Clinical trials: VSD - Muscular Ventricular Septal Defect
Muscular Ventricular Septal Defect
Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® mVSD Cases
The Occlutech® mVSD is indicated for percutaneous occlusion of hemodynamically or clinically significant muscular ventricular septal defects.
- Trial name
- mVSD Registry (NCT05329350)
- Testing
- Occlutech muscular ventricular septal defect (mVSD) Occluder
- Where
- 6 sites in Ireland, Turkey (Türkiye) and 1 more
- Volunteers
- 50 people
- Sponsor
- Occlutech International AB
Ventricular Septal Defects
Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder - Post Approval Study
The AMPLATZER Muscular VSD Occluder was approved by the US Food and Drug Administration (FDA) in September, 2007. This study is designed to further evaluate the safety and effectiveness in subjects implanted with the AMPLATZER…
- Trial name
- VPA (NCT00647387)
- Testing
- Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder)
- Where
- 51 sites in United States, Canada
- Volunteers
- 92 people
- Sponsor
- Abbott Medical Devices
Heart Septal Defects, Ventricular
Closure of Muscular Ventricular Septal Defects With The AMPLATZER™ Muscular VSD Occluder
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…
- Trial name
- NCT00583791
- Testing
- Device closure with the AMPLATZER Muscular VSD Occluder
- Where
- 11 sites in United States
- Volunteers
- 91 people
- Sponsor
- Abbott Medical Devices
Post-Infarction Heart Rupture, Post-Infarction Ventricular Septal Defect
Mechanical Complications of Acute Myocardial Infarction
Although the incidence of post-AMI mechanical complications has decreased in the last decades, mortality in patients who develop these complications after AMI still remains very high.
- Conditions
- Post-Infarction Heart Rupture, Post-Infarction Ventricular Septal Defect, Post-Infarction Mitral Papillary Muscle Rupture
- Trial name
- CAUTION (NCT03848429)
- Testing
- Surgery for mechanical complications of acute myocardial infarction
- Where
- Netherlands
- Volunteers
- 300 people
- Sponsor
- Maastricht University Medical Center
Ventricular Septal Defect, Papillary Muscle Rupture
Mechanical Complications of Acute Myocardial Infarction: a Multicenter Prospective Study
In 2019, the international study titled "CAUTION Study - 1" (MeChanical complicAtions of acUte myocardial infarcTion: an InternatiOnal multiceNter cohort study), a retrospective multicenter study, was launched and registered on…
- Conditions
- Ventricular Septal Defect, Papillary Muscle Rupture, Cardiac Rupture, Pseudoaneurysm
- Trial name
- CAUTION 2 (NCT06676345)
- Testing
- Surgical treatment, Percutaneous treatment
- Where
- Italy
- Volunteers
- 800 people
- Sponsor
- Maastricht University Medical Center
Post-Infarction Ventricular Septal Defect
The AMPLATZER™ Post-infarct Muscular VSD Occluder Humanitarian Device Exemption (H070005) Post Approval Study
FDA issued a Humanitarian Device Exemption (HDE) approval order for the AMPLATZER™ PIVSD Occluder (H070005) on January 10, 2017.
- Trial name
- PIVSD PAS (NCT03165526)
- Testing
- AMPLATZER™ Post-infarct Muscular VSD Occluder
- Where
- 17 sites in United States
- Volunteers
- 131 people
- Sponsor
- Abbott Medical Devices
Heart Diseases, ASD - Atrial Septal Defect
Abbott Structural Heart Device Registry
The Abbott Structural Heart (SH) Registry is being conducted to confirm the safety and performance of Abbott's SH devices in a post-market, real-world setting.
- Conditions
- Heart Diseases, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect, PFO - Patent Foramen Ovale
- Trial name
- SH-Registry (NCT06590467)
- Testing
- Amplatzer™ Occlusion Devices, Epic™ Surgical Tissue Heart Valve devices
- Where
- 36 sites in United States, Denmark and 8 more
- Volunteers
- 2,500 people
- Sponsor
- Abbott Medical Devices
PFO - Patent Foramen Ovale, ASD - Atrial Septal Defect
Trevisio Post-Approval Study
A single-arm, non-randomized, multi-center clinical study of the Amplatzer™ Trevisio™ Intravascular Delivery System for facilitating percutaneous, transcatheter implantation of the Amplatzer™ Occluder Devices.
- Conditions
- PFO - Patent Foramen Ovale, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect, PIVSD - Post Infarct Muscular Ventricular Septal Defect
- Trial name
- TrevisioPAS (NCT04433520)
- Testing
- Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer PFO Occluder, ASO or Amplatzer Cribriform Occluder, Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder
- Where
- 22 sites in France, Germany and 5 more
- Volunteers
- 254 people
- Sponsor
- Abbott Medical Devices