablation strategy
PVI: Pulmonary vein antrum isolation
|
|---|---|---|
|
Number of Participants Free From Documented AF After One Ablation Procedure
|
158 Participants
|
124 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: mITT: all randomized participants except for those who were deemed ineligible after randomization and before the ablation procedure, those who did not have any ablation procedure, and those lost to follow-up during the 3-month blanking period.
Freedom from documented AF/AT episodes \> 30 seconds, after one or two procedures, with or without AADs, at 12 months
Outcome measures
| Measure |
Tailored
n=180 Participants
Tailored ablation strategy
Dispersion ablation + PVI: Ablation of spatio-temporal dispersion electrograms in combination with pulmonary vein antrum isolation
VX1: VX1-based dispersion mapping
|
Anatomical
n=177 Participants
Anatomical ablation strategy
PVI: Pulmonary vein antrum isolation
|
|---|---|---|
|
Number of Participants Free From Documented AF/AT After One or Two Ablation Procedures
|
136 Participants
|
126 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: mITT: all randomized participants except for those who were deemed ineligible after randomization and before the ablation procedure, those who did not have any ablation procedure, and those lost to follow-up during the 3-month blanking period.
Freedom from documented AF/AT episodes \> 30 seconds, with or without AADs, 12 months after a single ablation procedure
Outcome measures
| Measure |
Tailored
n=180 Participants
Tailored ablation strategy
Dispersion ablation + PVI: Ablation of spatio-temporal dispersion electrograms in combination with pulmonary vein antrum isolation
VX1: VX1-based dispersion mapping
|
Anatomical
n=177 Participants
Anatomical ablation strategy
PVI: Pulmonary vein antrum isolation
|
|---|---|---|
|
Number of Participants Free From Documented AF/AT After One Ablation Procedure
|
108 Participants
|
106 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The safety population included all randomized participants who underwent their first ablation procedure.
Complications at 12 months: death, cerebrovascular events, or serious treatment-related adverse event
Outcome measures
| Measure |
Tailored
n=187 Participants
Tailored ablation strategy
Dispersion ablation + PVI: Ablation of spatio-temporal dispersion electrograms in combination with pulmonary vein antrum isolation
VX1: VX1-based dispersion mapping
|
Anatomical
n=183 Participants
Anatomical ablation strategy
PVI: Pulmonary vein antrum isolation
|
|---|---|---|
|
Number of Participants With Complications (Safety Composite Endpoint)
|
8 Participants
|
5 Participants
|
Adverse Events
Tailored
Serious events: 21 serious events
Other events: 12 other events
Deaths: 2 deaths
Anatomical
Serious events: 11 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tailored
n=187 participants at risk
Tailored ablation strategy
Dispersion ablation + PVI: Ablation of spatio-temporal dispersion electrograms in combination with pulmonary vein antrum isolation
VX1: VX1-based dispersion mapping
|
Anatomical
n=183 participants at risk
Anatomical ablation strategy
PVI: Pulmonary vein antrum isolation
|
|---|---|---|
|
Cardiac disorders
Cardiac tamponade or perforation
|
1.1%
2/187 • Number of events 2 • 1 year after the study index ablation procedure
|
1.1%
2/183 • Number of events 2 • 1 year after the study index ablation procedure
|
|
Cardiac disorders
Bradycardia
|
0.53%
1/187 • Number of events 1 • 1 year after the study index ablation procedure
|
0.55%
1/183 • Number of events 1 • 1 year after the study index ablation procedure
|
|
Cardiac disorders
Severe cardiac decompensation
|
0.53%
1/187 • Number of events 1 • 1 year after the study index ablation procedure
|
0.55%
1/183 • Number of events 1 • 1 year after the study index ablation procedure
|
|
Vascular disorders
Puncture-site hemorrhage
|
0.00%
0/187 • 1 year after the study index ablation procedure
|
0.55%
1/183 • Number of events 1 • 1 year after the study index ablation procedure
|
|
Nervous system disorders
Transient phrenic nerve palsy
|
0.53%
1/187 • Number of events 1 • 1 year after the study index ablation procedure
|
0.00%
0/183 • 1 year after the study index ablation procedure
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/187 • 1 year after the study index ablation procedure
|
0.55%
1/183 • Number of events 1 • 1 year after the study index ablation procedure
|
|
Cardiac disorders
Fluid overload
|
4.8%
9/187 • Number of events 9 • 1 year after the study index ablation procedure
|
1.6%
3/183 • Number of events 3 • 1 year after the study index ablation procedure
|
|
Cardiac disorders
Pericarditis or pericardial effusion
|
2.1%
4/187 • Number of events 4 • 1 year after the study index ablation procedure
|
0.00%
0/183 • 1 year after the study index ablation procedure
|
|
Vascular disorders
Vascular access complications
|
1.6%
3/187 • Number of events 3 • 1 year after the study index ablation procedure
|
1.6%
3/183 • Number of events 3 • 1 year after the study index ablation procedure
|
|
Infections and infestations
Post-ablation fever
|
0.53%
1/187 • Number of events 1 • 1 year after the study index ablation procedure
|
0.00%
0/183 • 1 year after the study index ablation procedure
|
|
Cardiac disorders
Abnormal ECG requiring hospitalization
|
0.00%
0/187 • 1 year after the study index ablation procedure
|
0.55%
1/183 • Number of events 1 • 1 year after the study index ablation procedure
|
|
Nervous system disorders
Transient ischemic attack
|
0.53%
1/187 • Number of events 1 • 1 year after the study index ablation procedure
|
0.00%
0/183 • 1 year after the study index ablation procedure
|
Other adverse events
| Measure |
Tailored
n=187 participants at risk
Tailored ablation strategy
Dispersion ablation + PVI: Ablation of spatio-temporal dispersion electrograms in combination with pulmonary vein antrum isolation
VX1: VX1-based dispersion mapping
|
Anatomical
n=183 participants at risk
Anatomical ablation strategy
PVI: Pulmonary vein antrum isolation
|
|---|---|---|
|
Infections and infestations
Covid-19
|
6.4%
12/187 • Number of events 12 • 1 year after the study index ablation procedure
|
5.5%
10/183 • Number of events 10 • 1 year after the study index ablation procedure
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60