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)

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

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

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