Набор скоро начнётся NCT07650032

Cryoablation for Monomorphic Ventricular Tachycardia (VTS)

Без фазы С лечением Ventricular Tachycardia, Sustained Ventricular Tachycardia, Monomorphic

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Ultra Low Temperature Ablation (ULTA).
Кому может быть актуально: Состояния в реестре: Ventricular Tachycardia, Sustained, Ventricular Tachycardia, Monomorphic. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Канада
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Cryoablation for Monomorphic Ventricular Tachycardia IDE Study

Обзор

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)

Подробное описание

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.

Вмешательства

Устройство Ultra Low Temperature Ablation (ULTA)
ablation procedure using the investigational device (vCLAS Ventricular Ablation System including VTS Catheter and Console)

Первичные конечные точки

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. [Срок оценки: 7 days following the ablation procedure]
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 [Срок оценки: 6 months after the procedure]
Primary Procedural Endpoint - Percentage of non-inducibility VT targeted for ablation post-procedure [Срок оценки: at the end of the ablation procedure]

Вторичные конечные точки (2)

Secondary Safety Endpoint - Freedom from definite or probable device or procedure related Serious Adverse Events (SAEs) within 12 months following the ablation procedure [Срок оценки: 12-months post ablation procedure]
Secondary Efficacy Endpoint - Freedom from VT greater than 30 seconds or appropriate ICD intervention at 12 months [Срок оценки: 12-months post ablation procedure]

Критерии участия

Критерии включения

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

Критерии исключения

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:

Idiopathic VT
Automaticity or triggered activity
Bundle Branch Reentry (BBR)
Any focal tachycardia (e.g., papillary, RVOT)
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:

Congenital condition that limits access to the left or right ventricles
Severe aortic or mitral stenosis, severe mitral regurgitation, or severe aortic insufficiency
Active inflammatory processes (e.g., myocarditis) within the past 120 days
Sarcoidosis
Hypertrophic cardiomyopathy
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:

Class IV heart failure
Aortic aneurysm
Previous cardiac surgery or percutaneous coronary intervention within 60 days prior to index procedure
Interatrial baffle, closure device, patch, or PFO occlusion device
Coronary artery bypass graft (CABG) procedure within six (6) months prior to the ablation procedure
Acute MI or unstable angina in the previous 60 days
Mechanical mitral or aortic valve
Cardiac myxoma
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)