NCT04091048
Completed
Not Applicable
Optimize PRO Transcatheter Aortic Valve Replacement Post Market Study
Medtronic Cardiovascular97 sites in 7 countries1,127 target enrollmentSeptember 16, 2019
ConditionsSymptomatic Aortic Stenosis
Overview
- Phase
- Not Applicable
- Intervention
- Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum)
- Conditions
- Symptomatic Aortic Stenosis
- Sponsor
- Medtronic Cardiovascular
- Enrollment
- 1127
- Locations
- 97
- Primary Endpoint
- All-cause Mortality or All-stroke
- Status
- Completed
- Last Updated
- 3 months ago
Overview
Brief Summary
The purpose of this study is to collect clinical evidence on valve performance and procedural outcomes associated with an "optimized" TAVR care pathway and post-TAVR conduction disturbance pathway while using the Evolut™ PRO and Evolut™ PRO+ devices.
The purpose of the addendum is to collect post-market clinical evidence on valve performance and procedural outcomes associated with the Evolut FX Device.
Detailed Description
This is a post market, multi-center (sites in US/CAN/EMEA/ANZ), prospective, non-randomized study. The addendum is a post market, multi-center (sites in US only), prospective, non-randomized study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Acceptable candidate for treatment with the Evolut™ PRO or Evolut™ PRO+ system (FX system for the addendum where applicable) in accordance with the Instructions for Use and local regulations;
- •Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater;
- •Subject and the treating physician agree that the subject will return for all required post procedure follow-up visits;
- •Anatomically suitable for transfemoral TAVR with the Medtronic TAVR system;
- •Subject meets the legal minimum age to provide Informed Consent based on local regulatory requirements.
Exclusion Criteria
- •Contraindicated for treatment with the Evolut™ PRO or Evolut™ PRO+ or FX system (where applicable) in accordance with the Instructions for Use
- •Anatomically not suitable for the Evolut™ PRO or Evolut™ PRO+ or FX system (where applicable);
- •Previous aortic valve replacement
- •Reduced ventricular function with left ventricular ejection fraction (LVEF) \<35% as measured by resting echocardiogram;
- •Frailty assessments identify:
- •Subject is \<80 years of age and three or more of the following apply; OR subject is \> 80 years of age and two or more of the following apply
- •Wheelchair bound
- •Resides in an institutional care facility (e.g. nursing home, skilled care center)
- •Body Mass Index \<20kg/m2
- •Grip strength \<16kg
Arms & Interventions
Primary Cohort
Intervention: Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum)
Outcomes
Primary Outcomes
All-cause Mortality or All-stroke
Time Frame: 30 days post procedure
All-cause mortality or all-stroke at 30 days.
Secondary Outcomes
- Aortic Regurgitation (AR)(Through discharge up to 7 days post index procedure.)
- Pacemaker Implantation or Worsening Conduction Disturbance(30 days)
- Length of Stay(Through discharge up to 7 days post index procedure.)
- Depth of Implant (Evolut FX Only)(30 days)
- Canting (Evolut FX Addendum Only)(30 Days)
Study Sites (97)
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