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Effectiveness of Ripple Mapping in Atrial Tachycardia Ablation (RIPPLE-AT)

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ClinicalTrials.gov Identifier: NCT02451995
Recruitment Status : Completed
First Posted : May 22, 2015
Results First Posted : July 25, 2019
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Atrial Tachycardia
Interventions Device: Ripple Mapping guided AT ablation
Device: Local activation Time Mapping AT Ablation
Enrollment 105
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Ripple Mapping Guided AT Ablation Conventional Local Activation Time Mapping Ablation
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 42 41
Completed 42 41
Not Completed 0 0
Arm/Group Title Ripple Mapping Guided AT Ablation Conventional AT Ablation Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 42 41 83
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 41 participants 83 participants
65  (9) 65  (10) 65  (9)
Sex: Female, Male   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
Female 0
Male 0
[1]
Measure Description: Gender data not collected
[2]
Measure Analysis Population Description: Gender data not collected
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title A Composite of the Total Number of Participants With Either Tachycardia Change or Tachycardia Termination With First Ablation Set.
Hide Description 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.
Time Frame Participants will be followed for the duration of hospital stay (typically an overnight stay, hence 24hrs.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ripple Mapping Guided AT Ablation Conventional AT Ablation
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 42 41
Measure Type: Count of Participants
Unit of Measure: Participants
38
  90.5%
29
  70.7%
Time Frame 24hrs
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ripple Mapping Guided AT Ablation Conventional AT Ablation
Hide Arm/Group Description

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

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

All-Cause Mortality
Ripple Mapping Guided AT Ablation Conventional AT Ablation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)   0/41 (0.00%) 
Hide Serious Adverse Events
Ripple Mapping Guided AT Ablation Conventional AT Ablation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)   0/41 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ripple Mapping Guided AT Ablation Conventional AT Ablation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)   0/41 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Vishal Luther
Organization: Imperial College Healthcare
Phone: 07828913612
EMail: v.luther14@imperial.ac.uk
Layout table for additonal information
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02451995    
Other Study ID Numbers: 14HH2319
First Submitted: April 14, 2015
First Posted: May 22, 2015
Results First Submitted: May 14, 2019
Results First Posted: July 25, 2019
Last Update Posted: July 25, 2019