CoreValve Evolut Pro Prospective Registry

Aortic Stenosis Clinical Trial

Official title:

CoreValve Evolut Pro Prospective Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03423459
• Other study ID #: EPROMPT
• Status: Active, not recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis

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