Closure of Muscular Ventricular Septal Defects With The AMPLATZER™ Muscular VSD Occluder

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-07-31

Study Completion Date

2009-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective is to investigate the safety of the AMPLATZER Muscular VSD Occluder for the treatment of muscular ventricular septal defects, which are hemodynamically significant and are either isolated or in conjunction with other congenital heart defects in infants and children.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Closure of Perimembranous Ventricular Septal Defects With The AMPLATZER® Membranous VSD OCCLUDER

NCT00578708

Membranous Ventricular Septal Defects

COMPLETED PHASE1

Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder - Post Approval Study

NCT00647387

Ventricular Septal Defects

COMPLETED NA

Emergency/Compassionate Use - Muscular VSD Occluder

NCT00590382

Muscular Ventricular Septal +2 more

APPROVED_FOR_MARKETING

Emergency/Compassionate Use - Membranous VSD Occluder

NCT00583505

Membranous Ventricular Septal +2 more

NO_LONGER_AVAILABLE

The AMPLATZER™ Post-infarct Muscular VSD Occluder Humanitarian Device Exemption (H070005) Post Approval Study

NCT03165526

Post-Infarction Ventricular Septal Defect

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The objective of this feasibility study is to investigate the safety of the AMPLATZER Muscular VSD Occluder for the treatment of muscular ventricular septal defects, which are hemodynamically significant and are either isolated or in conjunction with other congenital heart defects in infants and children.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Septal Defects, Ventricular

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Main Cohort

Device closure with the AMPLATZER Muscular VSD Occluder for patients with muscular ventricular septal defects which are hemodynamically significant and are either isolated or present in conjunction with other congenital heart defects.

Group Type EXPERIMENTAL

Device closure with the AMPLATZER Muscular VSD Occluder

Intervention Type DEVICE

Device: AMPLATZER Muscular VSD Occluder

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Device closure with the AMPLATZER Muscular VSD Occluder

Device: AMPLATZER Muscular VSD Occluder

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with hemodynamically significant muscular VSD's (demonstrated by echocardiography or angiography), either isolated or in conjunction with other congenital heart defects
* Age \< 18 years old

Exclusion Criteria

* Less than 4 mm distance from the semilunar (aortic and pulmonary) and atrioventricular valves (mitral and tricuspid)
* Patients with severely increased pulmonary vascular resistance above 7 woods units and a right-to-left shunt and documented irreversible pulmonary vascular disease
* Patients with perimembranous (close to the aortic valve) VSD
* Patients \< 3 kg
* Patients with sepsis (local/generalized)
* Patients with gastritis, gastric ulcer, duodenal ulcer, bleeding disorders etc. and other contraindications to aspirin therapy unless other anti-platelet agents can be administered for 6 months
* Inability to obtain informed consent

Eligible Sex

ALL

Accepts Healthy Volunteers

No