Ultra Low Temperature Ablation (ULTA): ablation procedure using the investigational device (vCLAS Ventricular Ablation System including VTS Catheter and Console)
Study summary
The objective of this clinical study is to evaluate the safety and effectiveness of the Adagio Medical vCLAS Ventricular Ablation System (including VTS Catheter and Console) in the ablation treatment of Sustained Monomorphic Ventricular Tachycardia (SMVT)
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 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)
Primary outcome measure(s)
Primary Safety Endpoint - Freedom from definite or probable device or procedure related Major Adverse Events (MAEs) that occur within 7 days following the ablation procedure. — 7 days following the ablation procedure Primary Safety Endpoint is freedom from definite or probable device or procedure related Major Adverse Events (MAEs) that occur within 7 days following the ablation procedure.
Events will be adjudicated by an independent Clinical Events Committee (CEC). MAEs include any of the following: • Death • Acute myocardial infarction • Cardiac perforation/pericardial tamponade • Cerebral infarct or systemic embolism • Major bleeding requiring transfusion • Acute Mitral, Tricuspid or Aortic valve damage resulting in moderate or severe regurgitation • Access site complications requiring medical or surgical intervention • Pericarditis • Heart block requiring a permanent pacemaker • Other serious adverse device effects (SADEs), including TIAs, adjudicated by an independent Clinical Events Committee (CEC) to be probably or definitely related to the Adagio System.
Primary Efficacy Endpoint - Freedom from recurrent sustained MMVT in the absence of a new AAD or increase in dose of a pre-ablation AAD for VT management at 6 months following the ablation procedure — 6 months after the procedure Primary Efficacy Endpoint is defined as freedom from recurrent sustained MMVT in the absence of a new AAD or increase in dose of a pre-ablation AAD for VT management at 6 months following the ablation procedure, where sustained MMVT is defined as continuous MMVT for \> 30 seconds (programmed monitoring zone only), or MMVT requiring appropriate ICD intervention regardless of duration. All ICD interrogation reports will be adjudicated by an independent VT Event Committee (VTEC) to support the primary efficacy endpoint.
Primary Procedural Endpoint - Percentage of non-inducibility VT targeted for ablation post-procedure — at the end of the ablation procedure Primary Procedural Endpoint is defined as non-inducibility of any VT targeted for ablation at the end of the procedure
Trial sites (10)
Facility
City
Region
Status
Banner University Medical Center Phoenix
Phoenix
Arizona
Recruiting
MemorialCare Long Beach Medical Center
Long Beach
California
Recruiting
Brigham and Women's Hospital
Boston
Massachusetts
Recruiting
Northwell Health- Staten Island University Hospital
Staten Island
New York
Recruiting
Hospital of University of Pennsylvania
Philadelphia
Pennsylvania
Recruiting
Medical Center of South Carolina (MUSC)
Charleston
South Carolina
Recruiting
Vanderbilt University Medical Center
Nashville
Tennessee
Recruiting
Virginia Commonwealth University
Richmond
Virginia
Recruiting
McGill University Health Centre (MUHC), Montreal General Hospital (MGH)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.