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

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-24
• Study First Submitted QC: 2016-12-21
• Study First Posted: 2016-12-28
• Primary Completion: 2021-05
• Study Completion: 2021-05
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-13
• Last Update Posted: 2022-04-20

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

Trial Locations

Locations (1)

Cardiovascular Department; 🇮🇹 Bergamo, Italy