Active — Not RecruitingNot Applicable

Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study

United States150 participantsStarted 2018-10-30

Plain-language summary

The objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR

Who can participate

Age range60 Years

SexALL

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Inclusion criteria

✓. Severe aortic stenosis, defined as follows:
✓. For symptomatic patients:
✓. For asymptomatic patients:
✓. Patient is considered low risk for SAVR, where low risk is defined as predicted risk of mortality for SAVR \<3% at 30 days per multidisciplinary local heart team assessment.
✓. Bicuspid aortic valve anatomy (all sub-types) confirmed by MDCT.
✓. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

Exclusion criteria

✕. Any condition considered a contraindication for placement of a bioprosthetic valve (eg, subject is indicated for mechanical prosthetic valve).
✕. Age less than 60 years
✕. A known hypersensitivity or contraindication to any of the following that cannot be adequately pre-medicated:
✕. aspirin or heparin (HIT/HITTS) and bivalirudin
✕. ticlopidine and clopidogrel
✕. Nitinol (titanium or nickel)
✕. contrast media
✕. Blood dyscrasias as defined: leukopenia (WBC \<1000 mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states.

What they're measuring

Safety: Percent of Participants With All-Cause Mortality or Disabling Stroke Rate at 30 Days Post-procedure.

Timeframe: 30 days

Efficacy: Percent of Participants Who Meet All Device Success Criteria at 30 Days Post-procedure.

Timeframe: 7 days

Trial details

NCT IDNCT03635424

SponsorMedtronic Cardiovascular

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-11-13

Results submitted2020-10-29

View on ClinicalTrials.gov More Bicuspid Aortic Valve trials