Follow-up Registry to Monitor the Efficacy and Safety of the Occlutech PLD Device
Completed
- Conditions
- Aortic Paravalvular Leaks (PVL)Mitral Paravalvular Leaks (PVL)
- Registration Number
- NCT03003481
- Lead Sponsor
- Occlutech International AB
- Brief Summary
Collect patient data and to monitor the clinical use (safety and efficacy) of the device
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 144
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Absence of device -and/or procedure-related Serious Adverse Events (SAEs) including deaths, stroke (ischemic stroke that occurs within 24 hours following implantation), systemic embolism or device embolizations. 6 month following implantation Proper closure of the PVL (defined as Reduction in paravalvular regurgitation of ≥ one grade as assessed by echocardiography pre vs post implantation) and/or reduction in the number of hemolysis related transfusions. 6 month following implantation
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie percutaneous transcatheter device efficacy in aortic and mitral paravalvular leak repair?
How does the Occlutech PLD device compare to surgical repair for PVL in terms of clinical outcomes and mortality rates?
Which biomarkers predict optimal response to percutaneous transcatheter PVL closure using the PLD device in heart failure patients?
What are the long-term adverse event profiles of the Occlutech PLD device versus Amplatzer-based PVL interventions?
How do percutaneous transcatheter PVL devices like Occlutech PLD influence left ventricular remodeling and ejection fraction in chronic leak patients?
Trial Locations
- Locations (1)
Cardiovascular Department
🇮🇹Bergamo, Italy
Cardiovascular Department🇮🇹Bergamo, Italy