Aortic Valve ReplacementRESILIENCENCT03680040
RESILIENCE Trial: Evaluation of the Durability of Aortic Bioprostheses/Valves With RESILIA Tissue in Subjects Under 65
An observational study of Aortic Valve Replacement, run by Edwards Lifesciences at 10 sites in United States.
Trial summary
The objective of this observational trial is to determine time to valve failure due to valve deterioration requiring re-intervention and collect/investigate early potential predictors of valve durability (e.g., calcification and hemodynamic deterioration) in RESILIA tissue valves. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Aortic Valve Replacement
- What is being tested?
- Subjects previously implanted with a RESILIA aortic tissue valve.
- How many people
- 110 participants
- Where
- 10 sitesUnited States
- Study dates
- 5 Nov 2018to 13 Feb 2024
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Subjects previously implanted with a RESILIA aortic tissue valve.
Who may be able to join
- 18 years or older
- Subject currently has an Edwards pericardial aortic bioprosthesis with RESILIA tissue
- Provides voluntary written informed consent prior to the first trial related procedure
- Subject agrees to attend follow-up assessments as specified in the protocol
Who cannot join
- Age 65 years or older at time of aortic valve replacement
- The Subject is pregnant or planning to become pregnant at the time of screening
- Re-intervention required on the bioprosthetic aortic valve prior to screening
- Active endocarditis or history of endocarditis on bioprosthetic aortic valve
- Estimated life expectancy <24 months
- Subjects with history of or current renal failure requiring dialysis
- Altered mineral metabolism (hyperparathyroidism, parathyroid tumors)
- Has prior organ transplant or is currently an organ transplant candidate
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Maryland, Baltimore
Baltimore, Maryland, 21201
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
University of Florida - Shands Hospital
Gainesville, Florida, 32608
Baylor College of Medicine - St. Luke's Hospital
Houston, Texas, 77030
University of Southern California
Los Angeles, California, 90033
Pinnacle Health
Mechanicsburg, Pennsylvania, 17050
Columbia University Medical Center-NY Presbyterian Hospital
New York, New York, 10032
Weill Cornell - NYC
New York, New York, 10065
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
The Heart Hospital of Baylor Plano
Plano, Texas, 75093
About this study
Official title: Prospective Non-randomized Single Arm Multi-center Evaluation of the Durability of Aortic Bioprostheses/Valves With RESILIA Tissue in Subjects Under 65 (RESILIENCE Trial)
The objective of this observational trial is to determine time to valve failure due to valve deterioration requiring re-intervention and collect/investigate early potential predictors of valve durability (e.g., calcification and hemodynamic deterioration) in RESILIA tissue valves.
Read the detailed description
Multicenter, prospective, non-randomized, single-arm, observational trial. Subjects will be evaluated at 5, 7, 9, and 11 years post-implant. Up to two hundred fifty (250) total subjects at up to fifteen (15) investigational sites will be enrolled.
- Conditions
- Aortic Valve Replacement
- Being tested
- Subjects previously implanted with a RESILIA aortic tissue valve.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subjects previously implanted with a RESILIA aortic tissue valve.Diagnostic test
Subjects to undergo multi-slice computed tomography and echocardiogram to assess predictors of valve durability in previously implanted Edwards aortic valves with RESILIA tissue.
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to bioprosthetic valve failure due to valve deterioration
Time to bioprosthetic valve failure due to valve deterioration is defined as subject requiring valve re-intervention (redo surgery, valve-in-valve) or confirmed study valve-related death.
Measured: 11 years post-implant
Secondary outcomes (1)
Collection of early possible predictors of valve failure including leaflet calcification and morphological/hemodynamic valve deterioration
- Quantification of valve leaflet calcification via core lab evaluated multi-slice computed tomography (MSCT)
- Hemodynamic performance of the valve and evaluation for possible morphological/hemodynamic valve deterioration confirmed by core lab evaluation of echo-cardiography
Measured: 5, 7, 9, and 11 years post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start5 Nov 2018
- Primary completion13 Feb 2024
- Study completion13 Feb 2024
Why it stopped: Low 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Bavaria, MD, Principal investigator, Organizational Affiliation: Hospital of the University of PennsylvaniaLars Svensson, MD, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680040
- Sponsor's protocol ID
- 2018-06
- Acronym
- RESILIENCE
- Status last verified
- May 2024
- First submitted
- 10 Sep 2018
- Last updated
- 9 May 2024
- 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 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Non-randomized Single Arm Multi-center Evaluation of the Durability of Aortic Bioprostheses/Valves With RESILIA Tissue in Subjects Under 65 (RESILIENCE Trial)
- ClinicalTrials.gov ID
- NCT03680040
- Acronym / sponsor ID
- RESILIENCE / 2018-06
- Conditions
- Aortic Valve Replacement
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 13 Feb 2024 (actual)
- Study completion
- 13 Feb 2024 (actual)
- First posted
- 21 Sep 2018 (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 objective of this observational trial is to determine time to valve failure due to valve deterioration requiring re-intervention and collect/investigate early potential predictors of valve durability (e.g., calcification and hemodynamic deterioration) in RESILIA tissue valves.
Detailed description
Multicenter, prospective, non-randomized, single-arm, observational trial. Subjects will be evaluated at 5, 7, 9, and 11 years post-implant. Up to two hundred fifty (250) total subjects at up to fifteen (15) investigational sites will be enrolled.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects previously implanted with a RESILIA aortic tissue valve.
Key inclusion criteria (4 listed)
- 18 years or older
- Subject currently has an Edwards pericardial aortic bioprosthesis with RESILIA tissue
- Provides voluntary written informed consent prior to the first trial related procedure
- Subject agrees to attend follow-up assessments as specified in the protocol
Key exclusion criteria (8 listed)
- Age 65 years or older at time of aortic valve replacement
- The Subject is pregnant or planning to become pregnant at the time of screening
- Re-intervention required on the bioprosthetic aortic valve prior to screening
- Active endocarditis or history of endocarditis on bioprosthetic aortic valve
- Estimated life expectancy <24 months
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 a RESILIA aortic tissue valve.Subjects to undergo multi-slice computed tomography and echocardiogram to assess predictors of valve durability in previously implanted Edwards aortic valves with RESILIA tissue. | Diagnostic test | – |
Primary outcome
Time to bioprosthetic valve failure due to valve deterioration
Time frame: 11 years post-implant
Time to bioprosthetic valve failure due to valve deterioration is defined as subject requiring valve re-intervention (redo surgery, valve-in-valve) or confirmed study valve-related death.
1 secondary outcome
Collection of early possible predictors of valve failure including leaflet calcification and morphological/hemodynamic valve deterioration
Time frame: 5, 7, 9, and 11 years post-implant
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- 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.
Joseph Bavaria, MD principal investigator
Organizational Affiliation: Hospital of the University of Pennsylvania
Lars Svensson, MD, PhD principal investigator
The Cleveland Clinic
10 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 10 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 4 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: stopped early, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
The study was stopped early (reason given: Low enrollment). 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?
Time to bioprosthetic valve failure due to valve deterioration (time frame: 11 years post-implant). 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 9 May 2024.