Ripple Mapping Guided Ablation of Ischaemic Ventricular Tachycardia.

Ischemic Heart Disease Clinical Trial

— RIPPLE-VT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03997201
• Other study ID #: 18SM4892
• Status: Completed
• Phase: N/A
• Start date: April 18, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2022
• Source: Imperial College Healthcare NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemia
• Ischemic Heart Disease
• Myocardial Ischemia
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Hammersmith Hospital, Imperial College Healthcare NHS Trust	London

Sponsors (6)

Lead Sponsor	Collaborator
Imperial College Healthcare NHS Trust	Barts & The London NHS Trust, Hospital de Santa Maria, Portugal, Newcastle-upon-Tyne Hospitals NHS Trust, Nottingham University Hospitals NHS Trust, Papworth Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Achievement of the ablation procedure protocol end-point	Abolition of abnormal electrical activity within ischaemic ventricular scar by Ripple Mapping guided ablation	Procedure
Secondary	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
Secondary	Total VT Episodes	Total VT Episodes, detected by the ICD device, occurring in the 12 months after ablation	12 months
Secondary	Appropriate ATP therapy rate	Total appropriate ICD ATP therapies during 12 month follow up after ablation	12 months
Secondary	Appropriate ICD Shocks rate	Total ICD Shocks during 12 month follow up after ablation	12 months
Secondary	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
Secondary	All cause mortality	All cause mortality	12 months