CoreValve Evolut Pro Prospective Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-18

Study Completion Date

2024-12-31

Brief Summary

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The primary objective of this study is to evaluate the real-world performance of the CoreValve Evolut PRO transcatheter aortic valve, including leaflet function, in a prospective observational registry.

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Detailed Description

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The CoreValve Evolut PRO transcatheter aortic valve was approved by the FDA in March 2017 to treat patients with symptomatic severe aortic stenosis at high or extreme risk for open heart surgery, and in July 2017 for intermediate risk patients. This latest generation device features an outer wrap to improve annular sealing and reduce paravalvular leak.

In this observational study, baseline demographic and imaging characteristics, procedural details and clinical outcomes of patients undergoing transcatheter aortic valve replacement with the CoreValve Evolut PRO will be prospectively collected into a registry database. The institutional Heart Team will select patients according to standard practice.

Conditions

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Aortic Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CT Cohort

1. Compare the rate of ≥mild PVL in patients with none/mild versus moderate/severe LVOT calcification.
2. Comparison of the rate of PPM implantation in patients with none/mild versus moderate/severe LVOT calcification.
3. Determine how the Evolut PRO conforms to LVOT calcification.
4. Compare the impact of LVOT calcification on the implantation depth of the Evolut PRO.
5. Analyze the interaction and geometry of the Evolut PRO in patients with moderate/severe LVOT calcification.
6. Assess for leaflet thickening, subclinical leaflet thrombosis and/or restricted leaflet motion 30-60 days after TAVR.

TAVR

Intervention Type DEVICE

Transcatheter Aortic Valve Replacement

Non-CT Cohort

1. Compare the rate of ≥mild PVL with the Evolut PRO with a propensity score matched cohort of historical control subjects who underwent TAVR with the Evolut R and/or CoreValve within the MedStar Health System.
2. Determine which features of LVOT calcification (volume, location relative to aortic annulus and sinuses, prominence into the LVOT lumen) predict ≥mild PVL.
3. Determine which features of LVOT calcification (volume, location relative to aortic annulus and sinuses, prominence into the LVOT lumen) predict PPM implantation.

TAVR

Intervention Type DEVICE

Transcatheter Aortic Valve Replacement

Interventions

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TAVR

Transcatheter Aortic Valve Replacement

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Symptomatic severe aortic stenosis
2. Intermediate, high or extreme surgical risk
3. The institutional Heart Team determines that transcatheter aortic valve replacement with an Evolut Pro device is appropriate

Exclusion Criteria

1. Subject unable or unwilling to give informed consent
2. For subjects in the CT arm only, renal function precluding the administration of iodinated contrast for cardiac CT (eGFR \< 30 ml/min/1.73m2). An exception to this exclusion criterion is made if the subject is established on renal replacement therapy and is therefore able to receive intravenous iodinated contrast media.
3. Pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No