Cryoablation for Monomorphic Ventricular Tachycardia (FULCRUM-VT)

Adagio Medical

Status

Enrolling

Conditions

Sustained VT

Treatments

Device: cryoablation procedure

Study type

Interventional

Funder types

Industry

Identifiers

NCT05675865

CS-300

Details and patient eligibility

About

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

Full description

A prospective, single-arm, multi-center, open label, pre-market, clinical study designed to provide safety and efficacy data regarding the use of the Adagio System in the treatment of scar-mediated SMVT in ischemic and non-ischemic patients.

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.

This IDE study includes two phases, an early feasibility (EFS) phase to support initial device safety and effectiveness, and a Pivotal Study phase to collect safety and effectiveness data for a future PMA marketing application.

Enrollment

206 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (IC):

IC 1 Male or female ≥ 18 years
IC 2 Patients with a clinical indication for catheter ablation due to ischemic and/or non-ischemic heart disease and recurrent symptomatic sustained scar-mediated monomorphic Ventricular Tachycardia.
IC 3 Any of the following:
- Ischemic cardiomyopapthy (ICM) patients with prior history of myocardial infarction with Q waves, focal wall motion abnormality on imaging, fixed perfusion defect correlating with coronary stenosis or prior coronary intervention, 20% ≤ LVEF < 50%.
- non-ischemic cardiomyopathy (NICM) patients with scar in a territory without coronary stenosis as evidenced by CMR imaging within the prior 90 days or intra-procedurally using EAM and PES prior to investigational device use, 20% ≤ LVEF < 50%
- Arrhythmogenic right ventricular cardiomyopathy (ARVC)
IC 4 Has received a market-released ICD prior to enrollment
IC 5 Patient has had at least 1 documented spontaneous episode of SMVT within the previous 6 months
IC 6 Refractory to, or intolerant of, at least one Class III AAD. (Refractory or intolerant defined as AAD failure due to recurrent VT, not tolerated/ desired due to side effects)
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 Presence of isolated epicardial scar(s) requiring epicardial ablation identified by either preoperative CMR imaging within 90 days of procedure or intra-procedurally using EAM and PES prior to investigational device use
EC 3 VTs due to any of the following causes:
1. Idiopathic VT
2. Automaticity or triggered activity
3. Bundle Branch Reentry (BBR)
4. Any focal tachycardia (e.g., papillary, RVOT)
5. Ventricular tachycardia secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause
EC 4 NICM patients only, if any of the following apply:
1. Congenital condition that limits access to the left or right ventricles
2. Severe aortic or mitral stenosis, severe mitral regurgitation, or severe aortic insufficiency
3. Active inflammatory processes (e.g., myocarditis) within the past 120 days
4. Sarcoidosis
5. Hypertrophic cardiomyopathy
6. Drug- or alcohol-induced cardiomyopathy
EC 5 Any VT ablation within 4 weeks prior to enrollment
EC 6 More than one prior (>4 weeks) VT ablation or prior surgical treatment for VT within the past 2 years
EC 7 Cardiogenic shock, unless it is due to incessant monomorphic VT
EC 8 Any other cardiovascular conditions 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. Cardiac myxoma
9. Significant congenital heart disease
EC 9 Acute illness or active systemic infection
EC 10 Any previous history of cryoglobulinemia
EC 11 History of blood clotting or bleeding disease
EC 12 Peripheral vascular disease that precludes LV access
EC 13 Contraindication to heparin
EC 14 Allergy to radiographic contrast dye that cannot be medically managed prior to the ablation procedure
EC 15 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 16 Pregnant, or anticipated pregnancy during study follow-up
EC 17 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 18 Any other condition (e.g., ARVC with extensive free wall scarring) 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)