NCT03997201

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 25, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

3 years

First QC Date

June 24, 2019

Last Update Submit

July 18, 2022

Conditions

Ventricular TachycardiaIschemic Heart Disease

Keywords

VentricularTachycardiaIschaemicMappingAblation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Achievement of the ablation procedure protocol end-point

    Procedure

  • Total ICD therapy rate

    12 months

  • Total VT Episodes

    12 months

  • Appropriate ATP therapy rate

    12 months

  • Appropriate ICD Shocks rate

    12 months

  • +2 more secondary outcomes

Study Arms (1)

Ripple Mapping guided ischaemic VT ablation

OTHER

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

Procedure: Ripple Mapping guided ischaemic VT ablation

Interventions

Ripple Mapping guided ischaemic VT ablationPROCEDURE

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.

Ripple Mapping guided ischaemic VT ablation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hammersmith Hospital, Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

Location

MeSH Terms

Conditions

Tachycardia, VentricularMyocardial IschemiaTachycardiaIschemia

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and SymptomsVascular Diseases

Study Officials

  • Prapa Kanagaratnam

    Imperial College Healthcare NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2019

First Posted

June 25, 2019

Study Start

April 18, 2019

Primary Completion

April 30, 2022

Study Completion

June 30, 2022

Last Updated

July 21, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)