Ripple Mapping Guided Ablation of Ischaemic Ventricular Tachycardia.

NCT ID: NCT03997201

Last Updated: 2022-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-18
• Study Completion Date: 2022-06-30

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.

Conditions

Ventricular Tachycardia; Ischemic Heart Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ripple Mapping guided ischaemic VT ablation

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

Group Type: OTHER

Ripple Mapping guided ischaemic VT ablation

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Barts & The London NHS Trust

OTHER

Sponsor Role: collaborator

Papworth Hospital NHS Foundation Trust

OTHER_GOV

Sponsor Role: collaborator

Nottingham University Hospitals NHS Trust

OTHER

Sponsor Role: collaborator

Newcastle-upon-Tyne Hospitals NHS Trust

OTHER

Sponsor Role: collaborator

Hospital de Santa Maria, Portugal

OTHER

Sponsor Role: collaborator

Imperial College Healthcare NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prapa Kanagaratnam

Role: PRINCIPAL_INVESTIGATOR

Imperial College Healthcare NHS Trust

Locations

Hammersmith Hospital, Imperial College Healthcare NHS Trust

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

18SM4892

Identifier Type: -

Identifier Source: org_study_id