Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03423459
Other study ID # EPROMPT
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 18, 2018
Est. completion date December 31, 2024

Study information

Verified date May 2023
Source Medstar Health Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 200
Est. completion date December 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers
Gender All
Age group 50 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
TAVR
Transcatheter Aortic Valve Replacement

Locations

Country Name City State
United States Medstar Union Memorial Hospital Baltimore Maryland
United States MedStar Washington Hospital Center Washington District of Columbia

Sponsors (2)

Lead Sponsor Collaborator
Medstar Health Research Institute Medtronic Cardiovascular

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Device success: 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) 30 days
Primary All Cause Mortality all causes of death 30 days
Primary All Stroke (disabling and non-disabling Stroke will evaluated using the VARC-2 definition 30 days
Primary Life Threatening Bleeding Life Threatening Bleeding will be evaluated using the VARC-2 definition 30 Days
Primary Acute Kidney Injury Stage 2 or 3 AKI will be evaluated using the VARC-2 definition of Stage 2 or 3 AKI 30 days
Primary Coronary Artery Obstruction requiring intervention This will be assessed if by noting whether the patient has a re intervention 30 days
Primary Major Vascular Complication Major Vascular Complication will be evaluated using the VARC-2 definition of Major Vascular Complication 30 days
Primary Valve - related Dysfunction Valve related dysfunction will be evaluated by determining whether the subject has a repeat procedure such as a BAV, TAVI, or SAVR 30 Days
Secondary Prosthetic valve dysfunction #1 Mean aortic valve gradient =20 mm Hg 1 year
Secondary Prosthetic valve dysfunction #2 Moderate-severe transvalvular aortic regurgitation as determined by the echo core lab 1 year
Secondary Prosthetic valve dysfunction #3 Abnormal leaflet thickening on CT as determined by the CT Core lab 1 year
Secondary Prosthetic valve dysfunction #4 Decreased leaflet mobility on CT as determined by the CT Core lab 1 year
Secondary Prosthetic valve dysfunction Leaflet thrombosis on CT as determined by the CT Core lab 1 year
Secondary Reduction in PVL This will be evaluated by echo core lab findings Discharge thru to 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT04310046 - Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial N/A
Completed NCT03332745 - Mechanism of Decompensation Evaluation - Aortic Stenosis
Recruiting NCT06008080 - Post-Market Clinical Follow Up Study With Navitor Valve
Recruiting NCT06055751 - Long Term Evaluation of Cardiac Arrhythmias After Transcatheter Aortic Valve Implantation -The LOCATE Registry
Active, not recruiting NCT04815785 - Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis N/A
Terminated NCT02202434 - Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement N/A
Recruiting NCT03029026 - The Role of Occult Cardiac Amyloid in the Elderly With Aortic Stenosis.
Active, not recruiting NCT02903420 - A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan) N/A
Completed NCT02629328 - CardioCel Tri-leaflet Repair Study N/A
Completed NCT02306226 - Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry
Completed NCT01676727 - ADVANCE Direct Aortic Study
Withdrawn NCT01648309 - Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation N/A
Completed NCT01422044 - Risk Prediction in Aortic Stenosis N/A
Withdrawn NCT00774657 - Ventricular Remodeling In Patients With Aortic Stenosis Assessed Echocardiography N/A
Terminated NCT00535899 - Speckle Tracking Imaging in Patients With Low Ejection Fraction Aortic Stenosis (SPArKLE-AS) N/A
Terminated NCT05070130 - OpSens PRIME CLASS
Completed NCT03314857 - China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population N/A
Completed NCT04157920 - Impact of Predilatation Between Self-expanding Valves N/A
Enrolling by invitation NCT06212050 - Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis
Recruiting NCT05893082 - Multicenter Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR N/A