German Aortic Valve Registry

NCT01165827 | Unknown DMC

• 1 other identifier: GERMANAVR-2010
• Study Type: observational
• Target: 100,000
• Locations: 1 country
• Sites: 1

Brief Summary

• V-TAVI, vascular transcatheter aortic valve implantation and
• A-TAVI, apical transcatheter aortic valve implantation. For some time, percutaneous balloon valvuloplasty has been used as a palliative measure for specific patients. New developments have triggered assumptions that there will over the coming years be a certain reorientation to the treatment of patients with aortic valve defects. In a positioning paper published jointly by the German Cardiac Society (DGK) and the German Society for Thoracic and Cardiovascular Surgery (DGTHG), there is a consensus that these new techniques can be used on patients who have either contraindications against conventional surgery or who are at high risk of preoperative mortality, e.g. due to severe comorbidities. As there is as yet only limited experience in this field and neither randomised trials nor long-term-results are available, the use of new implantation techniques is therefore not recommended for younger patients or patients without comorbidities. There is accordingly an urgent need for any introduction of this innovative medical procedure to be stringently monitored according to scientific principles. The goal of the planned Germany Aortic Valve Register is to evaluate the new treatments from the point of view of benefits und risks with respect to the gold standard of conventional surgery, with a view to compiling evidence-based indication criteria. The register will furthermore allow for the first time a comparison of various operative procedures, such as Ross procedure, David procedure and various mechanical or biological aortic valve implants.
• Rationale of the study design Randomised trials in controlled environments are considered best scientific practice for verifying the efficacy of a new method. The disadvantage is that only a small part of potential patients can be included in the trial, and results therefore reflect only a small section of the real world. Furthermore, a randomised study design is for ethical reasons not an acceptable approach to all questions, especially when contraindications exist for a certain branch of treatments and the spectrum of treatments is to be expanded. Nevertheless, new procedures have to be critically and scientifically analysed if the risk-benefit ratio is to be accurately determined. National heath authorities therefore request register data in addition to controlled trials in order to verify the safety and efficacy of new procedures across larger patient populations.
• Objectives
• Description of structure, process and outcome quality for the various techniques of aortic valve therapies
• Definition of indication criteria (e.g. through scoring systems)
• Collection of information on quality and safety for special medical devices
• Evaluation of quality of care on the level of participating centres with a view to increasing quality
• Health economic evaluation of the applied treatments
• Study design Prospective, controlled, multicenter register study

Conditions

Aortic Valve Insufficiency; Aortic Valve Stenosis

Keywords

Aortic Valve Insufficiency; Aortic Valve Stenosis; Aortic Valve Valvuloplasty; Aortic valve Replacement; Aortic valve Intervention

Outcome Measures

Primary Outcomes (4)

• All cause mortality

  1 year

• All cause mortality

  3 years

• All cause mortality

  5 years

• All cause mortality

  30 days

Secondary Outcomes (10)

• Non-fatal severe complications

  In-Hospital

• Quality of life following aortic valve procedure

  1 year

• Severity of clinical symptoms

  30 days

• Non-fatal severe complications

  30 days

• Non-fatal severe complications

  1 year

Study Arms (1)

Patients with aortic valve procedures

All consecutive patients from participating hospitals with aortic valve defects who have received one of the following therapies: 1. surgical aortic valve replacement, 2. percutaneous transvascular (retrograde) aortic valve implantation 3. percutaneous transapical aortic valve implantation as principal indication. If the aortic valve insufficiency is concurrent with combination procedures (e.g. coronary artery bypass graft, mitral valve surgery) the aortic valve stenosis must fulfil only the criteria for indication according to the German National guidelines (see: detailed study description).

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

Patients with Aortic valve procedures from all German hospitals

You may qualify if:

• All consecutive patients from participating hospitals with aortic valve defects who have received one of the following therapies:
• surgical aortic valve replacement,
• aortic valve surgery (Ross procedure, David procedure)
• percutaneous transvascular (retrograde) aortic valve implantation
• percutaneous transapical aortic valve implantation
• aortic valve valvuloplasty as principal indication. If the aortic valve insufficiency is concurrent with combination procedures (e.g. coronary artery bypass graft, mitral valve surgery) the aortic valve stenosis must fulfil only the criteria for indication according to the German guidelines (Hamm et al. 2008).

You may not qualify if:

• No consent from the patient to collection and analysis of data.

Sponsors & Collaborators

• German Aortic Valve Registry: lead
• German Society for Thoracic and Cardiovascular Surgery: collaborator
• German Cardiac Society: collaborator
• BQS Institute for Quality and Patient Safety: collaborator
• Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK): collaborator

Study Sites (1)

BQS Institute for Quality and Patient Safety

Düsseldorf, North Rhine-Westphalia, 40472, Germany

RECRUITING

Related Publications (11)

• Lindroos M, Kupari M, Heikkila J, Tilvis R. Prevalence of aortic valve abnormalities in the elderly: an echocardiographic study of a random population sample. J Am Coll Cardiol. 1993 Apr;21(5):1220-5. doi: 10.1016/0735-1097(93)90249-z.

  PMID: 8459080 BACKGROUND

• Gummert JF, Funkat A, Beckmann A, Schiller W, Hekmat K, Ernst M, Haverich A. Cardiac surgery in Germany during 2008. A report on behalf of the German Society for Thoracic and Cardiovascular Surgery. Thorac Cardiovasc Surg. 2009 Sep;57(6):315-23. doi: 10.1055/s-0029-1185915. Epub 2009 Aug 25.

  PMID: 19707971 BACKGROUND

• Walther T, Falk V, Kempfert J, Borger MA, Fassl J, Chu MW, Schuler G, Mohr FW. Transapical minimally invasive aortic valve implantation; the initial 50 patients. Eur J Cardiothorac Surg. 2008 Jun;33(6):983-8. doi: 10.1016/j.ejcts.2008.01.046. Epub 2008 Feb 21.

  PMID: 18294859 BACKGROUND

• Walther T, Falk V, Dewey T, Kempfert J, Emrich F, Pfannmuller B, Broske P, Borger MA, Schuler G, Mack M, Mohr FW. Valve-in-a-valve concept for transcatheter minimally invasive repeat xenograft implantation. J Am Coll Cardiol. 2007 Jul 3;50(1):56-60. doi: 10.1016/j.jacc.2007.03.030. Epub 2007 Jun 18.

  PMID: 17601546 BACKGROUND

• Sack S, Kahlert P, Khandanpour S, Naber C, Philipp S, Mohlenkamp S, Sievers B, Kalsch H, Erbel R. Revival of an old method with new techniques: balloon aortic valvuloplasty of the calcified aortic stenosis in the elderly. Clin Res Cardiol. 2008 May;97(5):288-97. doi: 10.1007/s00392-008-0650-0. Epub 2008 Apr 3.

  PMID: 18389165 BACKGROUND

• Hamm CW, Albrecht A, Bonzel T, Kelm M, Lange H, Schachinger V, Terres W, Voelker W. [Diagnostic heart catheterization]. Clin Res Cardiol. 2008 Aug;97(8):475-512. doi: 10.1007/s00392-008-0686-1. No abstract available. German.

  PMID: 18726641 BACKGROUND

• Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, Derumeaux G, Anselme F, Laborde F, Leon MB. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002 Dec 10;106(24):3006-8. doi: 10.1161/01.cir.0000047200.36165.b8.

  PMID: 12473543 BACKGROUND

• Webb JG, Pasupati S, Humphries K, Thompson C, Altwegg L, Moss R, Sinhal A, Carere RG, Munt B, Ricci D, Ye J, Cheung A, Lichtenstein SV. Percutaneous transarterial aortic valve replacement in selected high-risk patients with aortic stenosis. Circulation. 2007 Aug 14;116(7):755-63. doi: 10.1161/CIRCULATIONAHA.107.698258. Epub 2007 Jul 23.

  PMID: 17646579 BACKGROUND

• Himbert D, Al Attar N, Depoix J-P, Nataf P, Vahanian A. Prise en charge de la stenose aortique du sujet age: un travail d'equipe Cardiologie Pratique. 2008;831:1-8

  BACKGROUND

• Figulla HR J Cremer, T Walther, et al. Positionspapier zur kathetergeführten Aortenklappenintervention Kardiologe 2009;3:199-206

  BACKGROUND

• Ensminger S, Fujita B, Bauer T, Mollmann H, Beckmann A, Bekeredjian R, Bleiziffer S, Landwehr S, Hamm CW, Mohr FW, Katus HA, Harringer W, Walther T, Frerker C; GARY Executive Board. Rapid Deployment Versus Conventional Bioprosthetic Valve Replacement for Aortic Stenosis. J Am Coll Cardiol. 2018 Apr 3;71(13):1417-1428. doi: 10.1016/j.jacc.2018.01.065.

  PMID: 29598861 DERIVED

Related Links

• Homepage of the German Aortic Valve Registry

MeSH Terms

Conditions

Aortic Valve Insufficiency; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Friedhelm Beyersdorf, Prof. Dr.

  German Society for Thoracic and Cardiovascular Surgery

  STUDY CHAIR

• Christian Hamm, Prof. Dr.

  German Cardiac Society

  STUDY CHAIR

Central Study Contacts

Anna Niemeyer, Dr.

CONTACT

+49 40 254 078 56; anna.niemeyer@bqs.de

Andreas Beckmann, Dr.

CONTACT

004930 28004370; gf@aortenklappenregister.de

Study Design

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

Study Record Dates

• First Submitted: July 16, 2010
• First Posted: July 20, 2010
• Study Start: July 1, 2010
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 15, 2021

Record last verified: 2021-02

Locations

DE (1)