Ventricular tachycardia Circulatory System Ventricular tachycardia
Conditions
Interventions
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
Sponsors
Medtronic (United States)
Medtronic Bakken Research Cent
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Czech Republic, England, France, Italy, Spain, United Kingdom
Outcome results
None listed