Status:
ACTIVE_NOT_RECRUITING
Cryoablation for Monomorphic Ventricular Tachycardia (CryoCure-VT)
Lead Sponsor:
Adagio Medical
Conditions:
Monomorphic Ventricular Tachycardia
Eligibility:
All Genders
18+ years
Phase:
NA
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 v...
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 Defibrillato...
Eligibility Criteria
Inclusion
- 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
- 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:
- Class IV heart failure
- Aortic aneurysm
- Previous cardiac surgery or percutaneous coronary intervention within 60 days prior to the procedure
- Interatrial baffle, closure device, patch, or PFO occlusion device
- IVC filter
- Coronary artery bypass graft (CABG) procedure within six (6) months prior to the ablation procedure
- Severe Mitral or Aortic insufficiency or stenosis based on most recent TTE
- Cardiac myxoma
- Significant congenital anomaly
- Recent Myocardial Infarct (MI) or unstable angina, within 60 days prior to the ablation procedure
- 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)
Key Trial Info
Start Date :
May 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04893317
Start Date
May 26 2021
End Date
September 30 2024
Last Update
January 30 2024
Active Locations (7)
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1
Onze Lieve Vrouwziekenhuis
Aalst, Belgium, 9300
2
McGill University Health Centre
Montreal, Canada
3
Montreal Hear Institute
Montreal, Canada
4
Nemocnice na Homolce
Prague, Czechia