German Aortic Valve Registry (GARY)
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Purpose
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.
- 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
| 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 |
- 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 ]
- 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:
|
Show Detailed Description Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with Aortic valve procedures from all German hospitals
Inclusion Criteria:
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).
Exclusion Criteria:
- No consent from the patient to collection and analysis of data.
Contacts and Locations| Contact: Elke Schaefer | 00492112807290 | e.schaefer@bqs-institut.de |
| Contact: Andreas Beckmann, Dr. | 004930 28004370 | gf@aortenklappenregister.de |
| 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 | |
| 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:
| 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 Insufficiency Aortic Valve Stenosis Constriction, Pathologic Heart Valve Diseases |
Heart Diseases Cardiovascular Diseases Ventricular Outflow Obstruction Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 19, 2013