Aortic Valve DiseaseROSSNCT06352671
Prospective Long-Term Outcomes of a Standardized Ross Procedure
An observational study of Aortic Valve Disease, run by Baylor Research Institute at 1 site in United States.
Trial summary
This standardized prospective long-term outcome analysis will help reaffirm these findings via a multicenter patient cohort and describe the best practices/techniques for stabilization of the autograft and right ventricular outflow tract reconstruction. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Aortic Valve Disease
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2023to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients undergoing the Ross procedure at the four institutions of the NARC will be included in this study. The primary study center will be Baylor Scott and White The Heart Hospital. The other member institutions include: The University of Pennsylvania, The University of Washington, and Northwestern University. The investigators estimate to enroll around 20 subjects per year at each institution. This will total 80 subjects per year. The investigators plan to enroll patients for 10 years during the duration of the study. The investigators plan to follow patients for their lifetime.
Who may be able to join
- Patients undergoing Ross procedure at Baylor Scott and White The Heart Hospital, Plano, The University of Pennsylvania, The University of Washington, and Northwestern University.
Who cannot join
- Less than 18 years of age
- Presence of active malignancy
- Pregnant at the time of surgery
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Baylor Scott and White Heart Hospital
Plano, Texas, 75093
Bonnie Ostergren, 4698144181, Bonnie.Ostergren@BSWHealth.org
Sarah Hale, 4698144845, sarah.hale@bswhealth.org
About this study
This standardized prospective long-term outcome analysis will help reaffirm these findings via a multicenter patient cohort and describe the best practices/techniques for stabilization of the autograft and right ventricular outflow tract reconstruction.
Read the detailed description
The optimal approach for aortic valve replacement in adults with an anticipated life expectancy greater than fifteen years remains unclear. Mechanical and bioprosthetic valves, while often used, have specific downfalls. Mechanical valves require lifelong anticoagulation usage and bioprosthetic tissue valves have a limited lifespan. The Ross procedure (pulmonary autograft replacement) is the only operation which replaces the diseased aortic valve with a living substitute. Concerns over increased surgical risk and potential long-term failure have shown decreased use of this procedure. However, recent publications from expert centers have shown, in the current era the Ross procedure can be reliably performed safely and reproducibly in selected patients. This standardized prospective long-term outcome analysis will help reaffirm these findings via a multicenter patient cohort and describe the best practices/techniques for stabilization of the autograft and right ventricular outflow tract reconstruction.
- Conditions
- Aortic Valve Disease
- Medical subject headings
- Aortic Valve Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of the patient
The primary endpoint of this study will be survival at 1-, 5-, and 10-year intervals.
Measured: 1 year, 5 year and 10 year
Secondary outcomes (8)
Rate of re-hospitalization
To identify the safety of the Ross procedure measured in percentage
Measured: 1 year after the procedure
Rate of peri operative morbidity
Will be measured in percentage
Measured: 1 year after the procedure
Rate of re-operation
Will be measured in percentage
Measured: 1 year after the procedure
Rate of re-intervention
will be measured in percentage
Measured: 1 year after the procedure
NYHA status
Will be measured as NYHA class I, II,III, IV
Measured: 1 year after the procedure
Rate of Patients with Anticoagulant Usage
Rate of Patients with Anticoagulant Usage 1 year after procedure.
Measured: 1 year after the procedure
Rate of Bleeding Events
Rate of Bleeding Events
Measured: 1 year after the procedure
Rate of Post Operative Infection
Rate of Post Operative Infection
Measured: 1 year after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start12 Oct 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe 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
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352671
- Sponsor's protocol ID
- 023-286
- Acronym
- ROSS
- Status last verified
- Feb 2026
- First submitted
- 2 Apr 2024
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Catterall F, Ames PR, Isles C. Warfarin in patients with mechanical heart valves. BMJ. 2020 Oct 15;371:m3956. doi: 10.1136/bmj.m3956. No abstract available.
PubMed 33060144El-Hamamsy I, Toyoda N, Itagaki S, Stelzer P, Varghese R, Williams EE, Erogova N, Adams DH. Propensity-Matched Comparison of the Ross Procedure and Prosthetic Aortic Valve Replacement in Adults. J Am Coll Cardiol. 2022 Mar 1;79(8):805-815. doi: 10.1016/j.jacc.2021.11.057.
PubMed 35210036Mazine A, David TE, Rao V, Hickey EJ, Christie S, Manlhiot C, Ouzounian M. Long-Term Outcomes of the Ross Procedure Versus Mechanical Aortic Valve Replacement: Propensity-Matched Cohort Study. Circulation. 2016 Aug 23;134(8):576-85. doi: 10.1161/CIRCULATIONAHA.116.022800. Epub 2016 Aug 5.
PubMed 27496856Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A, Toly C. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021 Feb 2;143(5):e72-e227. doi: 10.1161/CIR.0000000000000923. Epub 2020 Dec 17. No abstract available.
PubMed 33332150
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Long-Term Outcomes of a Standardized Ross Procedure
- ClinicalTrials.gov ID
- NCT06352671
- Acronym / sponsor ID
- ROSS / 023-286
- Conditions
- Aortic Valve Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 8 Apr 2024 (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.
This standardized prospective long-term outcome analysis will help reaffirm these findings via a multicenter patient cohort and describe the best practices/techniques for stabilization of the autograft and right ventricular outflow tract reconstruction.
Detailed description
The optimal approach for aortic valve replacement in adults with an anticipated life expectancy greater than fifteen years remains unclear. Mechanical and bioprosthetic valves, while often used, have specific downfalls. Mechanical valves require lifelong anticoagulation usage and bioprosthetic tissue valves have a limited lifespan. The Ross procedure (pulmonary autograft replacement) is the only operation which replaces the diseased aortic valve with a living substitute. Concerns over increased surgical risk and potential long-term failure have shown decreased use of this procedure. However, recent publications from expert centers have shown, in the current era the Ross procedure can be reliably performed safely and reproducibly in selected patients. This standardized prospective long-term outcome analysis will help reaffirm these findings via a multicenter patient cohort and describe the best practices/techniques for stabilization of the autograft and right ventricular outflow tract reconstruction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients undergoing the Ross procedure at the four institutions of the NARC will be included in this study. The primary study center will be Baylor Scott and White The Heart Hospital. The other member institutions include: The University of Pennsylvania, The University of Washington, and Northwestern University. The investigators estimate to enroll around 20 subjects per year at each institution. This will total 80 subjects per year. The investigators plan to enroll patients for 10 years during the duration of the study. The investigators plan to follow patients for their lifetime.
Key inclusion criteria (1 listed)
- Patients undergoing Ross procedure at Baylor Scott and White The Heart Hospital, Plano, The University of Pennsylvania, The University of Washington, and Northwestern University.
Key exclusion criteria (4 listed)
- Less than 18 years of age
- Presence of active malignancy
- Pregnant at the time of surgery
- Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival of the patient
Time frame: 1 year, 5 year and 10 year
The primary endpoint of this study will be survival at 1-, 5-, and 10-year intervals.
8 secondary outcomes
Rate of re-hospitalization
Time frame: 1 year after the procedure
Rate of peri operative morbidity
Time frame: 1 year after the procedure
Rate of re-operation
Time frame: 1 year after the procedure
Rate of re-intervention
Time frame: 1 year after the procedure
NYHA status
Time frame: 1 year after the procedure
Rate of Patients with Anticoagulant Usage
Time frame: 1 year after the procedure
Rate of Bleeding Events
Time frame: 1 year after the procedure
Rate of Post Operative Infection
Time frame: 1 year after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Background: PubMed 33060144Catterall F, Ames PR, Isles C. Warfarin in patients with mechanical heart valves. BMJ. 2020 Oct 15;371:m3956. doi: 10.1136/bmj.m3956. No abstract available.
- Background: PubMed 35210036El-Hamamsy I, Toyoda N, Itagaki S, Stelzer P, Varghese R, Williams EE, Erogova N, Adams DH. Propensity-Matched Comparison of the Ross Procedure and Prosthetic Aortic Valve Replacement in Adults. J Am Coll Cardiol. 2022 Mar 1;79(8):805-815. doi: 10.1016/j.jacc.2021.11.057.
- Background: PubMed 27496856Mazine A, David TE, Rao V, Hickey EJ, Christie S, Manlhiot C, Ouzounian M. Long-Term Outcomes of the Ross Procedure Versus Mechanical Aortic Valve Replacement: Propensity-Matched Cohort Study. Circulation. 2016 Aug 23;134(8):576-85. doi: 10.1161/CIRCULATIONAHA.116.022800. Epub 2016 Aug 5.
- Background: PubMed 33332150Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A, Toly C. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021 Feb 2;143(5):e72-e227. doi: 10.1161/CIR.0000000000000923. Epub 2020 Dec 17. No abstract available.
Related trials for Aortic Valve Disease
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
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
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
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.
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 Aortic Valve Disease, run by Baylor Research Institute 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 4 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: looking for participants now, as of the sponsor's last update on 15 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bonnie Ostergren (4698144181, Bonnie.Ostergren@BSWHealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival of the patient (time frame: 1 year, 5 year and 10 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06352671, which also lists 4 linked publications.
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 15 Apr 2026.