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

Occlutech

Status: Completed

Conditions: Mitral Paravalvular Leaks (PVL); Aortic Paravalvular Leaks (PVL)

Study type: Observational

Funder types: Industry

Identifiers

NCT03003481

Occ2016_01

Details and patient eligibility

About

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

Enrollment: 144 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

• Patients with PVL associated hemolysis, recurrent blood transfusions, or hemodynamically significant heart failure

Exclusion criteria

The device is contraindicated for patients known to have any of the following:

• Known coagulation dysfunction
• Leak reversal with separate or significant residual or recurrent leak
• Acute infection
• Known intra-cardiac thrombi
• Recent pelvic venous thrombosis
• Recent myocardial infarction or a surgical bypass operation in the last 30 days
• If adequate oral anticoagulation therapy / antiplatelet aggregation inhibition is not possible post-procedurally
• Intolerance of contrast agent