NCT06352671

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Oct 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Oct 2023Dec 2026

Study Start

First participant enrolled

October 12, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 8, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 15, 2026

Status Verified

February 1, 2026

Enrollment Period

3.1 years

First QC Date

April 2, 2024

Last Update Submit

April 13, 2026

Conditions

Aortic Valve Disease

Outcome Measures

Primary Outcomes (1)

  • Survival of the patient

    The primary endpoint of this study will be survival at 1-, 5-, and 10-year intervals.

    1 year, 5 year and 10 year

Secondary Outcomes (8)

  • Rate of re-hospitalization

    1 year after the procedure

  • Rate of peri operative morbidity

    1 year after the procedure

  • Rate of re-operation

    1 year after the procedure

  • Rate of re-intervention

    1 year after the procedure

  • NYHA status

    1 year after the procedure

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Patients undergoing Ross procedure at Baylor Scott and White The Heart Hospital, Plano, The University of Pennsylvania, The University of Washington, and Northwestern University.

You may not qualify if:

  • Less than 18 years of age
  • Presence of active malignancy
  • Pregnant at the time of surgery
  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor Scott and White Heart Hospital

Plano, Texas, 75093, United States

RECRUITING

Related Publications (4)

  • 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.

    PMID: 33060144BACKGROUND

  • El-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.

    PMID: 35210036BACKGROUND

  • Mazine 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.

    PMID: 27496856BACKGROUND

  • Otto 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.

    PMID: 33332150BACKGROUND

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Central Study Contacts

Bonnie Ostergren

CONTACT

4698144181Bonnie.Ostergren@BSWHealth.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2024

First Posted

April 8, 2024

Study Start

October 12, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 15, 2026

Record last verified: 2026-02

Locations

US(1)