Ripple Mapping Guided Ablation of Ischaemic Ventricular Tachycardia. (RIPPLE-VT)

Ripple Mapping Guided Ablation of Ischaemic Ventricular Tachycardia: A Multi-centre Prospective Clinical Trial.

The Ripple VT-1 Study is a prospective clinical trial that aims to investigate if catheter ablation of ventricular tachycardia in patients with ischaemic heart disease can be effectively performed using Ripple Mapping.

Study Overview

• Status: Completed
• Conditions: Ischemic Heart Disease; Ventricular Tachycardia
• Intervention / Treatment: Procedure: Ripple Mapping guided ischaemic VT ablation

Detailed Description

Patients who have ischaemic heart disease and are at sufficient risk of, or have suffered, ventricular tachycardia may receive implantable cardioverter defibrillator (ICD) devices. ICD devices provide life-saving shocks to terminate ventricular tachycardia. There is however substantial evidence that correlates each life-saving shock with worsening prognosis.

Catheter ablation is a procedure that can treat the cause of ischaemic ventricular tachycardia (VT). Most catheter ablation procedures for ischaemic VT are performed in normal rhythm, with an end-point of arrhythmic substrate modification. Arrhythmic substrate modification refers to the process by which abnormal electrical activity in cardiac scar tissue (from ischaemic heart disease) is identified and treated by ablation.

Substrate modification catheter ablation procedures for ischaemic VT have been demonstrated to reduce ICD shocks and VT episodes in randomised trials compared to medications. However, ablation procedure outcomes are still imperfect with a recurrence rate of 50-60%.

Ripple Mapping is a method of mapping the hearts electrical signals, that may allow better identification of the abnormal activity within scar and so improve recurrence rates following ablation.

Patients referred for ablation of ischaemic VT, who have an ICD, will undergo their procedure with Ripple Mapping and subsequently followed up over a year, at 3 monthly intervals. The main assessed outcome will be ICD or VT events over a year. This will be compared to the number of ICD or VT events the year prior to ablation.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, W12 0HS
    • Hammersmith Hospital, Imperial College Healthcare NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with coronary artery disease and ischaemic cardiomyopathy requiring ICD implantation for primary or secondary prevention.
2. Any episode of VT detected or treated appropriately (within monitor zone or therapy (ATP/shock) delivered) or by 12 lead ECG if the rate below the detection level of the device. An episode of VT will be defined as lasting more than 30 secs or a regular high rate episode meeting VT criterion for >50% of the time before the first therapy is delivered (i.e. VT degenerating into VF is acceptable under these circumstances).
3. Ablation or medical therapy would be considered reasonable option for ongoing management.
4. Males or females 18 - 80 years of age.
5. Suitable candidate for catheter ablation.
6. Signed informed consent.

Exclusion Criteria:

1. Contraindication to catheter ablation.
2. VT due to reversible causes.
3. Severe valvular disease or ventricular thrombus.
4. Active gastrointestinal bleeding.
5. Serum Creatinine >200μmol/L or on dialysis.
6. Active fever or infection.
7. Life expectancy shorter than the duration of the trial.
8. Allergy to contrast.
9. Intractable heart failure (NYHA Class IV).
10. Bleeding or clotting disorders or inability to receive heparin.
11. Malignancy needing surgery, chemotherapy or radiotherapy.
12. Pregnancy or women of child-bearing potential not using a highly effective method of contraception.
13. Unable to attend follow-up visits or ICD clinics.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Ripple Mapping guided ischaemic VT ablation; Patients referred for ablation of ischaemic VT undergo Ripple Mapping guided procedure.	Procedure: Ripple Mapping guided ischaemic VT ablation; Endocardial mapping of the ventricle performed with Ripple Mapping (CARTO3v6, Biosense Webster Inc). Ablation (SmarTouch Thermocool Catheter, Biosense Webster Inc) delivered to areas of abnormal "late" electrical activity within ventricular scar tissue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Combined ICD Therapies and Mortality	ICD therapy (ATP and shocks) for sustained ventricular tachycardia or ventricular fibrillation as documented by the patients device. Device interrogations occur 3 monthly. Combined with Mortality (all-cause) by 1 year.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Achievement of the ablation procedure protocol end-point	Abolition of abnormal electrical activity within ischaemic ventricular scar by Ripple Mapping guided ablation	Procedure
Total ICD therapy rate	Total appropriate and inappropriate (defined as ICD therapies for reasons other than ventricular tachycardia/fibrillation) ICD therapies (ATP and shocks).	12 months
Total VT Episodes	Total VT Episodes, detected by the ICD device, occurring in the 12 months after ablation	12 months
Appropriate ATP therapy rate	Total appropriate ICD ATP therapies during 12 month follow up after ablation	12 months
Appropriate ICD Shocks rate	Total ICD Shocks during 12 month follow up after ablation	12 months
Repeat catheter ablation for ischaemic ventricular tachycardia	Need for a repeat catheter ablation procedure after the study procedure and during the 12 month follow up period.	12 months
All cause mortality	All cause mortality	12 months

Collaborators and Investigators

• Sponsor: Imperial College Healthcare NHS Trust
• Collaborators: Nottingham University Hospitals NHS Trust; Barts & The London NHS Trust; Hospital de Santa Maria, Portugal; Papworth Hospital NHS Foundation Trust; Newcastle-upon-Tyne Hospitals NHS Trust
• Investigators: Principal Investigator: Prapa Kanagaratnam, Imperial College Healthcare NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2019
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: June 24, 2019
• First Submitted That Met QC Criteria: June 24, 2019
• First Posted (Actual): June 25, 2019

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Ablation; Ventricular; Tachycardia; Mapping; Ischaemic
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Arrhythmias, Cardiac; Coronary Disease; Cardiac Conduction System Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Ischemia; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: 18SM4892

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No