Aortic Paravalvular Leaks (PVL) Clinical Trial
NCT number | NCT03003481 |
Other study ID # | Occ2016_01 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2016 |
Est. completion date | May 2021 |
Verified date | April 2022 |
Source | Occlutech International AB |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Collect patient data and to monitor the clinical use (safety and efficacy) of the device
Status | Completed |
Enrollment | 144 |
Est. completion date | May 2021 |
Est. primary completion date | May 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Cardiovascular Department | Bergamo |
Lead Sponsor | Collaborator |
---|---|
Occlutech International AB |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | ||
Primary | 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 |