Ventricular tachycardia
Conditions
Interventions
A VT ablation procedure is performed by finding the abnormal ventricular heart
tissue that is causing the VT and applying energy with an ablation catheter to
the area. The goal is to apply energy to
Sponsors
Adagio Medical
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: IC 1 Male or female the ages of >= 18 years IC 2 Eligible for a catheter ablation due to Ischemic and/or non-ischemic recurrent symptomatic sustained monomorphic Ventricular Tachycardia also defined as having a similar QRS configuration from beat to beat. IC 3 Has or will be receiving an ICD prior to hospital discharge post procedure. IC 4 Refractory to at least one AAD (Refractory is defined as an AAD not able to treat the arrhythmia satisfactorily or induces unwanted side effects). IC 5 Subject has LVEF > 20%, confirmed by echo or comparable technique in the previous 3 months or during baseline evaluation IC 6 Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study IC 7 Willingness and ability to give an informed consent
Exclusion criteria
Exclusion criteria: EC 1 Any known objective contraindication to ventricular tachycardia ablation, TEE, or anticoagulation, including but not limited to the identification of any cardiac thrombus or evidence of sepsis EC 2 Any duration of continuous arrythmia that is not monomorphic ventricular tachycardia. Multiple monomorphic tachycardia is acceptable, but polymorphic VT is not. EC 3 Any VT ablation within 4 weeks prior to enrollment EC 4 More than one prior (>4 weeks) Ventricular Tachycardia ablation or prior surgical treatment for ventricular tachycardia EC 5 Ventricular tachycardia secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause EC 6 Structural heart disease as described below: a. Class IV heart failure b. Aortic aneurysm c. Previous cardiac surgery or percutaneous coronary intervention within 60 days prior to the procedure d. Interatrial baffle, closure device, patch, or PFO occlusion device e. IVC filter f. Coronary artery bypass graft (CABG) procedure within six (6) months prior to the ablation procedure g. Severe Mitral or Aortic insufficiency or stenosis based on most recent TTE h. Cardiac myxoma i. Significant congenital anomaly j. Recent Myocardial Infarct (MI) or unstable angina, within 60 days prior to the ablation procedure k. Mechanical aortic or mitral valve EC 7 Any previous history of cryoglobulinemia EC 8 History of blood clotting or bleeding disease EC 9 Any prior history of documented cerebral vascular accident (CVA), TIA or systemic embolism (excluding a post-operative Deep Vein Thrombosis, DVT), within 6 months prior to the ablation procedure. EC 10 Breastfeeding, pregnant, or anticipated pregnancy during study follow-up EC 11 Current enrollment in any other study protocol where testing or results from that study may interfere with the procedure or outcome measurements for this study EC 12 Any other condition that, in the judgment of the investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, candidate for heart transplantation, patient with ventricular assist device, or terminal illness with a life expectancy less than 12 months)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Primary Endpoint for Safety is an analysis of the proportion of subjects who are free from definite or probable device/procedure related Major Adverse Events (MAEs) that occur during or within 30 days following the cryoablation procedure. The Primary Endpoint for Clinical Performance is an analysis of the proportion of patients receiving a single cryoablation procedure with freedom from ventricular tachycardia lasting longer than 30 seconds or appropriate ICD intervention until the end of the 6 month follow up period. The Primary Endpoint for Procedure Performance is an analysis of the proportion of subjects with non-inducible clinical monomorphic VT at the conclusion of the initial cryoablation procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety - The proportion of study subjects with probable or definite device or procedure related serious adverse events (SAEs) including MAEs as described above, or serious adverse device effects (SADEs) between 30-days and up to 12 months post-procedure. Events will be adjudicated by an independent Data and Safety Monitoring Board (DSMB) for relatedness to the Adagio System. Performance - The proportion of study subjects with non-inducible sustained monomorphic VT at the end of the ablation procedure - The proportion of study subjects with freedom from Ventricular Tachycardia lasting longer than 30 seconds at 12 months without the use of anti-arrhythmic drugs (AADs) - The proportion of study subjects with freedom from Ventricular Tachycardia lasting longer than 30 seconds at 12 months with previously failed AADs - Reduction of VT burden at 6 and 12 months Descriptive Statistics - Procedure fluoroscopy time - Total ablation time - Total procedure time - Number and location of cryoablation lesions - Number of inducible clinical VTs before and after cryoablation - Number of appropriate and inappropriate ICD therapies (shocks and antitachycardia pacing, ATP) in the follow up period - Mapping and ablation strategies utilized during the ablation procedure - Freedom from cardiovascular (CV) hospitalizations or CV-related ER visits through 12 months - Recording of the use of AADs in the follow up period | — |
Countries
Netherlands
Outcome results
None listed