Clinical Trial: German Aortic Valve Registry
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: National Prospective German Registry for Aortic Valve Therapy
Brief Summary:
-
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
Detailed Summary:
- Research aims
The increasing prevalence of severe aortic valve defects is a corollary to increases in life expectancy (Lindroos et al. 1993). 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 (Gummert et al. 2009). Several alternatives to established procedures have recently emerged:
- V-TAVI, vascular transcatheter aortic valve implantation and
- A-TAVI, apical transcatheter aortic valve implantation (Cribier et al. 2002, Walther et al. 2008, Webb et al. 2007, Himbert et al. 2008, Walther et al. 2007).
For some time, percutaneous balloon valvuloplasty (Sack et al. 2008) 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 (Figulla et al. 2009).
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
Sponsor: German Aortic Valve Registry
Current Primary Outcome:
- All cause mortality [ Time Frame: 1 year ]
- All cause mortality [ Time Frame: 3 years ]
- All cause mortality [ Time Frame: 5 years ]
- All cause mortality [ Time Frame: 30 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Non-fatal severe complications [ Time Frame: In-Hospital ]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 ]Assessment preoperatively by personal interview Postoperative by telephone interview Assessment instrument: EuroQoL 5-D-Questionnaire
- Severity of clinical symptoms [ Time Frame: 30 days ]Assessment of severity of heart failure using NYHA-Classification
- Non-fatal severe complications [ Time Frame: 30 days ]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 ]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 ]Assessment preoperatively by personal interview Postoperative by telephone interview Assessment instrument: EuroQoL 5-D-Questionnaire
- Quality of life [ Time Frame: 5 years ]Assessment preoperatively by personal interview Postoperative by telephone interview Assessment instrument: EuroQoL 5-D-Questionnaire
- Severity of clinical symptoms [ Time Frame: 1 year ]Assessment of severity of heart failure using NYHA-Classification
- Severity of clinical symptoms [ Time Frame: 3 years ]Assessment of severity of heart failure using NYHA-Classification
- Severity of clinical symptoms [ Time Frame: 5 years ]Assessment of severity of heart failure using NYHA-Classification
Original Secondary Outcome: Same as current
Information By: German Aortic Valve Registry
Dates:
Date Received: July 16, 2010
Date Started: July 2010
Date Completion: December 2017
Last Updated: February 11, 2016
Last Verified: February 2016
