Long-Term Follow-up After the Autograft Aortic Valve Procedure (Ross Operation)

NCT00708409 | Unknown

• 1 other identifier: Ross-01
• Study Type: observational
• Target: 1,800
• Locations: 1 country
• Sites: 1

Brief Summary

With the current knowledge of aortic valve replacement modalities, no specific recommendations can be given and the decision for a particular prosthesis or procedure is rather arbitrarily. The investigators hypothesize that the autograft procedure according to Ross is superior in terms of hemodynamic (especially regression of left ventricular hypertrophy) and major adverse valve related events even in a long-term course

Conditions

Aortic Valve Disease

Keywords

Ross operation; autograft procedure; pulmonary homograft; root replacement technique; subcoronary implantation technique

Outcome Measures

Primary Outcomes (1)

• all cause reoperation rate

  one year

Secondary Outcomes (1)

• valve-related mortality

  one year

Study Arms (2)

1

Autograft operations with the subcoronary technique

Procedure: Cardiac valve surgery

2

Autograft operations with the root replacement technique

Procedure: Cardiac valve surgery

Interventions

Cardiac valve surgery PROCEDURE

Different autograft implantation techniques.

Also known as: Ross operation, autograft, homograft

1; 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

You may qualify if:

• Patients with the need for aortic valve replacement, aortic valve replacement in the young with the need of valve growth potential, contraindication to oral anticoagulation therapy, female patients with the wish of childbearing,

You may not qualify if:

• Extensive coronary artery disease, extensive aortic root calcification, severely impaired left ventricular function, failure to provide informed consent, current participation in another clinical trial

Sponsors & Collaborators

• University of Luebeck: lead

Study Sites (1)

University Clinic of Schleswig Holstein, Campus Luebeck

Lübeck, 23538, Germany

Location

Related Publications (5)

• Aboud A, Charitos EI, Fujita B, Stierle U, Reil JC, Voth V, Liebrich M, Andreas M, Holubec T, Bening C, Albert M, Fila P, Ondrasek J, Murin P, Lange R, Reichenspurner H, Franke U, Gorski A, Moritz A, Laufer G, Hemmer W, Sievers HH, Ensminger S. Long-Term Outcomes of Patients Undergoing the Ross Procedure. J Am Coll Cardiol. 2021 Mar 23;77(11):1412-1422. doi: 10.1016/j.jacc.2021.01.034.

  PMID: 33736823 DERIVED

• Charitos EI, Takkenberg JJ, Hanke T, Gorski A, Botha C, Franke U, Dodge-Khatami A, Hoerer J, Lange R, Moritz A, Ferrari-Kuehne K, Hetzer R, Huebler M, Bogers AJ, Stierle U, Sievers HH, Hemmer W. Reoperations on the pulmonary autograft and pulmonary homograft after the Ross procedure: An update on the German Dutch Ross Registry. J Thorac Cardiovasc Surg. 2012 Oct;144(4):813-21; discussion 821-3. doi: 10.1016/j.jtcvs.2012.07.005. Epub 2012 Aug 9.

  PMID: 22883549 DERIVED

• Charitos EI, Stierle U, Hanke T, Schmidtke C, Sievers HH, Richardt D. Long-term results of 203 young and middle-aged patients with more than 10 years of follow-up after the original subcoronary Ross operation. Ann Thorac Surg. 2012 Feb;93(2):495-502. doi: 10.1016/j.athoracsur.2011.10.017. Epub 2011 Dec 22.

  PMID: 22197618 DERIVED

• Sievers HH, Stierle U, Charitos EI, Hanke T, Misfeld M, Matthias Bechtel JF, Gorski A, Franke UF, Graf B, Robinson DR, Bogers AJ, Dodge-Khatami A, Boehm JO, Rein JG, Botha CA, Lange R, Hoerer J, Moritz A, Wahlers T, Breuer M, Ferrari-Kuehne K, Hetzer R, Huebler M, Ziemer G, Takkenberg JJ, Hemmer W; German-Dutch Ross Registry. Major adverse cardiac and cerebrovascular events after the Ross procedure: a report from the German-Dutch Ross Registry. Circulation. 2010 Sep 14;122(11 Suppl):S216-23. doi: 10.1161/CIRCULATIONAHA.109.925800.

  PMID: 20837916 DERIVED

• Sievers HH, Stierle U, Charitos EI, Hanke T, Gorski A, Misfeld M, Bechtel M. Fourteen years' experience with 501 subcoronary Ross procedures: surgical details and results. J Thorac Cardiovasc Surg. 2010 Oct;140(4):816-22, 822.e1-5. doi: 10.1016/j.jtcvs.2009.11.042. Epub 2010 Mar 17.

  PMID: 20299029 DERIVED

MeSH Terms

Conditions

Aortic Valve Disease

Interventions

Transplantation, Autologous; Transplantation, Homologous

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Officials

• Hans-Hinrich Sievers, MD

  University Schleswig-Holstein, Campus Lübeck, Clinic for cardiac surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 27, 2008
• First Posted: July 2, 2008
• Study Start: January 1, 2001
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 16, 2009

Record last verified: 2009-01

Locations

DE (1)