Trial Outcomes & Findings for Effectiveness of Ripple Mapping in Atrial Tachycardia Ablation (NCT NCT02451995)
NCT ID: NCT02451995
Last Updated: 2019-07-25
Results Overview
The total number of participants in each arm with either a change of termination of their atrial tachycardia following delivery of the first ablation set post map categorisation.
COMPLETED
NA
105 participants
Participants will be followed for the duration of hospital stay (typically an overnight stay, hence 24hrs.
2019-07-25
Participant Flow
22 were excluded. This was due premature termination of AT whilst mapping (n=6), AT non-inducibility (n=9), or degeneration to alternating ATs/atrial fibrillation prior to the delivery of ablation (n=4). Left atrial appendage thrombus on Trans Oesophageal Echo seen at the start of the procedure (n=3) resulted in immediate procedural cessation.
Participant milestones
| Measure |
Ripple Mapping Guided AT Ablation
Ripple Mapping (Imperial College) software (Biosense Webster) will be used to diagnose the mechanism of AT and guide ablation
Ripple Mapping guided AT ablation: Diagnosing the mechanism and delivering ablation within the atria in patients with atrial tachycardia on the basis of Ripple Mapping
|
Conventional Local Activation Time Mapping Ablation
Standard activation mapping will be used to guide ablation.
Conventional AT ablation: Diagnosing the mechanism and delivering ablation within the atria in patients with atrial tachycardia on the basis of activation mapping
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
41
|
|
Overall Study
COMPLETED
|
42
|
41
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gender data not collected
Baseline characteristics by cohort
| Measure |
Ripple Mapping Guided AT Ablation
n=42 Participants
Ripple Mapping (Imperial College) software (Biosense Webster) will be used to diagnose the mechanism of AT and guide ablation
Ripple Mapping guided AT ablation: Diagnosing the mechanism and delivering ablation within the atria in patients with atrial tachycardia on the basis of Ripple Mapping
|
Conventional AT Ablation
n=41 Participants
Standard activation mapping and entrainment will be used to guide ablation.
Conventional AT ablation: Diagnosing the mechanism and delivering ablation within the atria in patients with atrial tachycardia on the basis of activation mapping and entrainment
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 9 • n=42 Participants
|
65 years
STANDARD_DEVIATION 10 • n=41 Participants
|
65 years
STANDARD_DEVIATION 9 • n=83 Participants
|
|
Sex: Female, Male
Female
|
—
|
—
|
0 Participants
Gender data not collected
|
|
Sex: Female, Male
Male
|
—
|
—
|
0 Participants
Gender data not collected
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Participants will be followed for the duration of hospital stay (typically an overnight stay, hence 24hrs.The total number of participants in each arm with either a change of termination of their atrial tachycardia following delivery of the first ablation set post map categorisation.
Outcome measures
| Measure |
Ripple Mapping Guided AT Ablation
n=42 Participants
Ripple Mapping (Imperial College) software (Biosense Webster) will be used to diagnose the mechanism of AT and guide ablation
Ripple Mapping guided AT ablation: Diagnosing the mechanism and delivering ablation within the atria in patients with atrial tachycardia on the basis of Ripple Mapping
|
Conventional AT Ablation
n=41 Participants
Standard activation mapping will be used to guide ablation.
Conventional AT ablation: Diagnosing the mechanism and delivering ablation within the atria in patients with atrial tachycardia on the basis of activation mapping
|
|---|---|---|
|
A Composite of the Total Number of Participants With Either Tachycardia Change or Tachycardia Termination With First Ablation Set.
|
38 Participants
|
29 Participants
|
Adverse Events
Ripple Mapping Guided AT Ablation
Conventional AT Ablation
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