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OpenTrials
Completed

NCT Number: NCT03003481

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiovascular Department

Bergamo, 24125, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Occlutech International AB

Industry

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Dec 28, 2016
Registry last updated
Apr 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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