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Behavior of Valve Leaflets Following Aortic Valve Implant

NCT03200574 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2024-03-06

Study results available
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Summary

This is a prospective, interventional, multi-center trial to report the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a commercially approved LivaNova bioprosthetic aortic heart valve up to 1 year post implant.

Conditions

  • Aortic-valve Replacement

Interventions

DIAGNOSTIC_TEST

4D Cardiac CT Scan

4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy

DEVICE

LivaNova Bioprothetic Aortic Valve Implant

Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.

Sponsors & Collaborators

  • LivaNova

    collaborator INDUSTRY

  • Corcym S.r.l

    lead INDUSTRY

Principal Investigators

  • Niv Ad, MD · Washington Adventist Hospital

  • Federico Asch, MD · Medstar Health Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-06
Primary Completion
2020-06-15
Completion
2021-02-25
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03200574 on ClinicalTrials.gov