Ventricular TachycardiaRIPPLE-VTNCT03997201
Ripple Mapping Guided Ablation of Ischaemic Ventricular Tachycardia.
A study testing Ripple Mapping guided ischaemic VT ablation in people with Ventricular Tachycardia and Ischemic Heart Disease, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventricular Tachycardia, Ischemic Heart Disease
- What is being tested?
- Ripple Mapping guided ischaemic VT ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Apr 2019to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hammersmith Hospital, Imperial College Healthcare NHS Trust
London, W12 0HS
About this study
Official title: Ripple Mapping Guided Ablation of Ischaemic Ventricular Tachycardia: A Multi-centre Prospective Clinical Trial.
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.
Read the 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
- Being tested
- Ripple Mapping guided ischaemic VT ablation
- Keywords
- Ventricular, Tachycardia, Ischaemic, Mapping, Ablation
- Medical subject headings
- Tachycardia, Ventricular, Myocardial Ischemia, Tachycardia, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ripple Mapping guided ischaemic VT ablationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Ripple Mapping guided ischaemic VT ablation | Other | Patients referred for ablation of ischaemic VT undergo Ripple Mapping guided procedure. Receives: Procedure: Ripple Mapping guided ischaemic VT ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (7)
Achievement of the ablation procedure protocol end-point
Abolition of abnormal electrical activity within ischaemic ventricular scar by Ripple Mapping guided ablation
Measured: Procedure
Total ICD therapy rate
Total appropriate and inappropriate (defined as ICD therapies for reasons other than ventricular tachycardia/fibrillation) ICD therapies (ATP and shocks).
Measured: 12 months
Total VT Episodes
Total VT Episodes, detected by the ICD device, occurring in the 12 months after ablation
Measured: 12 months
Appropriate ATP therapy rate
Total appropriate ICD ATP therapies during 12 month follow up after ablation
Measured: 12 months
Appropriate ICD Shocks rate
Total ICD Shocks during 12 month follow up after ablation
Measured: 12 months
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.
Measured: 12 months
All cause mortality
All cause mortality
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start18 Apr 2019
- Primary completion30 Apr 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective clinical trial
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Prapa Kanagaratnam, Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997201
- Sponsor's protocol ID
- 18SM4892
- Acronym
- RIPPLE-VT
- Status last verified
- Jul 2022
- First submitted
- 24 Jun 2019
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Katritsis G, Kailey B, Jamil-Copley S, Luther V, Koa-Wing M, Cortez-Dias N, Carpinteiro L, de Sousa J, Martin R, Murray S, Das M, Whinnett Z, Lim PB, Peters NS, Ng FS, Chow AW, Linton NWF, Kanagaratnam P. RIPPLE-VT study: Multicenter prospective evaluation of ventricular tachycardia substrate ablation by targeting scar channels to eliminate latest scar potentials without direct ablation. Heart Rhythm. 2024 Dec;21(12):2481-2490. doi: 10.1016/j.hrthm.2024.05.046. Epub 2024 Jun 6.
PubMed 38848856
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ripple Mapping Guided Ablation of Ischaemic Ventricular Tachycardia: A Multi-centre Prospective Clinical Trial.
- ClinicalTrials.gov ID
- NCT03997201
- Acronym / sponsor ID
- RIPPLE-VT / 18SM4892
- Conditions
- Ventricular Tachycardia, Ischemic Heart Disease
- Keywords
- Ventricular, Tachycardia, Ischaemic, Mapping, Ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- 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
- Study start
- 18 Apr 2019 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 25 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective clinical trial
| Arm | Type | Receives |
|---|---|---|
| Ripple Mapping guided ischaemic VT ablation | Other | Procedure: Ripple Mapping guided ischaemic VT ablationPatients referred for ablation of ischaemic VT undergo Ripple Mapping guided procedure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ripple Mapping guided ischaemic VT ablationEndocardial 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. | Procedure or surgery | Ripple Mapping guided ischaemic VT ablation |
Primary outcome
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.
7 secondary outcomes
Achievement of the ablation procedure protocol end-point
Time frame: Procedure
Total ICD therapy rate
Time frame: 12 months
Total VT Episodes
Time frame: 12 months
Appropriate ATP therapy rate
Time frame: 12 months
Appropriate ICD Shocks rate
Time frame: 12 months
Repeat catheter ablation for ischaemic ventricular tachycardia
Time frame: 12 months
All cause mortality
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Derived from this study: PubMed 38848856Katritsis G, Kailey B, Jamil-Copley S, Luther V, Koa-Wing M, Cortez-Dias N, Carpinteiro L, de Sousa J, Martin R, Murray S, Das M, Whinnett Z, Lim PB, Peters NS, Ng FS, Chow AW, Linton NWF, Kanagaratnam P. RIPPLE-VT study: Multicenter prospective evaluation of ventricular tachycardia substrate ablation by targeting scar channels to eliminate latest scar potentials without direct ablation. Heart Rhythm. 2024 Dec;21(12):2481-2490. doi: 10.1016/j.hrthm.2024.05.046. Epub 2024 Jun 6.
- Individual participant dataSharing planned: No
Related trials for Ventricular Tachycardia
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prapa Kanagaratnam principal investigator
Imperial College Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ripple Mapping guided ischaemic VT ablation in people with Ventricular Tachycardia and Ischemic Heart Disease, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined ICD Therapies and Mortality (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03997201, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.