Clinical trial NCT04902053: INSPIRIS RESILIA Aortic Valve, Valve-in-Valve Surveillance Study
Official title: INSPIRIS RESILIA Aortic Valve, Valve-in-Valve Surveillance Study
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Aortic Valve Replacement
Keywords: INVIVITY
RESILIA
INSPIRIS
Valve in Valve
TAVR
Aortic Transcatheter
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2021-05-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects previously implanted with INSPIRIS RESILIA Model 11500A and are undergoing planned valve-in-valve treatment

Brief summary: The primary objective of the INSPIRIS RESILIA Aortic Valve-in-valve (ViV) Surveillance Study ("the Study") is to capture Adverse Event information and valve measurement data from dysfunctional INSPIRIS RESILIA aortic valves before and after Valve-in-valve (ViV) treatment.

Detailed description: This is a single-arm observational study which includes both prospective and retrospective data.

At least fifty (50) Subjects enrolled prospectively prior to the ViV procedure, or retrospectively after the ViV procedure (within 37 days post-ViV procedure) with dysfunctional 19mm-25mm INSPIRIS aortic valves, will participate in this study.

All subjects will be followed for up to 1 month after the TAVR ViV procedure.

Eligibility criteria: Inclusion Criteria:

Subjects must meet all of the following Inclusion Criteria:

1. 18 years or older at the time of the TAVR ViV treatment
2. Has an INSPIRIS RESILIA aortic valve implanted in the aortic position confirmed to be size 19mm, 21mm, 23mm or 25mm
3. A ViV procedure using an Edwards transcatheter aortic heart valve (TAVR) has been scheduled; or completed within 37 days from time of consent
4. The participant agrees to attend a follow-up assessment at 1 month post ViV procedure
5. The participant provides written informed consent prior to the post-ViV procedure CT scan

Exclusion Criteria:

Subjects must not meet any of the following Exclusion Criteria:

1. The INSPIRIS RESILIA aortic valve size is

   * Unconfirmed, or
   * Confirmed to be 27mm or 29mm
2. Prior re-interventions have been performed on the INSPIRIS RESILIA aortic valve
3. The INSPIRIS RESILIA aortic valve has been subjected to balloon aortic valvuloplasty (BAV) prior to the baseline quantitative area measurement of the valve area
4. The Subject is pregnant or desires to become pregnant within 40 days of the ViV procedure
5. Subjects with a known contraindication or hypersensitivity to contrast media that cannot be adequately pre-medicated per hospital guidelines

Primary outcomes:
measure: Subject's Occurrence Rate of the Composite Safety Endpoint
timeFrame: Events occurring within 30 days of valve-in-valve procedure
measure: Subject's Occurrence Rate of Valve Malpositioning
timeFrame: Events occurring within 30 days of valve-in-valve procedure
measure: Subject's INSPIRIS RESILIA Valve Expansion Post Valve in Valve Procedure Compared to Baseline
timeFrame: Day 30, compared to baseline
Secondary outcomes:
measure: Subject's Occurrence Rate of Reportable Adverse Events
timeFrame: Events occurring within 30 days of valve-in-valve procedure
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Indianapolis
country: United States
facility: St. Vincent Hospital
state: Indiana
city: New York
country: United States
facility: Nyph/Cumc
state: New York
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Northwestern University
name: Douglas Johnston, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: