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Trial record 1 of 3 for:    MedStar Health | Recruiting Studies | "Aortic Valve Stenosis"
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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

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.

Condition or disease Intervention/treatment
Aortic Stenosis Device: TAVR

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: CoreValve Evolut Pro Registry
Actual Study Start Date : January 18, 2018
Estimated Primary Completion Date : January 18, 2020
Estimated Study Completion Date : January 18, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Device: TAVR
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.
Device: TAVR
Transcatheter Aortic Valve Replacement




Primary Outcome Measures :
  1. 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)

  2. All Cause Mortality [ Time Frame: 30 days ]
    all causes of death

  3. All Stroke (disabling and non-disabling [ Time Frame: 30 days ]
    Stroke will evaluated using the VARC-2 definition

  4. Life Threatening Bleeding [ Time Frame: 30 Days ]
    Life Threatening Bleeding will be evaluated using the VARC-2 definition

  5. 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

  6. Coronary Artery Obstruction requiring intervention [ Time Frame: 30 days ]
    This will be assessed if by noting whether the patient has a re intervention

  7. Major Vascular Complication [ Time Frame: 30 days ]
    Major Vascular Complication will be evaluated using the VARC-2 definition of Major Vascular Complication

  8. 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


Secondary Outcome Measures :
  1. Prosthetic valve dysfunction [ Time Frame: 1 year ]
    Mean aortic valve gradient ≥20 mm Hg

  2. Prosthetic valve dysfunction [ Time Frame: 1 year ]
    Moderate-severe transvalvular aortic regurgitation as determined by the echo core lab

  3. Prosthetic valve dysfunction [ Time Frame: 1 year ]
    Abnormal leaflet thickening on CT as determined by the CT Core lab

  4. Prosthetic valve dysfunction [ Time Frame: 1 year ]
    Decreased leaflet mobility on CT as determined by the CT Core lab

  5. Prosthetic valve dysfunction [ Time Frame: 1 year ]
    Leaflet thrombosis on CT as determined by the CT Core lab

  6. Reduction in PVL [ Time Frame: Discharge thru to 1 year ]
    This will be evaluated by echo core lab findings



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03423459


Contacts
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Contact: Roshni Bastian, MPH 202-877-7752 roshni.s.bastian@medstar.net
Contact: Rebecca Torguson, MPH 202-877-2194 rebecca.torguson@medstar.net

Locations
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United States, District of Columbia
MedStar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Roshni S Bastian, MPH    202-877-7752    roshni.s.bastian@medstar.net   
Principal Investigator: Ron Waksman, MD         
Sponsors and Collaborators
Medstar Health Research Institute
Medtronic Cardiovascular

Additional Information:

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Responsible Party: Medstar Health Research Institute
ClinicalTrials.gov Identifier: NCT03423459     History of Changes
Other Study ID Numbers: EPROMPT
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction