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Completed

NCT Number: NCT03997201

Ripple Mapping Guided Ablation of Ischaemic Ventricular Tachycardia.

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hammersmith Hospital, Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with coronary artery disease and ischaemic cardiomyopathy requiring ICD implantation for primary or secondary prevention.
  • 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).
  • Ablation or medical therapy would be considered reasonable option for ongoing management.
  • Males or females 18 - 80 years of age.
  • Suitable candidate for catheter ablation.
  • Signed informed consent.

Exclusion criteria

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

Treatment and study plan

Ripple Mapping guided ischaemic VT ablation

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.

Primary outcomes

  1. Combined ICD Therapies and Mortality

    Time frame: 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 outcomes

  1. Achievement of the ablation procedure protocol end-point

    Time frame: Procedure

    Abolition of abnormal electrical activity within ischaemic ventricular scar by Ripple Mapping guided ablation

  2. Total ICD therapy rate

    Time frame: 12 months

    Total appropriate and inappropriate (defined as ICD therapies for reasons other than ventricular tachycardia/fibrillation) ICD therapies (ATP and shocks).

  3. Total VT Episodes

    Time frame: 12 months

    Total VT Episodes, detected by the ICD device, occurring in the 12 months after ablation

  4. Appropriate ATP therapy rate

    Time frame: 12 months

    Total appropriate ICD ATP therapies during 12 month follow up after ablation

  5. Appropriate ICD Shocks rate

    Time frame: 12 months

    Total ICD Shocks during 12 month follow up after ablation

  6. Repeat catheter ablation for ischaemic ventricular tachycardia

    Time frame: 12 months

    Need for a repeat catheter ablation procedure after the study procedure and during the 12 month follow up period.

  7. All cause mortality

    Time frame: 12 months

    All cause mortality

Sponsors and collaborators

Lead sponsor

Imperial College Healthcare NHS Trust

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: RIPPLE-VT

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 25, 2019
Registry last updated
Jul 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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