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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03003481

Enrollment

144

Registered

2016-12-28

Start date

2016-10-31

Completion date

2021-05-31

Last updated

2022-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Paravalvular Leaks (PVL), Mitral Paravalvular Leaks (PVL)

Brief summary

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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
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

Countries

Italy

Outcome results