Aortic Valve DiseaseNCT00708409
Long-Term Follow-up After the Autograft Aortic Valve Procedure (Ross Operation)
An observational study of Aortic Valve Disease, run by University of Luebeck at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Disease
- What is being tested?
- Cardiac valve surgery
- Type of treatment
- Surgery or procedure
- How many people
- 1,800 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2001to Dec 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: primary care clinic
Who may be able to join
- 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,
Who cannot join
- Extensive coronary artery disease, extensive aortic root calcification, severely impaired left ventricular function, failure to provide informed consent, current participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Clinic of Schleswig Holstein, Campus Luebeck
Lübeck, 23538
About this study
Official title: Long-Term Follow-up After the Autograft Aortic Valve Procedure (Ross Operation)-the German-Dutch- Ross Registry
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
Read the detailed description
For patients with aortic valve disease requiring surgical treatment several options are available. In some instances the valve can be repaired, however replacement of the valve is usually necessary. The choice for a particular aortic valve replacement procedure is influenced by several inter-related factors (e.g. prosthesis, procedure itself, patient age, concomitant disease, atrial fibrillation, center's experience, and preference of the referring cardiologist, the attending surgeon and the patient). Often, more than one type of prosthesis seems suitable for the individual patient, whereby the decision for a particular prosthesis is made rather arbitrarily.
With the current knowledge on outcome of patients after aortic valve replacement with different types of prosthesis (pulmonary autograft according to Ross, bioprosthesis, mechanical heart valve), no specific recommendation can be given. This is especially true for the autograft, since no long-term outcome is yet available from clinical practice.
In 2001 the German Ross Registry was established by our working group. Although the Ross procedure was expected to be a lifelong solution for aortic valve disease, it seemed appropriate to make a collaborative effort to establish a multicenter long term follow-up study to examine longitudinal clinical outcomes associated with the procedure, as well as, attempt to resolve and identify the many technical considerations necessary for successful execution of the procedure. With these issues in mind, we have already included about 1400 Ross operated patients from nine participating centers into the registry with up to fourteen years follow-up. The first release of an annual report was presented in February 2004. The main limitation of this Registry is the limited maximal time span of follow-up keeping in mind that the next years of the follow-up are most important for evaluating the Ross procedure because possible degeneration of the aortic valve substitute may occur.
Therefore long-term observation is required.
- Conditions
- Aortic Valve Disease
- Being tested
- Cardiac valve surgery
- Keywords
- Ross operation, autograft procedure, pulmonary homograft, root replacement technique, subcoronary implantation technique
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac valve surgeryProcedure or surgery
Also called Ross operation, autograft, homograft
Different autograft implantation techniques.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Autograft operations with the subcoronary technique Receives: Procedure: Cardiac valve surgery | |
| 2 | Autograft operations with the root replacement technique Receives: Procedure: Cardiac valve surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause reoperation rate
Measured: one year
Secondary outcomes (1)
valve-related mortality
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2008 (estimated)
- Study startJan 2001
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Investigators
- Hans-Hinrich Sievers, MD, Principal investigator, University Schleswig-Holstein, Campus Lübeck, Clinic for cardiac surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00708409
- Sponsor's protocol ID
- Ross-01
- Status last verified
- Jan 2009
- First submitted
- 27 Jun 2008
- Last updated
- 16 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33736823Charitos 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.
PubMed 22883549Charitos 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.
PubMed 22197618Sievers 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.
PubMed 20837916Sievers 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.
PubMed 20299029
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Follow-up After the Autograft Aortic Valve Procedure (Ross Operation)-the German-Dutch- Ross Registry
- ClinicalTrials.gov ID
- NCT00708409
- Acronym / sponsor ID
- Ross-01
- Conditions
- Aortic Valve Disease
- Keywords
- Ross operation, autograft procedure, pulmonary homograft, root replacement technique, subcoronary implantation technique
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- Jan 2001
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 2 Jul 2008 (estimated)
- 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.
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
Detailed description
For patients with aortic valve disease requiring surgical treatment several options are available. In some instances the valve can be repaired, however replacement of the valve is usually necessary. The choice for a particular aortic valve replacement procedure is influenced by several inter-related factors (e.g. prosthesis, procedure itself, patient age, concomitant disease, atrial fibrillation, center's experience, and preference of the referring cardiologist, the attending surgeon and the patient). Often, more than one type of prosthesis seems suitable for the individual patient, whereby the decision for a particular prosthesis is made rather arbitrarily.
With the current knowledge on outcome of patients after aortic valve replacement with different types of prosthesis (pulmonary autograft according to Ross, bioprosthesis, mechanical heart valve), no specific recommendation can be given. This is especially true for the autograft, since no long-term outcome is yet available from clinical practice.
In 2001 the German Ross Registry was established by our working group. Although the Ross procedure was expected to be a lifelong solution for aortic valve disease, it seemed appropriate to make a collaborative effort to establish a multicenter long term follow-up study to examine longitudinal clinical outcomes associated with the procedure, as well as, attempt to resolve and identify the many technical considerations necessary for successful execution of the procedure. With these issues in mind, we have already included about 1400 Ross operated patients from nine participating centers into the registry with up to fourteen years follow-up. The first release of an annual report was presented in February 2004. The main limitation of this Registry is the limited maximal time span of follow-up keeping in mind that the next years of the follow-up are most important for evaluating the Ross procedure because possible degeneration of the aortic valve substitute may occur.
Therefore long-term observation is required.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Cardiac valve surgeryAutograft operations with the subcoronary technique |
| 2 | – | Procedure: Cardiac valve surgeryAutograft operations with the root replacement technique |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (1 listed)
- 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,
Key exclusion criteria (1 listed)
- Extensive coronary artery disease, extensive aortic root calcification, severely impaired left ventricular function, failure to provide informed consent, current participation in another clinical trial
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 |
|---|---|---|
| Cardiac valve surgeryAlso: Ross operation, autograft, homograftDifferent autograft implantation techniques. | Procedure or surgery | 1, 2 |
Primary outcome
all cause reoperation rate
Time frame: one year
1 secondary outcome
valve-related mortality
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2009.
- Derived from this study: PubMed 33736823Aboud 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.
- Derived from this study: PubMed 22883549Charitos 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.
- Derived from this study: PubMed 22197618Charitos 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.
- Derived from this study: PubMed 20837916Sievers 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.
- Derived from this study: PubMed 20299029Sievers 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.
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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.
Hans-Hinrich Sievers, MD principal investigator
University Schleswig-Holstein, Campus Lübeck, Clinic for cardiac surgery
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 University of Luebeck at 1 site in Germany.
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 16 Feb 2009. 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 Germany. 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?
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?
all cause reoperation rate (time frame: one 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 NCT00708409, which also lists 5 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 16 Feb 2009.