Monomorphic Ventricular Tachycardia
Conditions
Brief summary
A prospective, single-arm, multi-center, pre-market, clinical study designed to provide safety and performance data regarding the use of the Adagio Medical VT Cryoablation System in the treatment of ventricular tachycardia.
Detailed description
Study subjects will include patients who experience recurrent monomorphic VT and are scheduled for an endocardial VT ablation. Study subjects have or will have an Implantable Cardioverter Defibrillator (ICD) prior to hospital discharge following the cryoablation procedure. 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 create a scar or destroy the tissue that causes the VT, such that VT is no longer present or inducible.
Interventions
DEVICEAblation in the ventricles with the Adagio Medical VT Cryoablation System
The Adagio Medical VT Cryoablation System is indicated for the treatment of monomorphic ventricular tachycardia by ablation of arrhythmogenic tissue that drives and maintains these arrhythmias
Sponsors
Adagio Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
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: 1. Class IV heart failure 2. Aortic aneurysm 3. Previous cardiac surgery or percutaneous coronary intervention within 60 days prior to the procedure 4. Interatrial baffle, closure device, patch, or PFO occlusion device 5. IVC filter 6. Coronary artery bypass graft (CABG) procedure within six (6) months prior to the ablation procedure 7. Severe Mitral or Aortic insufficiency or stenosis based on most recent TTE 8. Cardiac myxoma 9. Significant congenital anomaly 10. Recent Myocardial Infarct (MI) or unstable angina, within 60 days prior to the ablation procedure 11. 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 | Description |
|---|---|---|
| Primary Endpoint for Safety | during and 30 days post cryoablation procedure | 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 |
| Primary Endpoint for Clinical Performance | 6 month post cryoablation procedure | 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. |
| Primary Endpoint for Procedure Performance | at the end of the cryoablation procedure | 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 | Description |
|---|---|---|
| Safety - freedom from procedure or device related SAE | 12 months post cryoablation procedure | 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 up to 12 months post-procedure. |
| Performance - non-inducible sustained monomorphic VT | at the end of the cryoablation procedure | The proportion of study subjects with non-inducible sustained monomorphic VT at the end of the ablation procedure |
| Performance - freedom from VT at 12-M off AADs | 12 months post cryoablation 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) |
| Performance - freedom from VT at 12-M on previously failed AADs | 12 months post cryoablation procedure | The proportion of study subjects with freedom from Ventricular Tachycardia lasting longer than 30 seconds at 12 months with previously failed anti-arrhythmic drugs (AADs) |
| Performance - VT burden | 6 and 12 months post cryoablation procedure | Reduction of VT burden at 6 and 12 months |
| Descriptive Statistical Outcome - fluoroscopy time | at the end of the cryoablation procedure | Procedure fluoroscopy time |
| Descriptive Statistical Outcome - ablation time | at the end of the cryoablation procedure | Total ablation time |
| Descriptive Statistical Outcome - procedure time | at the end of the cryoablation procedure | Total ablation time |
| Descriptive Statistical Outcome - cryoablation lesions | at the end of the cryoablation procedure | Number and location of cryoablation lesions |
| Descriptive Statistical Outcome - inducible VTs | at the end of the cryoablation procedure | Number of inducible clinical VTs before and after cryoablation |
| Descriptive Statistical Outcome - ICD shocks | 12 months post cryoablation procedure | Number of appropriate and inappropriate ICD therapies (shocks and pacing) in the follow up period |
| Descriptive Statistical Outcome - ablation strategies | at the end of the cryoablation procedure | Mapping and ablation strategies utilized during the ablation procedure |
| Descriptive Statistical Outcome - Hospitalization | 12 months post cryoablation procedure | Freedom from cardiovascular (CV) hospitalizations or CV-related ER visits through 12 months |
| Descriptive Statistical Outcome - AADs use | 12 months post cryoablation procedure | Recording of the use of AADs in the follow up period |
Countries
Belgium, Canada, Czechia, France, Germany, Netherlands
Outcome results
None listed