The objective of this clinical study is to evaluate the safety and performance of the Adagio VT Cryoablation System in the ablation treatment of Sustained Monomorphic VT (SMVT)



Eligible Ages
Over 18 Years
Eligible Genders
Accepts Healthy Volunteers

Inclusion Criteria

(IC): - IC 1 Male or female ≥ 18 years - IC 2 Patients with a clinical indication for a catheter ablation due to ischemic and/or non-ischemic heart disease and recurrent symptomatic sustained monomorphic Ventricular Tachycardia - IC 3 Has received an ICD prior to enrollment - IC 4 Patient has had at least 1 documented spontaneous episode of SMVT within the previous 6 months - IC 5 Refractory to, or intolerant of, at least one Class III AAD - IC 6 Subject has LVEF ≥ 20%, confirmed by echo or comparable technique during baseline evaluation or in the previous three months - IC 7 Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study - IC 8 Willingness and ability to give an informed consent

Exclusion Criteria

(EC): - EC 1 Intracardiac thrombus by TTE or TEE within 48 hours prior to the procedure - EC 2 Idiopathic VT - EC 3 Any VT ablation within 4 weeks prior to enrollment - EC 4 More than one prior (>4 weeks) VT ablation or prior surgical treatment for VT within the past 2 years - EC 5 Ventricular tachycardia secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause - EC 6 Cardiogenic shock, unless it is due to incessant monomorphic VT - EC 7 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 index procedure 4. Interatrial baffle, closure device, patch, or PFO occlusion device 5. Coronary artery bypass graft (CABG) procedure within six (6) months prior to the ablation procedure 6. Acute MI or unstable angina in the previous 60 days 7. Mechanical mitral or aortic valve 8. Severe Mitral or Aortic insufficiency or stenosis based on most recent TTE 9. Cardiac myxoma 10. Significant congenital heart disease - EC 8 Acute illness or active systemic infection - EC 9 Any previous history of cryoglobulinemia - EC 10 History of blood clotting or bleeding disease - EC 11 Peripheral vascular disease that precludes LV access - EC 12 Contraindication to heparin - EC 13 Allergy to radiographic contrast dye that cannot be medically managed prior to the ablation procedure - EC 14 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 15 Pregnant, or anticipated pregnancy during study follow-up - EC 16 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 17 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)

Study Design

Study Type
Intervention Model
Single Group Assignment
Primary Purpose
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
VT Cryoablation
all enrolled patients will have a ablation procedure using the Adagio VT Cryoablation System for MVT
  • Device: cryoablation procedure
    ablation procedure for VT using the investigational device

Recruiting Locations

Banner University Medical Center Phoenix
Phoenix, Arizona 85006

More Details

Adagio Medical

Study Contact

Nabil Jubran
949 348 1188

Detailed Description

A prospective, single-arm, multi-center, open label, pre-market, early feasibility clinical study designed to provide safety and efficacy data regarding the use of the Adagio System in the treatment of SMVT. Study subjects will include patients who experience recurrent SMVT and are scheduled for an endocardial VT ablation. Study subjects must have an Implantable Cardioverter Defibrillator (ICD) prior to the cryoablation procedure.


Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.