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

Aortic Paravalvular Leaks (PVL) Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03003481
• Other study ID #: Occ2016_01
• Status: Completed
• Start date: October 2016
• Est. completion date: May 2021

Study information

• Verified date: April 2022
• Source: Occlutech International AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Aortic Paravalvular Leaks (PVL)
• Mitral Paravalvular Leaks (PVL)

Locations

Country	Name	City	State
Italy	Cardiovascular Department	Bergamo

Sponsors (1)

Lead Sponsor	Collaborator
Occlutech International AB

Country where clinical trial is conducted

Italy, 

Outcome

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