Transcatheter Aortic Valve Replacement (TAVR) With Medtronic TAVR System in Patients With Severe Bicuspid Aortic Valve Stenosis and at Low Predicted Risk of Mortality With Surgical Aortic Valve Replacement (SAVR)

Medtronic Cardiovascular25 sites in 1 country150 target enrollmentOctober 30, 2018

ConditionsBicuspid Aortic Valve

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Bicuspid Aortic Valve
Sponsor: Medtronic Cardiovascular
Enrollment: 150
Locations: 25
Primary Endpoint: Safety: Percent of Participants With All-Cause Mortality or Disabling Stroke Rate at 30 Days Post-procedure.
Status: Active, not recruiting
Last Updated: 6 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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

Detailed Description

Multi-center, prospective, single arm All subjects will be treated with a Medtronic TAVR system. Subject follow-ups will be conducted at pre and post-procedure, discharge, 30 days, 1 year, and annually through 10 years

Registry

clinicaltrials.gov

Start Date

October 30, 2018

End Date

December 1, 2030

Last Updated

6 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Medtronic Cardiovascular

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Severe aortic stenosis, defined as follows:
•For symptomatic patients:
•Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), OR mean gradient ≥40 mmHg, OR Maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest
•For asymptomatic patients:
•Very severe aortic stenosis with an aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND maximal aortic velocity ≥5.0 m/sec, or mean gradient ≥60 mmHg by transthoracic echocardiography at rest, OR
•Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND a mean gradient ≥40 mmHg or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND an exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR
•Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND mean gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND a left ventricular ejection fraction \<50%.
•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.
•Ongoing sepsis, including active endocarditis.
•Any percutaneous coronary or peripheral interventional procedure with a bare metal stent or drug eluting stent performed within 30 days prior to screening committee approval.

Outcomes

Primary Outcomes

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

Time Frame: 30 days

Rate of of all-cause mortality or disabling stroke rate at 30 days

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

Time Frame: 7 days

Device success rate, defined as: * Absence of procedural mortality, AND * Correct positioning of a single prosthetic heart valve into the proper anatomical location, AND * Absence of moderate or severe total prosthetic valve regurgitation (at 18 hours to 7 days)

Secondary Outcomes

All Stroke (Disabling and Non-Disabling) Rate(1 year and annually through 10 years)
Percent of Participants With a Life-Threatening Bleeding Event at 30 Days Post-procedure.(30 days)
Percent of Participant With Prosthetic Valve Thrombosis at 30 Days Post-procedure.(30 days)
Hemodynamic Performance Metrics by Doppler Echocardiography: Mean Aortic Gradient Reported as Mean Average at Baseline and 30 Days(30 days)
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at Baseline and 30 Days(30 days)
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Transvalvular Prosthetic Regurgitation at 30 Days(30 days)
All-Cause Mortality Rate(1 year and annually through 10 years)
Percent of Participants With New Permanent Pacemaker Implantation at 30 Days Post-procedure.(30 days)
Percent of Participants Who Experience a Myocardial Infarction at 30 Days Post-procedure.(30 days)
Percent pf Participants With Valve-Related Dysfunction Requiring Repeat Procedure at 30 Days Post-procedure.(30 days)
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Paravalvular Prosthetic Regurgitation at 30 Days(30 days)
New York Heart Association (NYHA) Functional Classification at Baseline and 30 Days(30 days)
Percent of Participants With a Repeat Hospitalization for Aortic Valve Disease at 30 Days Post-procedure.(30 days)
Percent of Participants With Prosthetic Valve Endocarditis at 30 Days Post-procedure.(30 days)
Percent of Participants With a Repeat Hospitalization for Ascending Aorta Disease at 30 Days Post-procedure.(30 days)
Hemodynamic Performance Metrics by Doppler Echocardiography: Effective Orifice Area Reported as Mean Average at Baseline and 30 Days.(30 days)
Change in Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy (KCCQ) Instrument at Baseline and 30 Days(30 days)
Health-related Quality of Life (QoL) as Assessed by European QoL (EQ-5D) at Baseline and 30 Days.(30 days)