Ventricular Tachycardia, Monomorphic, Ventricular Tachycardia, Sustained
Conditions
Keywords
cryoablation, monomorphic VT, sustained monomorphic VT, Ultra Low Temperature Ablation, ULTA
Brief 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)
Detailed 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. The VTS study is being initiated to collect safety and effectiveness data and support future PMA supplement marketing application.
Interventions
DEVICEUltra Low Temperature Ablation (ULTA)
ablation procedure using the investigational device (vCLAS Ventricular Ablation System including VTS Catheter and Console)
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 ≥ 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Safety Endpoint - Freedom from definite or probable device or procedure related Serious Adverse Events (SAEs) within 12 months following the ablation procedure | 12-months post ablation procedure | Secondary Safety Endpoint is defined as freedom from definite or probable device or procedure related Serious Adverse Events (SAEs) within 12 months following the ablation procedure. Events will be adjudicated by an independent Clinical Events Committee (CEC). |
| Secondary Efficacy Endpoint - Freedom from VT greater than 30 seconds or appropriate ICD intervention at 12 months | 12-months post ablation procedure | Secondary Efficacy Endpoint is defined as freedom from Ventricular Tachycardia lasting longer than 30 seconds or appropriate ICD intervention at 12 months |
Countries
Canada, United States
Contacts
CONTACTNabil Jubran, MS
CONTACTDoug Kurschinski
Outcome results
None listed