Follow-up Registry to Monitor the Efficacy and Safety of the Occlutech PLD Device

Occlutech International AB1 site in 1 country144 target enrollmentOctober 2016

ConditionsMitral Paravalvular Leaks (PVL)Aortic Paravalvular Leaks (PVL)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Mitral Paravalvular Leaks (PVL)
Sponsor: Occlutech International AB
Enrollment: 144
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Collect patient data and to monitor the clinical use (safety and efficacy) of the device

Registry

clinicaltrials.gov

Start Date

October 2016

End Date

May 2021

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Occlutech International AB

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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.

Time Frame: 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.

Time Frame: 6 month following implantation