An International Multicenter Study on Transcatheter Device Closure of Perimembranous Ventricular Septal Defects

Обзор

The international multicenter registry aims to gather real-world data on patient outcomes and assess the procedural success and performance of various device occluders used in the transcatheter treatment of pediatric and adult patients with perimembranous ventricular septal defects (PmVSD).

Подробное описание

This is a non-randomized, multicenter, international, non-interventional, observational, retrospective post-marketing clinical follow-up study designed to evaluate the feasibility, safety, and efficacy of transcatheter closure of perimembranous ventricular septal defects (PmVSD) using commercially available device occluders, whether specifically designed for this purpose or used off-label.

Вмешательства

• Устройство Transcatheter device closure of perimembranous ventricular septal defects (PmVSDs)
  Transcatheter closure of perimembranous ventricular septal defects (PmVSDs) using an occluder device either specifically designed for this purpose or used off-label.

Первичные конечные точки

• Twelve-month composite non-hierarchical clinical success [Срок оценки: From implant attempt to 12 hours post-procedure]
• Technical success [Срок оценки: From implant attempt to 12 hours post-procedure]
• Closure success [Срок оценки: From implant attempt to 12 hours post-procedure]
• Procedural success [Срок оценки: From implant attempt to 12 hours post-procedure]
• Clinical success [Срок оценки: From implant attempt to 12-month post-procedure]
• Freedom from procedure or device-related major adverse events [Срок оценки: From implant attempt to 12-month post-procedure]

Вторичные конечные точки (4)

• Short-term complications (≤30 days) [Срок оценки: From implant attempt to 30 days post-procedure]
• Long-term outcomes [Срок оценки: From implant attempt to 60-month post-procedure]
• Rate of incomplete closure at the 24-month follow-up. [Срок оценки: From implant attempt to 24-month post-procedure]
• Functional and quality-of-life measures [Срок оценки: From implant attempt to 48-month post-procedure]

Критерии участия

Критерии включения

• Patients with perimembranous ventricular septal defects (PmVSD), as defined by 2D transthoracic echocardiography according to previously published classifications.
• Defect size between 3 mm and <20 mm on the left ventricular side, as measured by 2D echocardiography.
• Left-to-right ventricular shunt.
• Age ≥3 months and body weight≥5 kg.
• Symptomatic patients (heart failure, failure to thrive, recurrent respiratory infections, and rest or exercise dyspnea) or asymptomatic patients with progressive heart enlargement.
• History of infective endocarditis related to the PmVSD or hemodynamically significant PmVSD with: Qp/Qs >1.5 on catheterization, left ventricular volume overload (LVEDD z-score >2) based on echocardiography, or pulmonary hypertension on catheterization (mean pulmonary artery pressure >20 mmHg).
• Presence or absence of aortic valve prolapse, with or without regurgitation.
• Presence or absence of a membranous septal aneurysm, with or without inlet or outlet extension.

Критерии исключения

• Eisenmenger physiology (pulmonary vascular resistance > 8 Wood units, nonreactive) with an exclusive right-to-left shunt.
• Pre-existing complete heart block or high-risk proximity of the conduction system to the defect without prior pacemaker implantation.
• Severe aortic or tricuspid valve disease requiring surgical or catheter-based intervention.
• Pregnancy or planned pregnancy if the procedure involves X-ray exposure.
• Extensive congenital cardiac anomalies requiring surgery.
• Thrombus at the implant site or documented venous thrombus in access vessels.
• Sepsis, active endocarditis, or bacterial infections within one month pre-procedure.
• Uncontrolled bleeding or clotting disorders.
• Contraindications to antiplatelet therapy or refusal of blood transfusions.
• Cardiac malformations dependent on the presence of a perimembranous ventricular septal defect (PmVSD).
• Lack of informed written consent for the procedure
• Failure to attend any follow-up visit post-discharge.
• Patients under guardianship or curatorship
• Patients deprived of liberty
• Patients under court protection
• Patients or legal guardians refusing the use of personal data for this research

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 4 центра

• University Hospital of Bordeaux — Bordeaux
• Marie Lannelongue Hospital — Le Plessis-Robinson
• Lille University Hospital — Lille
• Toulouse University Hospital — Toulouse

Turkey (Türkiye) · 4 центра

• Ankara City Hospital — Ankara
• Koç University — Istanbul
• Umraniye Training and Education Hospital — Istanbul
• SBU Tepecik Training and Research Hospital — Izmir

Дания · 1 центр

• Copenhagen University Hospital, Rigshospitalet — Copenhagen

Германия · 1 центр

• University Children's Hospital — Tübingen

Индонезия · 1 центр

• National Cardiovascular Center of Harapan Kita — Jakarta

Иран · 1 центр

• Rajaie Cardiovascular, Medical and Research Center — Tehran

Ливан · 1 центр

• Hôtel-Dieu de France University Medical Center — Beirut

Мексика · 1 центр

• Hospital de Especialidades Pediátricas — Chiapas

Пакистан · 1 центр

• The Children's Hospital — Lahore

Польша · 1 центр

• Silesian Center for Heart Diseases — Zabrze

Саудовская Аравия · 1 центр

• Madinah Cardiac Center MCC — Madinah

ОАЭ · 1 центр

• Al Jalila Children's Speciality Hospital — Dubai

Идентификаторы

NCT: NCT06823635 · PERI-CLOSE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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