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

April 13, 2022 updated by: Occlutech International AB
Collect patient data and to monitor the clinical use (safety and efficacy) of the device

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

144

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bergamo, Italy, 24125
        • Cardiovascular Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with aortic or mitral PVL

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: 6 month following implantation
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.
Time Frame: 6 month following implantation
6 month following implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Occlutech International AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (ACTUAL)

May 1, 2021

Study Completion (ACTUAL)

May 1, 2021

Study Registration Dates

First Submitted

October 24, 2016

First Submitted That Met QC Criteria

December 21, 2016

First Posted (ESTIMATE)

December 28, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 20, 2022

Last Update Submitted That Met QC Criteria

April 13, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Occ2016_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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