Ripple Mapping Guided Ablation of Ischaemic Ventricular Tachycardia.

Not Applicable

Completed

• Conditions: Ventricular Tachycardia; Ischemic Heart Disease
• Interventions: Procedure: Ripple Mapping guided ischaemic VT ablation

• Registration Number: NCT03997201
• Lead Sponsor: Imperial College Healthcare NHS Trust

Brief Summary

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.

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 Timeline

• Study Start: 2019-04-18
• Study First Submitted: 2019-06-24
• Study First Submitted QC: 2019-06-24
• Study First Posted: 2019-06-25
• Primary Completion: 2022-04-30
• Study Completion: 2022-06-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ripple Mapping guided ischaemic VT ablation	Ripple Mapping guided ischaemic VT ablation	Patients referred for ablation of ischaemic VT undergo Ripple Mapping guided procedure.

Primary Outcome Measures

Name	Time	Method
Combined ICD Therapies and Mortality	12 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hammersmith Hospital, Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom