Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® mVSD Cases

NCT05329350 | Recruiting

• 1 other identifier: Occ2016_07
• Study Type: observational
• Target: 50
• Locations: 2 countries
• Sites: 5

Brief Summary

The Occlutech® mVSD is indicated for percutaneous occlusion of hemodynamically or clinically significant muscular ventricular septal defects. The objectives of the study are:

• To confirm the efficacy of Occlutech mVSD in patients requiring transcatheter occlusion (closure) of muscular ventricular septal defects.
• To confirm the safety of Occlutech mVSD in patients requiring transcatheter occlusion (closure) of muscular ventricular septal defects.

Conditions

Muscular Ventricular Septal Defect

Keywords

mVSD Occluder; mVSD; Occlutech; Occlutech mVSD Occluder; Muscular ventricular septal defect closure; Transcatheter closure; Percutaneous occlusion; Periventricular closure; Post-market clinical follow-up; PMCF; Congenital heart defect; Structural heart disease intervention; Echocardiography follow-up

Outcome Measures

Primary Outcomes (2)

• The primary safety endpoint

  The primary safety endpoint is defined as the incidence of Serious Adverse Device Effects (SADEs) including procedure-related death, procedure-related stroke, ischemic stroke, systemic embolism, severe hemolysis, complete heart block requiring pacemaker implantation or device explanation, new onset of severe tricuspid regurgitation (TR), new the onset of severe aortic regurgitation (AR), severe right-left ventricular outflow obstruction (RVOTO-LVOTO), device embolization, cardiac tamponade, infective endocarditis, or vascular complications requiring open heart surgery up to 1 year after the mVSD closure procedure.

  1 year

• The primary efficacy endpoint

  The primary efficacy endpoints will include data obtained 1 year after the mVSD closure procedure for successful implantation of the device with a proper closure of the mVSD (defined as the reduction in muscular ventricular septal shunt to trivial or no shunt at all, as assessed by echocardiography pre- vs post-implantation).

  1 year

Study Arms (1)

muscular ventricular septal defects

patients with muscular ventricular septal defects

Device: Occlutech muscular ventricular septal defect (mVSD) Occluder

Interventions

Occlutech muscular ventricular septal defect (mVSD) Occluder DEVICE

Percutaneous, transcatheter (catheter-based) non-surgical closure of a muscular ventricular septal defect (mVSD) using the Occlutech mVSD Occluder. The device is a self-expandable nitinol wire-mesh occluder with two retention discs connected by a flexible waist and incorporates polyester/PET patches to support defect occlusion and tissue ingrowth. Implantation is performed by experienced operators in a specialized cath lab according to the IFU and local routine; device sizing/selection is guided by imaging (e.g., transthoracic echocardiography, angiography, fluoroscopy). The system is deployed using compatible Occlutech delivery accessories (e.g., Occlutech Pistol Pusher and Occlutech Delivery Set \[ODS v1 or ODS III\], as applicable).

muscular ventricular septal defects

Eligibility Criteria

• Age: 3 Months - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male and female patients of any age with a hemodynamically or clinically significant muscular ventricular septal defect (mVSD) who are candidates for non-surgical closure with the Occlutech mVSD Occluder in routine clinical practice (predominantly pediatric patients). Eligibility is confirmed based on protocol-defined inclusion/exclusion criteria and baseline clinical assessment, including medical history, demographics, vital signs, ECG and echocardiography; laboratory tests may be performed according to local standard of care.

You may qualify if:

• A participant will be eligible for study participation if he/she meets the indication and area of application as laid down in the IFU. The Occlutech mVSD is indicated for percutaneous occlusion of hemodynamically or clinically significant muscular ventricular septal defects.
• Any age
• Male or female.
• Patients understand the nature of the study and provide their informed consent to participation.
• Patients willing and able to attend the follow-up visits and procedures foreseen by study CIP.
• Contraindication
• Hemodynamically relevant VSD shunt
• Congestive heart insufficiency
• Recurrent respiratory infections
• Failure to thrive.
• Significant left ventricle (LV) enlargement
• Significant left atrium (LA) enlargement
• Other clinical indication

You may not qualify if:

• The device is contraindicated for participants known to have any of the following:
• ⦁Active bacterial infections
• Active infection at the time of implantation
• Allergy to antiplatelet or anticoagulant therapy
• Allergy to nickel and/or titanium and/or nickel/titanium-based materials
• Any type of serious infection 1 month before the procedure
• The aortic rim of less than 2 mm
• Demonstrated intracardiac thrombi on echocardiography
• Malignancy where life expectancy is less than 3 years
• mVSD diameter \> 20 mm
• Perimembranous VSD
• Post-MI VSD
• Recent myocardial infarction or a surgical bypass operation in the last 30 days
• Sepsis (local or generalized)
• Septal thickness \> 7 mm in the area of the Occluder placement

Sponsors & Collaborators

• Occlutech International AB: lead

Study Sites (5)

Children's Health Ireland

Dublin, N512, Ireland

NOT YET RECRUITING

İzmir Şehir Hastanesi

Izmir, Bayraklı, 35540, Turkey (Türkiye)

NOT YET RECRUITING

Eskişehir Osmangazi Üniversite Hastanesi

Eskişehir, Odunpazarı, 26040, Turkey (Türkiye)

NOT YET RECRUITING

Dicle Üniversitesi Tıp Fakültesi Hastanesi

Diyarbakır, Sur, Turkey (Türkiye)

NOT YET RECRUITING

Gaziantep Unıversıty Hospital

Gaziantep, Şehitkamil, 27310, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Ahmed Della

CONTACT

+49 151 14139961; ahmed.dellaa@occlutech.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: April 15, 2022
• Study Start: March 3, 2022
• Primary Completion: March 3, 2026
• Study Completion (Estimated): October 1, 2029
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

TU (4); IE (1)