免费获得国外相关药品，最快 1 个工作日回馈药物信息
Ripple Mapping Guided Ablation of Ischaemic Ventricular Tachycardia. (RIPPLE-VT)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ventricular Tachycardia Ischemic Heart Disease | Procedure: Ripple Mapping guided ischaemic VT ablation | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Allocation: | N/A |
| 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 : | June 30, 2021 |
| Estimated Study Completion Date : | June 30, 2022 |
| 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.
|
- Any appropriate ICD therapy [ 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.
- 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
- 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).
- All cause mortality [ Time Frame: 12 months ]All cause mortality
- 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.
- All cause hospitalisation [ Time Frame: 12 months ]All cause hospitalisation
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
| 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 |
| 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 | |
| Principal Investigator: | Prapa Kanagaratnam | Imperial College Healthcare NHS Trust |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 24, 2019 | ||||||||
| First Posted Date ICMJE | June 25, 2019 | ||||||||
| Last Update Posted Date | March 1, 2021 | ||||||||
| Actual Study Start Date ICMJE | April 18, 2019 | ||||||||
| Estimated Primary Completion Date | June 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Any appropriate ICD therapy [ 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.
|
||||||||
| Original Primary Outcome Measures ICMJE |
Any appropriate ICD therapy [ Time Frame: 12 months ] ICD therapy (ATP and shocks) for sustained ventricular tachycardia or ventricular fibrillation.
|
||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE |
|
||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Ripple Mapping Guided Ablation of Ischaemic Ventricular Tachycardia. | ||||||||
| Official Title ICMJE | Ripple Mapping Guided Ablation of Ischaemic Ventricular Tachycardia: A Multi-centre Prospective Clinical Trial. | ||||||||
| 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. | ||||||||
| 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 Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Prospective clinical trial Masking: None (Open Label)Primary Purpose: Treatment |
||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE | 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.
|
||||||||
| Study Arms ICMJE | Ripple Mapping guided ischaemic VT ablation
Patients referred for ablation of ischaemic VT undergo Ripple Mapping guided procedure.
Intervention: Procedure: Ripple Mapping guided ischaemic VT ablation
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
50 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | June 30, 2022 | ||||||||
| Estimated Primary Completion Date | June 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Sex/Gender ICMJE |
|
||||||||
| Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Listed Location Countries ICMJE | United Kingdom | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03997201 | ||||||||
| Other Study ID Numbers ICMJE | 18SM4892 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
|
||||||||
| IPD Sharing Statement ICMJE |
|
||||||||
| Responsible Party | Imperial College Healthcare NHS Trust | ||||||||
| Study Sponsor ICMJE | Imperial College Healthcare NHS Trust | ||||||||
| Collaborators ICMJE |
|
||||||||
| Investigators ICMJE |
|
||||||||
| PRS Account | Imperial College Healthcare NHS Trust | ||||||||
| Verification Date | February 2021 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||
