Heart Valve ProsthesisNCT05986396
Outcomes of Pulmonary Valve Replacement With the INSPIRIS (Model 11500A) Valve
An observational study of Heart Valve Prosthesis, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The goal of this retrospective chart review is to contribute to the literature on the mid-term durability and hemodynamics of the INSPIRS Resilia bioprosthesis when implanted in children and young adults. Read more about this study
- Who is it for?
- Ages 0 to 64 years
- Conditions the study is for
- Heart Valve Prosthesis
- What is being tested?
- INSPIRIS Resilia (model 11500A)
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2023to 31 Dec 2025
- 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 0 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Subjects with congenital heart disease that have received the INSPIRIS Resilia device.
Who may be able to join
- Subjects that have received the INSPIRIS Resilia device at participating institutions from 06/2017 through 12/2022.
Who cannot join
- Subjects that have not received the INSPIRIS Resilia device.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Baylor College of Medicine at CHRISTUS Children's
San Antonio, Texas, 78207
Rosario Ocampo, BSN, 210-704-4996, rosario.ocampo@christushealth.org
About this study
Official title: Outcomes of Pulmonary Valve Replacement With the INSPIRIS (Model 11500A) Valve for Pulmonary Valve Replacement in Children and Young Adults
The goal of this retrospective chart review is to contribute to the literature on the mid-term durability and hemodynamics of the INSPIRS Resilia bioprosthesis when implanted in children and young adults.
Read the detailed description
The primary objective of our study is to contribute to the scarce body of literature on the mid-term durability and hemodynamics of the INSPIRIS Resilia (model 11500) bioprosthesis when implanted in the pulmonary position in children and young adults. Investigators also aim to identify: effect of age on SVD, freedom from SVD, pathology of SVD, valve-related complications, freedom from re-operation, and survival rate.
- Conditions
- Heart Valve Prosthesis
- Being tested
- INSPIRIS Resilia (model 11500A)
- Keywords
- Pulmonary Valve Replacement, Pulmonary Valve, Congenital Heart Disease, INSPIRIS Resilia
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INSPIRIS Resilia (model 11500A)Device
Aortic Valve
| Study group | Role | What they receive |
|---|---|---|
| All Subjects | Subjects that have received the INSPIRIS Resilia device. Receives: Device: INSPIRIS Resilia (model 11500A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contribute to the scarce body of literature
The primary objective of our study is to contribute to the scarce body of literature on the mid-term durability and hemodynamics of the INSPIRIS Resilia (model 11500) bioprosthesis when implanted in the pulmonary position in children and young adults
Measured: 5 years after implantation
Secondary outcomes (1)
Identify the effect of age of the INSPIRIS Resilia (model 11500) bioprosthesis when implanted in the pulmonary position in children and young adults
Structural valve deterioration, freedom from SVD, valve related complications, freedom from re-operation, survival rate
Measured: 5 years after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start3 Jan 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Valve ProsthesisStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Responsible party
- Principal investigator, Victor Bautista Hernandez, Baylor College of Medicine
- Investigators
- Victor Bautista-Hernandez, MD, PhD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05986396
- Sponsor's protocol ID
- H-51357
- Status last verified
- Aug 2023
- First submitted
- 12 Jul 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Pulmonary Valve Replacement With the INSPIRIS (Model 11500A) Valve for Pulmonary Valve Replacement in Children and Young Adults
- ClinicalTrials.gov ID
- NCT05986396
- Acronym / sponsor ID
- H-51357
- Conditions
- Heart Valve Prosthesis
- Keywords
- Pulmonary Valve Replacement, Pulmonary Valve, Congenital Heart Disease, INSPIRIS Resilia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Edwards Lifesciences
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Aug 2023 (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 goal of this retrospective chart review is to contribute to the literature on the mid-term durability and hemodynamics of the INSPIRS Resilia bioprosthesis when implanted in children and young adults.
Detailed description
The primary objective of our study is to contribute to the scarce body of literature on the mid-term durability and hemodynamics of the INSPIRIS Resilia (model 11500) bioprosthesis when implanted in the pulmonary position in children and young adults. Investigators also aim to identify: effect of age on SVD, freedom from SVD, pathology of SVD, valve-related complications, freedom from re-operation, and survival rate.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Subjects | – | Device: INSPIRIS Resilia (model 11500A)Subjects that have received the INSPIRIS Resilia device. |
Who may qualify
- Ages
- 0 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Subjects with congenital heart disease that have received the INSPIRIS Resilia device.
Key inclusion criteria (1 listed)
- Subjects that have received the INSPIRIS Resilia device at participating institutions from 06/2017 through 12/2022.
Key exclusion criteria (1 listed)
- Subjects that have not received the INSPIRIS Resilia device.
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 |
|---|---|---|
| INSPIRIS Resilia (model 11500A)Aortic Valve | Device | All Subjects |
Primary outcome
Contribute to the scarce body of literature
Time frame: 5 years after implantation
The primary objective of our study is to contribute to the scarce body of literature on the mid-term durability and hemodynamics of the INSPIRIS Resilia (model 11500) bioprosthesis when implanted in the pulmonary position in children and young adults
1 secondary outcome
Identify the effect of age of the INSPIRIS Resilia (model 11500) bioprosthesis when implanted in the pulmonary position in children and young adults
Time frame: 5 years after implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Heart Valve Prosthesis
Active, not recruiting
Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses. The 'LYTEN' Trial
Aortic Valve Stenosis, Regurgitation, Aortic
Not yet recruitingObservational study
REVIVE-FR Registry
Bioprosthetic Valve Failure, Prosthetic Heart Valve Dysfunction
RecruitingObservational study
The ReTAVI Prospective Observational Registry
Structural Valve Deterioration, Structural Valve Degeneration
Not yet recruiting
Balloon- Versus Self-Expanding Intraannular TAVI in Small Aortic Annuli
Aortic Valve Stenosis
Active, not recruitingObservational study
Transcatheter Aortic Valve Implantation Versus Standard Surgical Aortic Valve Replacement
Prosthesis Survival, Prosthesis; Cardiac, Heart, Functional Disturbance as Result
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.
Victor Bautista-Hernandez, MD, PhD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Valve Prosthesis, run by Baylor College of Medicine at 1 site 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Rosario Ocampo, BSN (210-704-4996, rosario.ocampo@christushealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contribute to the scarce body of literature (time frame: 5 years after implantation). 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 14 Aug 2023.