Clinical evaluation of the DiamondTemp™ Ablation System for the treatment of ventricular tachycardia (a heart rhythm disorder caused by abnormal electrical signals in the ventricle of the heart)
| ISRCTN | ISRCTN84509594 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84509594 |
| IRAS number | 308088 |
| Secondary identifying numbers | TP00923 - MDT20020, IRAS 308088, CPMS 51072 |
- Submission date
- 21/01/2022
- Registration date
- 22/04/2024
- Last edited
- 19/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Ventricular tachycardia is a type of arrhythmia that causes the heart to beat very fast. Ventricular tachycardia occurs in patients with weakened heart muscle or when scarring develops in the heart due to a myocardial infarction (heart attack). The scar or fibrosis can interfere with the normal electrical impulses of the heart, leading to a short-circuiting of the rhythm. A ventricular tachycardia can be treated with catheter ablation, a procedure that uses energy to make small scars in the heart tissue to prevent abnormal electrical signals from moving through the heart. The aim of this study is to evaluate the clinical results, safety and performance of the DiamondTemp™ Ablation System for the treatment of ventricular tachycardia.
Who can participate?
Patients aged over 18 years with ventricular tachycardia who are suitable candidates for catheter ablation and did not respond to anti-arrhythmic drug treatment
What does the study involve?
The ablation procedure will be performed according to routine hospital practice. The follow-up period is intended to align with standard practice and participants will be followed for 12 months after the procedure to collect safety and effectiveness data.
What are the possible benefits and risks of participating?
The Ablation System in this study is approved for use in Europe and the risks from taking part in this study are the same as someone undergoing routine ablation treatment under mapping /navigation guidance. It is not known whether participants will benefit from the treatment with this new ablation catheter system. Investigations such as this are performed in order to establish the relative risks and advantages of these treatments.
Where is the study run from?
Medtronic, Bakken Research Center B.V. (Netherlands)
When is the study starting and how long is it expected to run for?
March 2018 to January 2024
Who is funding the study?
Medtronic (USA)
Who is the main contact?
Sandra Jacobs
sandra.jacobs@medtronic.com
Contact information
Scientific
Medtronic, Bakken Research Center B.V.
Endepolsdomein 5
Maastricht
6229 GW
Netherlands
| Phone | +31 (0)43 35 66 566 |
|---|---|
| sandra.jacobs@medtronic.com |
Principal Investigator
Electrophysiology Institut klinické a experimentální medicíny (IKEM), Vídeňská 1958/9
Prague 4
140 21
Czech Republic
| Phone | None provided |
|---|---|
| josef.kautzner@ikem.cz |
Study information
| Study design | Prospective multi-center observational single-arm study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Single-arm study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A clinical evaluation of the DiamondTemp™ System TempeRAture Controlled Ablation for the treatment of Ventricular Tachycardia |
| Study acronym | TRAC VT |
| Study hypothesis | The objective of this study is to assess the safety and performance of the DiamondTemp ™ Ablation System for the treatment of ventricular tachycardia (VT). The study is observational in nature and there is no pre-specified study hypothesis. |
| Ethics approval(s) |
1. Approved 26/07/2018, Ethics Committee for Research with Medicinal Products (CEIm, Hospital Universitario Ramón y Cajal, Madrid, None provided, Spain; +34 91 336 83 22; ceic.hrc@salud.madrid.org), ref: None provided 2. Approved 25/02/2022, West Midlands -South Birmingham Research Ethics Committee (Nottingham Health Research Authority, 2nd Floor, Equinox House, City link, Nottingham, NG2 4LA, United Kingdom; +44 (0)207 104 8000; southbirmingham.rec@hra.nhs.uk), ref: 22/WM/0017 3. Approved 23/05/2018, Ethics Committee of the Institute for Clinical and Experimental Medicine and Thomayer Hospital (IKEM, Videnska 800, Praha, 14059, Czech Republic; +420 (0)236 055 012; eticka.komise@ftn.cz), ref: 24486/20 (A-18-03) 4. Approved 04/10/2018, Comité De Protection Des Personnes (CPP Ouest II, CHU Angers, None provided, France; +33 (0)2 41 35 52 15; cpp.ouest2@univ.angers.fr), ref: 2018/63 2018-A02425-50 5. Approved 03/10/2018, Ethics Committee of the IRCCS Istituto Europeo di Oncologia e Centro Cardiologico Monzino (European Oncology Institute and Monzino Cardiology Center Research Hospital) (None provided, Milan, None provided, Italy; +39 (0)2 57 489 848; comitato.etico@ieo.it), ref: R857/18-CCM 902 |
| Condition | Ventricular tachycardia |
| Intervention | The DiamondTemp Ablation Catheter used with the DiamondTemp RF Generator/Pump system is indicated for use in patients requiring cardiac electrophysiological mapping (stimulation and recording) and for cardiac ablation with monitoring of tissue temperature during ablation. The DiamondTemp Ablation Catheter is a commercially available catheter that, when used with the DiamondTemp RF Generator and Irrigation Pump, is similar in functionality to existing open-irrigated electrophysiology (EP) ablation catheters and RF Generator/Pump Systems currently on the market. Radiofrequency (RF) ablation will be performed using the DiamondTemp Ablation System. The ablation procedure will be performed according to routine hospital practice. The follow up period is intended to align with standard practice and subjects will be followed for 12 months post-procedure. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Phase III/IV |
| Drug / device / biological / vaccine name(s) | DiamondTemp Ablation System |
| Primary outcome measure | The acute outcome is the successful ventricular tachycardia (VT) ablation (spontaneous and induced VT episodes), defined as the non-inducibility of VT, and the acute success rate determined as the percentage of acute successes out of all attempted DiamondTemp ablation procedures and index procedures, accompanied by a 95% exact Binomial confidence interval, measured using programmed electrical stimulation at the end of the ablation procedure. The primary safety endpoint is considered successful if the subject is free from the composite of the following cardiovascular-specific SAEs within 30 days post-ablation that are adjudicated by the Clinical Events Committee (CEC) as (possibly) related to the DiamondTemp ablation procedure or system measured using patient medical records: 1. Cardiovascular-related death post-ablation 2. Cardiac tamponade/perforation 3. Bleeding complication 4. Myocardial infarction 5. Stroke or transient ischemic attack (TIA) 6. Thromboembolism 7. Pulmonary edema The primary safety freedom rate will be estimated as the percentage of subjects free from the composite SAEs within 30 days post-ablation out of all subjects who attempt the DiamondTemp ablation procedure, along with a 95% exact Binomial confidence interval |
| Secondary outcome measures | The following secondary outcome measures are assessed using data recorded in the patient’s medical records (scheduled study follow-up visits, unscheduled study follow-up visits, reported Adverse Events and ICD/CRT device information: a review of events from the device): 1. Chronic success is defined as no recurrence of VT through 6 months post-ablation procedure 2. Chronic safety is defined as freedom from cardiovascular-specific SAEs through 6-month post-ablation procedures that are adjudicated by the CEC as (possibly) related to the DiamondTemp ablation procedure or system. The list of cardiovascular-specific SAEs is equal to the list used for the primary safety objective. 3. Long-term safety is defined as freedom from cardiovascular-specific deaths through the 12-month post-ablation procedure that is adjudicated by the CEC as (possibly) related to the DiamondTemp ablation procedure or system |
| Overall study start date | 13/03/2018 |
| Overall study end date | 01/01/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 38 |
| Participant inclusion criteria | 1. Above 18 years of age or minimum age as required by local law 2. Suitable candidate for catheter ablation 3. Subjects with symptomatic frequent monomorphic ventricular ectopy OR at least one documented episode of sustained VT meeting all the criteria below: 3.1. Episode occurring within previous 6 months 3.2. Episode must be monomorphic 3.3. Episode requiring external cardioversion or ICD anti-tachycardia pacing (ATP) or shocks 3.4. Structural heart disease with ischemic or non-ischemic dilated cardiomyopathy 4. Subject failed any anti-arrhythmic drug (AAD) regime unless contraindicated or not tolerated 5. Subject is willing and able to provide written consent |
| Participant exclusion criteria | 1. Contraindication to catheter ablation 2. Ventricular tachycardia due to transient, reversible causes 3. Exclusively polymorphic VT 4. Electrolyte imbalance 5. Use of left ventricular assist device (LVAD) or circulatory assist devices 6. Stroke (<6 months) 7. Presence of a left atrial or ventricular thrombus 8. Severe cerebrovascular disease 9. Active gastrointestinal bleeding 10. Unstable angina 11. Renal failure (on dialysis or at risk of requiring dialysis) 12. Active infection or fever 13. Currently NYHA Functional Class IV heart failure 14. Left Ventricular Ejection Fraction (LVEF) <20% 15. Myocardial infarct or previous cardiac surgery (<3 months) 16. Prosthetic mitral or aortic valve 17. Mitral or aortic valvular disease requiring immediate surgical intervention 18. Active ischemia who are eligible for revascularization 19. Contraindication to heparin 20. Thrombocytopenia or coagulopathy 21. Uncontrolled diabetes needing therapy 22. Pregnancy or women of child-bearing potential 23. Unable to give informed consent 24. Unable to attend follow-up visits 25. Life expectancy <12 months based on medical history or the medical judgement of the investigator. 26. Enrollment in a concurrent clinical study that in the judgement of the investigator would impact study outcomes 27. Acute or chronic medical condition that in the judgment of the investigator would increase risk to the patient or deem the patient inappropriate to participate in the study |
| Recruitment start date | 04/06/2018 |
| Recruitment end date | 31/08/2022 |
Locations
Countries of recruitment
- Czech Republic
- England
- France
- Italy
- Spain
- United Kingdom
Study participating centres
140 21 Prague 4
Prague
140 21
Czech Republic
Via C. Parea 4
Milan
20138
Italy
Madrid
28034
Spain
Toulouse
31076
France
Coventry
CV2 2DX
United Kingdom
Rouen
76031
France
Sponsor information
Industry
Cardiac Ablation Solutions
8200 Coral Sea Street NE
Mounds View
Minneapolis
55112
United States of America
| Phone | +1 (0)800 328 2518 |
|---|---|
| rs.cusvasorders@medtronic.com | |
| Website | http://www.medtronic.com/us-en/index.html |
"ROR" |
https://ror.org/00grd1h17 |
Industry
Endepolsdomein 5
Maastricht
6229 GW
Netherlands
| Phone | +31 (0)43 35 66 566 |
|---|---|
| bakkenresearchcenter@medtronic.com | |
| Website | https://www.medtronic.com/nl-nl/about/medtronic-netherlands/bakken-research-center.html |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Medtronic Inc.
- Location
- United States of America
Results and Publications
| Intention to publish date | 01/01/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available because these data may be used for future product and therapy development. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/02/2025 | 19/02/2025 | Yes | No |
Editorial Notes
19/02/2025: Publication reference and total final enrolment added.
02/05/2024: Internal review.
22/04/2024: Study's existence confirmed by the Ethics Committee for Research with Medicinal Products CEIm, Hospital Universitario Ramón y Cajal.
