German Aortic Valve Registry (GARY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2011 by German Aortic Valve Registry
Sponsor:
Collaborators:
Germany: German Society for Thoracic and Cardiovascular Surgery
Germany: German Cardiac Society
Germany: BQS Institute for Quality and Patient Safety
Information provided by (Responsible Party):
German Aortic Valve Registry
ClinicalTrials.gov Identifier:
NCT01165827
First received: July 16, 2010
Last updated: September 13, 2011
Last verified: September 2011
  Purpose
  1. Research aims

    The increasing prevalence of severe aortic valve defects is a corollary to increases in life expectancy. For many years, surgical valve replacement with extracorporeal circulation has been the gold standard in the treatment of severe aortic valve diseases. Every year, about 12,000 patients in Germany receive isolated aortic valve surgery. Several alternatives to established procedures have recently emerged:

    • 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.

  2. 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.
  3. Objectives

    1. Description of structure, process and outcome quality for the various techniques of aortic valve therapies
    2. Definition of indication criteria (e.g. through scoring systems)
    3. Collection of information on quality and safety for special medical devices
    4. Evaluation of quality of care on the level of participating centres with a view to increasing quality
    5. Health economic evaluation of the applied treatments
  4. Study design Prospective, controlled, multicenter register study

Condition
Aortic Valve Insufficiency
Aortic Valve Stenosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: National Prospective German Registry for Aortic Valve Therapy

Resource links provided by NLM:


Further study details as provided by German Aortic Valve Registry:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • All cause mortality [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • All cause mortality [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • All cause mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Non-fatal severe complications [ Time Frame: In-Hospital ] [ Designated as safety issue: Yes ]
    aortic valve re-intervention, coronary bypass surgery, myocardial infarction, stroke, other thromboembolic events, severe bleedings (requires transfusion) PCI, ICD, PM, dialysis, dehiscence of stitching

  • Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Assessment preoperatively by personal interview Postoperative by telephone interview Assessment instrument: EuroQoL 5-D-Questionnaire

  • Severity of clinical symptoms [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Assessment of severity of heart failure using NYHA-Classification

  • Non-fatal severe complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    aortic valve re-intervention, coronary bypass surgery, myocardial infarction, stroke, other thromboembolic events, severe bleedings (requires transfusion) PCI, ICD, PM, dialysis, dehiscence of stitching

  • Non-fatal severe complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    aortic valve re-intervention, coronary bypass surgery, myocardial infarction, stroke, other thromboembolic events, severe bleedings (requires transfusion) PCI, ICD, PM, dialysis, dehiscence of stitching

  • Quality of life [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Assessment preoperatively by personal interview Postoperative by telephone interview Assessment instrument: EuroQoL 5-D-Questionnaire

  • Quality of life [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Assessment preoperatively by personal interview Postoperative by telephone interview Assessment instrument: EuroQoL 5-D-Questionnaire

  • Severity of clinical symptoms [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Assessment of severity of heart failure using NYHA-Classification

  • Severity of clinical symptoms [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Assessment of severity of heart failure using NYHA-Classification

  • Severity of clinical symptoms [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Assessment of severity of heart failure using NYHA-Classification


Estimated Enrollment: 100000
Study Start Date: July 2010
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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. aortic valve surgery (Ross procedure, David procedure)
  3. percutaneous transvascular (retrograde) aortic valve implantation
  4. percutaneous transapical aortic valve implantation
  5. 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 National guidelines (see: detailed study description).

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Aortic valve procedures from all German hospitals

Criteria

Inclusion Criteria:

All consecutive patients from participating hospitals with aortic valve defects who have received one of the following therapies:

  1. surgical aortic valve replacement,
  2. aortic valve surgery (Ross procedure, David procedure)
  3. percutaneous transvascular (retrograde) aortic valve implantation
  4. percutaneous transapical aortic valve implantation
  5. 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).

Exclusion Criteria:

  • No consent from the patient to collection and analysis of data.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01165827

Contacts
Contact: Elke Schaefer 00492112807290 e.schaefer@bqs-institut.de
Contact: Andreas Beckmann, Dr. 004930 28004370 gf@aortenklappenregister.de

Locations
Germany
BQS Institute for Quality and Patient Safety Recruiting
Duesseldorf, NRW, Germany, 40472
Contact: Elke Schaefer    00492112807290    e.schaefer@bqs-institut.de   
Principal Investigator: Elke Schaefer         
Sponsors and Collaborators
German Aortic Valve Registry
Germany: German Society for Thoracic and Cardiovascular Surgery
Germany: German Cardiac Society
Germany: BQS Institute for Quality and Patient Safety
Investigators
Study Chair: Friedrich W Mohr, Prof. Dr. German Society for Thoracic and Cardiovascular Surgery
Study Chair: Christian Hamm, Prof. Dr. German Cardiac Society
  More Information

Additional Information:
Publications:
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

Responsible Party: German Aortic Valve Registry
ClinicalTrials.gov Identifier: NCT01165827     History of Changes
Other Study ID Numbers: GERMANAVR-2010
Study First Received: July 16, 2010
Last Updated: September 13, 2011
Health Authority: Germany: Ethics Committee
Germany: German Society for Thoracic and Cardiovascular Surgery
Germany: German Cardiac Society

Keywords provided by German Aortic Valve Registry:
Aortic Valve Insufficiency
Aortic Valve Stenosis
Aortic Valve Valvuloplasty
Aortic valve Replacement
Aortic valve Intervention

Additional relevant MeSH terms:
Aortic Valve Stenosis
Aortic Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on September 18, 2014