Effectiveness of Ripple Mapping in Atrial Tachycardia Ablation

NCT02451995 | Completed Results

• 1 other identifier: 14HH2319
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Tachycardia

Outcome Measures

Primary Outcomes (1)

• A Composite of the Total Number of Participants With Either Tachycardia Change or Tachycardia Termination With First Ablation Set.

  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.

  Participants will be followed for the duration of hospital stay (typically an overnight stay, hence 24hrs.

Study Arms (2)

Ripple Mapping guided AT ablation

EXPERIMENTAL

Ripple Mapping (Imperial College) software (Biosense Webster) will be used to diagnose the mechanism of AT and guide ablation

Device: Ripple Mapping guided AT ablation

Local activation Time Mapping AT Ablation

ACTIVE COMPARATOR

Standard activation mapping will be used to guide ablation.

Device: Local activation Time Mapping AT Ablation

Interventions

Ripple Mapping guided AT ablation DEVICE

Diagnosing the mechanism and delivering ablation within the atria in patients with atrial tachycardia on the basis of Ripple Mapping

Ripple Mapping guided AT ablation

Local activation Time Mapping AT Ablation DEVICE

Diagnosing the mechanism and delivering ablation within the atria in patients with atrial tachycardia on the basis of local activation time mapping

Local activation Time Mapping AT Ablation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. Patients with typical flutter.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Hammersmith Hospital, Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

Location

Related Publications (3)

• Linton NW, Koa-Wing M, Francis DP, Kojodjojo P, Lim PB, Salukhe TV, Whinnett Z, Davies DW, Peters NS, O'Neill MD, Kanagaratnam P. Cardiac ripple mapping: a novel three-dimensional visualization method for use with electroanatomic mapping of cardiac arrhythmias. Heart Rhythm. 2009 Dec;6(12):1754-62. doi: 10.1016/j.hrthm.2009.08.038. Epub 2009 Sep 3.

  PMID: 19959125 BACKGROUND

• Jamil-Copley S, Linton N, Koa-Wing M, Kojodjojo P, Lim PB, Malcolme-Lawes L, Whinnett Z, Wright I, Davies W, Peters N, Francis DP, Kanagaratnam P. Application of ripple mapping with an electroanatomic mapping system for diagnosis of atrial tachycardias. J Cardiovasc Electrophysiol. 2013 Dec;24(12):1361-9. doi: 10.1111/jce.12259. Epub 2013 Oct 10.

  PMID: 24118203 BACKGROUND

• Luther V, Agarwal S, Chow A, Koa-Wing M, Cortez-Dias N, Carpinteiro L, de Sousa J, Balasubramaniam R, Farwell D, Jamil-Copley S, Srinivasan N, Abbas H, Mason J, Jones N, Katritsis G, Lim PB, Peters NS, Qureshi N, Whinnett Z, Linton NWF, Kanagaratnam P. Ripple-AT Study: A Multicenter and Randomized Study Comparing 3D Mapping Techniques During Atrial Tachycardia Ablations. Circ Arrhythm Electrophysiol. 2019 Aug;12(8):e007394. doi: 10.1161/CIRCEP.118.007394. Epub 2019 Aug 9.

  PMID: 31394921 DERIVED

Results Point of Contact

• Title: Dr Vishal Luther
• Organization: Imperial College Healthcare

v.luther14@imperial.ac.uk

07828913612

Study Officials

• Prapa Kanagaratnam, MBBChir PhD

  Imperial College Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: May 22, 2015
• Study Start: June 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: July 25, 2019
• Results First Posted: July 25, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)