Aortic Valve ReplacementINVIVITYNCT04902053
INSPIRIS RESILIA Aortic Valve, Valve-in-Valve Surveillance Study
An observational study of Aortic Valve Replacement, run by Edwards Lifesciences at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Replacement
- What is being tested?
- Subjects previously implanted with INSPIRIS RESILIA Model 11500A and are undergoing planned valve-in-valve treatment.
- How many people
- 50 participants
- Where
- 7 sitesUnited States
- Study dates
- Jun 2028to Jan 2031
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects previously implanted with INSPIRIS RESILIA Model 11500A and are undergoing planned valve-in-valve treatment
Who may be able to join
- Subjects must meet all of the following Inclusion Criteria:
- 18 years or older at the time of the TAVR ViV treatment
- Has an INSPIRIS RESILIA aortic valve implanted in the aortic position confirmed to be size 19mm, 21mm, 23mm or 25mm
- A ViV procedure using an Edwards transcatheter aortic heart valve (TAVR) has been scheduled; or completed within 37 days from time of consent
- The participant agrees to attend a follow-up assessment at 1 month post ViV procedure
- The participant provides written informed consent prior to the post-ViV procedure CT scan
Who cannot join
- Subjects must not meet any of the following Exclusion Criteria:
- The INSPIRIS RESILIA aortic valve size is
- Unconfirmed, or
- Confirmed to be 27mm or 29mm
- Prior re-interventions have been performed on the INSPIRIS RESILIA aortic valve
- The INSPIRIS RESILIA aortic valve has been subjected to balloon aortic valvuloplasty (BAV) prior to the baseline quantitative area measurement of the valve area
- The Subject is pregnant or desires to become pregnant within 40 days of the ViV procedure
- Subjects with a known contraindication or hypersensitivity to contrast media that cannot be adequately pre-medicated per hospital guidelines
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
University of Florida
Gainesville, Florida, 32611
St. Vincent Hospital
Indianapolis, Indiana, 46290
University of Southern California
Los Angeles, California, 90033
Nyph/Cumc
New York, New York, 10032
AdventHealth Orlando
Orlando, Florida, 32803
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the 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.
- Conditions
- Aortic Valve Replacement
- Being tested
- Subjects previously implanted with INSPIRIS RESILIA Model 11500A and are undergoing planned valve-in-valve treatment.
- Keywords
- INVIVITY, RESILIA, INSPIRIS, Valve in Valve, TAVR, Aortic Transcatheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subjects previously implanted with INSPIRIS RESILIA Model 11500A and are undergoing planned valve-in-valve treatment.Diagnostic test
Designed to capture Adverse Event information and valve measurement data from dysfunctional INSPIRIS RESILIA aortic valves before and after Valve-in-valve (ViV) treatment.
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject's Occurrence Rate of the Composite Safety Endpoint
The primary safety endpoint is a composite endpoint defined as all-cause mortality, all stroke (disabling and non-disabling), life-threatening bleeding, new requirement for dialysis, coronary artery compression or obstruction, major vascular complication, and valve-related dysfunction requiring reintervention.
Data will be reported as the number (and percent) of subjects who experience an event divided by the number of enrolled subjects times 100.
Measured: Events occurring within 30 days of valve-in-valve procedure
Subject's Occurrence Rate of Valve Malpositioning
Valve malpositioning includes all instances of ViV-TAVR migration, embolization, and valve recapture or retrieval.
Data will be reported as the number (and percent) of subjects who experience an event divided by the number of enrolled subjects times 100.
Measured: Events occurring within 30 days of valve-in-valve procedure
Subject's INSPIRIS RESILIA Valve Expansion Post Valve in Valve Procedure Compared to Baseline
A primary effectiveness endpoint is the expansion, measured in mm^2, of INSPIRIS valve for sizes 19mm-25mm, following the Edwards transcatheter aortic valve implantation.
Measured: Day 30, compared to baseline
Secondary outcomes (1)
Subject's Occurrence Rate of Reportable Adverse Events
Reportable Adverse Events mirroring those being reported to the STS/ACC TVT Registry.
Data will be reported as the number (and percent) of subjects who experience an event divided by the number of enrolled subjects times 100.
Measured: Events occurring within 30 days of valve-in-valve procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study startJun 2028 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionJan 2031 (estimated)
Why it stopped: Lack of enrollment. Study will be restarted when there is sufficient INSPIRIS Valve in Valve case volume to support enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve ReplacementStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Douglas Johnston, MD, FACS, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902053
- Sponsor's protocol ID
- 2017-12
- Acronym
- INVIVITY
- Status last verified
- Jul 2026
- First submitted
- 12 May 2021
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INSPIRIS RESILIA Aortic Valve, Valve-in-Valve Surveillance Study
- ClinicalTrials.gov ID
- NCT04902053
- Acronym / sponsor ID
- INVIVITY / 2017-12
- Conditions
- Aortic Valve Replacement
- Keywords
- INVIVITY, RESILIA, INSPIRIS, Valve in Valve, TAVR, Aortic Transcatheter
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Lack of enrollment. Study will be restarted when there is sufficient INSPIRIS Valve in Valve case volume to support enrollment.
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- Jun 2028 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects previously implanted with INSPIRIS RESILIA Model 11500A and are undergoing planned valve-in-valve treatment
Key inclusion criteria (6 listed)
- 18 years or older at the time of the TAVR ViV treatment
- Has an INSPIRIS RESILIA aortic valve implanted in the aortic position confirmed to be size 19mm, 21mm, 23mm or 25mm
- A ViV procedure using an Edwards transcatheter aortic heart valve (TAVR) has been scheduled; or completed within 37 days from time of consent
- The participant agrees to attend a follow-up assessment at 1 month post ViV procedure
- The participant provides written informed consent prior to the post-ViV procedure CT scan
Key exclusion criteria (8 listed)
- The INSPIRIS RESILIA aortic valve size is
- Prior re-interventions have been performed on the INSPIRIS RESILIA aortic valve
- The INSPIRIS RESILIA aortic valve has been subjected to balloon aortic valvuloplasty (BAV) prior to the baseline quantitative area measurement of the valve area
- The Subject is pregnant or desires to become pregnant within 40 days of the ViV procedure
- Subjects with a known contraindication or hypersensitivity to contrast media that cannot be adequately pre-medicated per hospital guidelines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subjects previously implanted with INSPIRIS RESILIA Model 11500A and are undergoing planned valve-in-valve treatment.Designed to capture Adverse Event information and valve measurement data from dysfunctional INSPIRIS RESILIA aortic valves before and after Valve-in-valve (ViV) treatment. | Diagnostic test | – |
Primary outcome
Subject's Occurrence Rate of the Composite Safety Endpoint
Time frame: Events occurring within 30 days of valve-in-valve procedure
The primary safety endpoint is a composite endpoint defined as all-cause mortality, all stroke (disabling and non-disabling), life-threatening bleeding, new requirement for dialysis, coronary artery compression or obstruction, major vascular complication, and valve-related dysfunction requiring reintervention. Data will be reported as the number (and percent) of subjects who experience an event divided by the number of enrolled subjects times 100.
Subject's Occurrence Rate of Valve Malpositioning
Time frame: Events occurring within 30 days of valve-in-valve procedure
Valve malpositioning includes all instances of ViV-TAVR migration, embolization, and valve recapture or retrieval. Data will be reported as the number (and percent) of subjects who experience an event divided by the number of enrolled subjects times 100.
Subject's INSPIRIS RESILIA Valve Expansion Post Valve in Valve Procedure Compared to Baseline
Time frame: Day 30, compared to baseline
A primary effectiveness endpoint is the expansion, measured in mm^2, of INSPIRIS valve for sizes 19mm-25mm, following the Edwards transcatheter aortic valve implantation.
1 secondary outcome
Subject's Occurrence Rate of Reportable Adverse Events
Time frame: Events occurring within 30 days of valve-in-valve procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be available to other researchers.
Related trials for Aortic Valve Replacement
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
RecruitingObservational study
Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Active, not recruiting
Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients
Aortic Valve Stenosis
Recruiting
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial
Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas Johnston, MD, FACS principal investigator
Northwestern University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Replacement, run by Edwards Lifesciences at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject's Occurrence Rate of the Composite Safety Endpoint (time frame: Events occurring within 30 days of valve-in-valve procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.