Evolut™ EXPAND TAVR II Pivotal Trial
Evolut™ EXPAND TAVR II Pivotal Trial
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Clinical Trial Information
Trial Contact: Marquart, Vashnie; Ngo, George M.; Rodriguez, Jessica Marie
Trial Phone: 321-843-1037 ; 3218439657 ; 3218413270
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IRB No: W23.255.12
Protocol Abbrev: ™ EXPAND TAVR II
Principal Investigator: Deepak Pathe Vivek, MD
Age Group: Adult
Secondary Protocol No: D00411092
Treatment: The index TAVR procedure is performed according to the Instructions for Use (IFU) and standard procedures of the implant team. For sites in the United States and Japan, the local heart valve team’s interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-procedural aspects of the TAVR procedure. Procedural aspects specific to the Medtronic TAVR system should be performed according to the IFU. Transfemoral access is required for the TAVR implant. Valve deployment should be performed using the cusp overlap technique71 unless patient related factors prevent using this procedural technique
Therapies Involved: Procedural
ClinicalTrials.gov ID: NCT05149755
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Objective
The purpose of this trial is to evaluate the safety and effectiveness of the Medtronic Evolut PRO+ and
Evolut FX TAVR system and guideline-directed management and therapy (GDMT) compared to GDMT in
patients with moderate, symptomatic AS. Data will be used to support regulatory submissions to expand
the current indications for the Evolut PRO+ and Evolut FX TAVR system to include patients with
moderate, symptomatic AS. -
Key Eligibility
The trial population includes males and females ≥ 65 years of age
