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CoreValve Evolut Pro Registry

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ClinicalTrials.gov Identifier: NCT03423459
Recruitment Status : Recruiting
First Posted : February 6, 2018
Last Update Posted : February 6, 2018
Sponsor:
Collaborator:
Medtronic Cardiovascular
Information provided by (Responsible Party):
Medstar Health Research Institute

Tracking Information
First Submitted Date January 18, 2018
First Posted Date February 6, 2018
Last Update Posted Date February 6, 2018
Actual Study Start Date January 18, 2018
Estimated Primary Completion Date January 18, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 30, 2018)
  • Device success: [ Time Frame: 30 days ]
    Absence of procedural mortality Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient<20 mm Hg or peak velocity<3 m/s, AND no moderate or severe prosthetic valve regurgitation)
  • All Cause Mortality [ Time Frame: 30 days ]
    all causes of death
  • All Stroke (disabling and non-disabling [ Time Frame: 30 days ]
    Stroke will evaluated using the VARC-2 definition
  • Life Threatening Bleeding [ Time Frame: 30 Days ]
    Life Threatening Bleeding will be evaluated using the VARC-2 definition
  • Acute Kidney Injury Stage 2 or 3 [ Time Frame: 30 days ]
    AKI will be evaluated using the VARC-2 definition of Stage 2 or 3 AKI
  • Coronary Artery Obstruction requiring intervention [ Time Frame: 30 days ]
    This will be assessed if by noting whether the patient has a re intervention
  • Major Vascular Complication [ Time Frame: 30 days ]
    Major Vascular Complication will be evaluated using the VARC-2 definition of Major Vascular Complication
  • Valve - related Dysfunction [ Time Frame: 30 Days ]
    Valve related dysfunction will be evaluated by determining whether the subject has a repeat procedure such as a BAV, TAVI, or SAVR
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 30, 2018)
  • Prosthetic valve dysfunction [ Time Frame: 1 year ]
    Mean aortic valve gradient ≥20 mm Hg
  • Prosthetic valve dysfunction [ Time Frame: 1 year ]
    Moderate-severe transvalvular aortic regurgitation as determined by the echo core lab
  • Prosthetic valve dysfunction [ Time Frame: 1 year ]
    Abnormal leaflet thickening on CT as determined by the CT Core lab
  • Prosthetic valve dysfunction [ Time Frame: 1 year ]
    Decreased leaflet mobility on CT as determined by the CT Core lab
  • Prosthetic valve dysfunction [ Time Frame: 1 year ]
    Leaflet thrombosis on CT as determined by the CT Core lab
  • Reduction in PVL [ Time Frame: Discharge thru to 1 year ]
    This will be evaluated by echo core lab findings
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title CoreValve Evolut Pro Registry
Official Title CoreValve Evolut Pro Registry
Brief 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.
Detailed Description

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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population This study is a prospective registry of subjects with symptomatic severe aortic stenosis undergoing TAVR with a commercially-approved self-expanding transcatheter heart valve. A subgroup of subjects will undergo additional research contrast-enhanced 4D CT at 30-60 days after TAVR. Otherwise, all additional test and TAVR implantation procedures are as per standard of care.
Condition Aortic Stenosis
Intervention Device: TAVR
Transcatheter Aortic Valve Replacement
Study Groups/Cohorts
  • 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.
    Intervention: Device: TAVR
  • 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.
    Intervention: Device: TAVR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 30, 2018)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 18, 2021
Estimated Primary Completion Date January 18, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Roshni Bastian, MPH 202-877-7752 roshni.s.bastian@medstar.net
Contact: Rebecca Torguson, MPH 202-877-2194 rebecca.torguson@medstar.net
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03423459
Other Study ID Numbers EPROMPT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Medstar Health Research Institute
Study Sponsor Medstar Health Research Institute
Collaborators Medtronic Cardiovascular
Investigators Not Provided
PRS Account Medstar Health Research Institute
Verification Date January 2018