Cryoablation for Monomorphic Ventricular Tachycardia
ConditionSustained VT
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAdagio Medical
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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%
Disqualifiers
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
Idiopathic VT
Automaticity or triggered activity
Trial design
Design model
Single group
Treatments tested in this trial
cryoablation procedure
Deviceablation procedure for VT using the investigational device
Treatment groups
206 Participants
are divided into 1 treatment groupGroup A: VT CryoablationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary Safety Endpoint for EFS and Pivotal phases is freedom from definite or probable device or procedure related Major Adverse Events (MAEs) that occur within 7 days following the cryoablation 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.
Time frame
7 days following the ablation procedure2
Primary Procedural Endpoint for EFS and Pivotal - Analysis of the proportion of subjects with non-inducible VT or no further ablation targets meeting the criteria for ablation at the end of the cryoablation procedure.
Documentation of non-inducibility of any VT targeted for ablation at the end of procedure.
Time frame
During Procedure3
Primary Efficacy Endpoint for Pivotal Phase
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.
Time frame
6 months after the procedureSecondary outcomes
1
Secondary Safety Endpoint - Analysis of the proportion of subjects with freedom from definite or probable device or procedure related MAEs that occur within 30 days (EFS) or SAEs within 12 months (pivotal) following the cryoablation procedure.
Events will be adjudicated by an independent Clinical Events Committee (CEC).
Time frame
1 month post cryoablation procedure2
Secondary Efficacy Endpoint for EFS and Pivotal - Analysis of the proportion of subjects with freedom from inducible MMVT <30s
Freedom from inducible MMVT with a cycle length similar to (within 30 ms) or slower than the targeted VT and lasting longer than 30 seconds at the end of the ablation procedure.
Time frame
6-month post cryoablation procedure3
Secondary Efficacy Endpoint for EFS and Pivotal - Analysis of the proportion of subjects with freedom from VT > 30 seconds
Freedom from Ventricular Tachycardia lasting longer than 30 seconds or appropriate ICD intervention at 6 months (EFS) or 12 months (pivotal).
Time frame
6-month post cryoablation procedure4
Secondary Efficacy Endpoint for EFS and Pivotal - Analysis of the proportion of subjects with freedom from VT > 30 seconds without AAD
Freedom from Ventricular Tachycardia lasting longer than 30 seconds or appropriate ICD intervention at 6 months in the absence of new AADs or increase in dose of pre-ablation AADs. Drug changes related specifically to management of atrial arrhythmias will not be included in the analysis of this endpoint (EFS
Time frame
6-month post cryoablation procedureSponsors and contacts
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Source ClinicalTrials.gov