Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 14, 2015
First Posted Date  ICMJE May 22, 2015
Results First Submitted Date  ICMJE May 14, 2019
Results First Posted Date  ICMJE July 25, 2019
Last Update Posted Date July 25, 2019
Study Start Date  ICMJE June 2015
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2015)
A Composite of the Total Number of Participants With Either Tachycardia Change or Tachycardia Termination With First Ablation Set. [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Ripple Mapping in Atrial Tachycardia Ablation
Official Title  ICMJE A Prospective Multi-centre Study of Effectiveness of Ripple Mapping for Atrial Tachycardia Ablation
Brief Summary

Tachycardia's (fast heart rhythms) can lead to troublesome palpitations, dizziness, blackouts and breathlessness. They are caused either by a cluster of abnormal cells within the heart, or an electrical short circuit which rotates rapidly around the heart. Sometimes these can be controlled with tablets, though owing to side effects many patients want something else. Many tachycardia's can be cured by a procedure known as an "ablation". In essence, either the focus of abnormal cells or the narrowest point of the short circuit causing the abnormal heart rhythm (the source) is electrically destroyed (burnt) resulting in restoration of the normal heart beat.

One form of tachycardia is known is Atrial Tachycardia (AT). These arise from the top two chambers of the heart (the atrium). Interestingly, this problem is frequently seen in patients who have previously undergone an ablation or surgical procedure for a condition called Atrial Fibrillation. In others the reason for its occurrence is unknown. Current strategies to find the "source" during an ablation procedure are technically challenging resulting in long procedure times. Sometimes the wrong source is found resulting in ablation at the incorrect site.

Ripple Mapping (RM) is a novel system that Investigators at Imperial College are looking to study. RM displays electrical information within the heart as a series of bars coming out of the chamber, with each bar representing signals travelling down the heart. By seeing the pattern of electrical information, they believe it will show the pattern of the tachycardia better than conventional techniques. In a previous retrospective study that they conducted, RM found the source of the tachycardia in 80% of the maps, compared to only 50% with the current system. Investigators at Imperial College have identified why they did not get 100% and they believe that, in future, RM will find the source of the tachycardia first time, and every time.

Detailed Description

Conventional mapping strategies used to find the "source" of "atrial tachycardia" within the heart are technically challenging resulting in long procedure times. Sometimes the wrong source is found resulting in ablation at the incorrect site.

In a retrospective study conducted by investigators at Imperial College, Ripple Mapping (RM) found the source of the tachycardia 80% of the time, compared to only 50% with conventional maps (known as local activation time maps). They have since studied the reasons why did not achieve 100%, but could not improve matters with a retrospective data-set. They believe that, in future, Ripple mapping will find the source of the tachycardia first time, and every time. The purpose of this study is to prospectively test whether Ripple Mapping is better at finding the source of the "atrial tachycardia" (AT) than conventional local activation time mapping.

Patients referred for clinically indicated AT ablation by their electro-physiologist will be recruited. For each patient recruited to the study, they will be block randomized into 2 arms: Ripple Mapping guided AT ablation, or Conventional AT guided Ablation (local activation time mapping). Following explanation of the study the patients will be allowed time to decide on whether they would like to participate.

Following completion of the consent procedure the patient will undergo the electrophysiology study as is routine standard practice. This is usually performed by inserting plastic tubes (catheters) into the heart using the vessels in the groin. Once the catheter is in the atrium (top chambers of the heart) the catheter will be moved to different locations in the chamber to gather the electrical information of the tissue. Using "CARTO3v4 ConfiDENSE", a 3-Dimensional map of the geometry of the heart chambers will be constructed.

Patient randomized to RM will proceed as follows: Once sufficient points have been collected, the Ripple Map will be played in order to diagnose the source of the tachycardia. In the context of a clear diagnosis, the operator can proceed to ablation at the defined source from the Ripple map. Termination of the tachycardia with ablation will be used to confirm the diagnosis was correct. A single entrainment is permissible where the diagnosis is unclear.

Patients randomized to conventional local activation time (LAT) mapping will proceed according to standard practice of the operator. When the operator is satisfied adequate number of points have been collected, the operator can proceed to ablation if the diagnosis is clear. A single entrainment is permissible where the diagnosis is unclear. The endpoints measured will include:

  1. Tachycardia change or termination following first series of ablations with Ripple Mapping vs local activation time mapping.
  2. The reliance on entrainment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atrial Tachycardia
Intervention  ICMJE
  • Device: 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
  • Device: Local activation Time Mapping AT Ablation
    Diagnosing the mechanism and delivering ablation within the atria in patients with atrial tachycardia on the basis of local activation time mapping
Study Arms  ICMJE
  • Experimental: Ripple Mapping guided AT ablation
    Ripple Mapping (Imperial College) software (Biosense Webster) will be used to diagnose the mechanism of AT and guide ablation
    Intervention: Device: Ripple Mapping guided AT ablation
  • Active Comparator: Local activation Time Mapping AT Ablation
    Standard activation mapping will be used to guide ablation.
    Intervention: Device: Local activation Time Mapping AT Ablation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2018)
105
Original Estimated Enrollment  ICMJE
 (submitted: May 19, 2015)
100
Actual Study Completion Date  ICMJE May 2018
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

1. Patients undergoing clinically indicated ablation for atrial tachycardia using 3D mapping.

Exclusion Criteria:

1. Patients with typical flutter.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02451995
Other Study ID Numbers  ICMJE 14HH2319
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Imperial College London
Study Sponsor  ICMJE Imperial College London
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Prapa Kanagaratnam, MBBChir PhD Imperial College Healthcare NHS Trust
PRS Account Imperial College London
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP