The Medtronic CoreValve Evolut R US Clinical Study
Transcatheter aortic valve implantation (TAVI) has become a routine treatment option at specialized heart centers treating patients with severe aortic stenosis who are at high risk for surgical aortic valve replacement (SAVR). Medtronic has developed modifications to the Medtronic CoreValve System Transcatheter Aortic Valve frame and delivery catheter system to enable recapture of the device before it is fully released from the delivery system. These modifications are incorporated in the CoreValve Evolut R System.
The purpose of the study is to evaluate the safety and efficacy of the CoreValve Evolut R System in patients with severe symptomatic aortic stenosis who are considered at high through extreme risk for surgical aortic valve replacement.
This is a prospective, single arm, historical controlled, multi-center study. This study will involve no more than 250 subjects in up to 25 sites. The study population includes males and females with severe symptomatic aortic stenosis who are considered at high through extreme risk for surgical aortic valve replacement. Subjects will be followed up to 5 years following implantation.
Study endpoints are safety endpoints and efficacy endpoints. Safety endpoints are: All-cause mortality rate, stroke (disabling) rate, incidence of permanent pacemaker implant rate at 30 days. Efficacy endpoints are: Device success rate, Resheath and recapture success rate, percent of subjects with mild prosthetic regurgitation at early post-implant, hemodynamic performance metrics at 30 days.
Statistics/analysis: Subjects who are taken to the procedure room for implantation will comprise the study population evaluated for the study objectives and associated endpoints. An initial analysis will be performed when both of the following conditions are met:
1. The first 150 consecutive implanted subjects have completed their 30 day follow-up.
2. A total of 25 resheath or recapture attempts inclusive of all valve sizes, have been performed.
The final analysis will be performed after a minimum of 150 subjects but no greater than 250 subjects are implanted with the study device and followed for 5 years.
All endpoints are descriptive and no statistical hypothesis test will be performed.
Transluminal Aortic Balloon Valvuloplasty Registry (TAB-R)
The study is an open-label observational study involving a minimum of 10 centers. A minimum
of 100 patients, including a minimum of 30 stand-alone balloon aortic valvuloplasty (BAV)
treatment patients, will be enrolled. Enrollment will continue until all 3 of these
conditions are met.
BAV-only patients will be followed through a 6-month post-treatment telephone follow up.
Patients treated with the V8 device for BAV as a bridge to transcatheter aortic valve
replacement (TAVR) or surgical aortic valve replacement (SAVR) or as an intraprocedural
predilatation prior to TAVR, will exit the study at the time of the TAVR or SAVR implant or
at 6 months post-BAV treatment, whichever comes first.
Medtronic CoreValve® U.S. Expanded Use Study
The primary objective of the study is to evaluate the safety and effectiveness of the
Medtronic CoreValve® System (MCS) in a subset of subjects excluded from the U.S. Extreme
Risk Pivotal Trial population due to one or more additional co-morbidities, as measured by a
composite of all-cause death or major stroke at 12 months, in the treatment of symptomatic
severe aortic stenosis in subjects necessitating aortic valve replacement. Subjects enrolled
in this study have a predicted operative mortality or serious, irreversible morbidity risk
of ≥50% at 30 days associated with surgical aortic valve replacement.
Neuroprotection In Patients Undergoing Aortic Valve Replacement
This is a multicenter randomized trial in which patients diagnosed with calcific aortic
stenosis (AS) with planned AVR will be randomized to 1) the treatment arm of the Edwards Life
Science filter and cannula or the filter as a stand alone with any cannula or 2) to the
treatment arm of the CardioGard cannula versus 3) standard care in a 1:1:1 ratio.
Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial
The PORTICO IDE trial will include approximately 758 randomized subjects at up to 70
investigational sites. The study is powered to analyze the high risk cohort and extreme risk
cohort together against a commercially available control for the primary safety and
effectiveness endpoints. In addition, data for each cohort will be analyzed separately in a
A minimum of two (2) and up to three (3) roll-in patients per primary implanting physician
will be allowed. These roll-in subjects will be added to a Roll-in Registry. In addition, up
to 100 subjects may be enrolled in a Valve-in-Valve registry. Implanting physicians with
prior Portico experience and with a minimum of 3 implants in the last 6 months will not be
required to include roll-in patients.
Registry data will not be included in the randomized cohort analysis, but will be analyzed
and presented separately.
The FlexNav study will be conducted as a separate arm of the PORTICO IDE trial and will
include 100 high or extreme risk patients. Safety data for the FlexNav™ Delivery System will
be summarized and descriptively compared to the first-generation Portico Delivery System.
Following completion of enrollment in the randomized cohort, subjects will be eligible for
enrollment in the Portico IDE Continued Access Protocol (CAP) Study.
The sponsor will submit a final clinical report for combined risk cohorts as enrollment and
follow-up is completed according to the protocol.