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Transcatheter Aortic Valve Replacement (TAVR)

Non-CT Cohort for Aortic Stenosis

N/A
Waitlist Available
Research Sponsored by Medstar Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Summary

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.

Eligible Conditions
  • Aortic Stenosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acute Kidney Injury Stage 2 or 3
All Cause Mortality
All Stroke (disabling and non-disabling
+5 more
Secondary study objectives
Prosthetic valve dysfunction
Prosthetic valve dysfunction #1
Prosthetic valve dysfunction #2
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Non-CT CohortExperimental Treatment1 Intervention
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.
Group II: CT CohortExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAVR
2017
N/A
~6010

Find a Location

Who is running the clinical trial?

Medstar Health Research InstituteLead Sponsor
193 Previous Clinical Trials
118,034 Total Patients Enrolled
Medtronic CardiovascularIndustry Sponsor
75 Previous Clinical Trials
35,973 Total Patients Enrolled
~26 spots leftby Sep 2025
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