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

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ClinicalTrials.gov Identifier: NCT03997201
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : June 25, 2019
Sponsor:
Collaborators:
Barts & The London NHS Trust
Papworth Hospital NHS Foundation Trust
Nottingham University Hospitals NHS Trust
Newcastle-upon-Tyne Hospitals NHS Trust
Hospital de Santa Maria, Portugal
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Ventricular Tachycardia Ischemic Heart Disease Procedure: Ripple Mapping guided ischaemic VT ablation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ripple Mapping Guided Ablation of Ischaemic Ventricular Tachycardia: A Multi-centre Prospective Clinical Trial.
Actual Study Start Date : April 18, 2019
Estimated Primary Completion Date : April 18, 2020
Estimated Study Completion Date : April 18, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Any appropriate ICD therapy [ Time Frame: 12 months ]
    ICD therapy (ATP and shocks) for sustained ventricular tachycardia or ventricular fibrillation.


Secondary Outcome Measures :
  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 ]
    Toral appropriate and inappropriate (defined as ICD therapies for reasons other than ventricular tachycardia/fibrillation) ICD therapies (ATP and shocks).

  3. All cause mortality [ Time Frame: 12 months ]
  4. Repeat catheter ablation for ischaemic ventricular tachycardia [ Time Frame: 12 months ]
  5. All cause hospitalisation [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997201


Contacts
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Contact: George Katritsis, MBChB 020 3313 1000 g.katritsis@ic.ac.uk
Contact: Prapa Kanagaratnam, MD, PhD 020 3313 1000 p.kanagaratnam@ic.ac.uk

Locations
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United Kingdom
Hammersmith Hospital, Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom, W12 0HS
Contact: George Katritsis, MBChB       g.katritsis@ic.ac.uk   
Contact: Prapa Kanagaratnam, MD, PhD       p.kanagaratnam@ic.ac.uk   
Sponsors and Collaborators
Imperial College Healthcare NHS Trust
Barts & The London NHS Trust
Papworth Hospital NHS Foundation Trust
Nottingham University Hospitals NHS Trust
Newcastle-upon-Tyne Hospitals NHS Trust
Hospital de Santa Maria, Portugal
Investigators
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Principal Investigator: Prapa Kanagaratnam Imperial College Healthcare NHS Trust

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Responsible Party: Imperial College Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT03997201     History of Changes
Other Study ID Numbers: 18SM4892
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Imperial College Healthcare NHS Trust:
Ventricular
Tachycardia
Ischaemic
Mapping
Ablation
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Ischemia
Pathologic Processes
Cardiovascular Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases