Aortic Stenosis Clinical Trial
— SIMPLIFy TAVIOfficial title:
Use of the Self-Expanding Medtronic CoreValve Prosthesis Without Predilation in Patients With Severely IMPaired Left-VentrIcular Ejection Fraction for TAVI Trial - The SIMPLIFy TAVI Trial
Verified date | November 2022 |
Source | University Hospital, Bonn |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to demonstrate that the avoidance of balloon valvuloplasty for predilation of the native aortic valve is associated with a reduction of the composite primary endpoint in TAVI patients with severely impaired left-ventricular ejection fraction (LVEF ≤35%).
Status | Completed |
Enrollment | 110 |
Est. completion date | November 22, 2019 |
Est. primary completion date | November 22, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - LVEF =35% - Aortic valve stenosis with an aortic valve area <1 cm2 (<0,6 cm3/m2) - Males or females at least 18 years of age - Logistic EuroSCORE =15% and age =75 years or if age <75 years: logistic EuroSCORE =20% and/or a significant contraindication for open heart surgery (e.g., porcelain aorta or severe COPD) - Signed informed consent Exclusion Criteria: - Patients with a device regulating the heart rhythm by pacing (e.g. pacemaker, resynchronization device, implanted defibrillator) - Patients with a pre-existing class I or class II indication for new pacemaker implantation according to the 2007 ESC guidelines - Lack of written informed consent, severe mental disorder, drug/alcohol addiction - Life expectancy < 1 year - Hypersensitivity or contraindication to acetyl salicyl acid, heparin, ticlopidine, clopidogrel, nitinol or sensitivity to contrast media that cannot be adequately premedicated - Recent myocardial infarction (STEMI within the last 3 months) - Left ventricular or atrial thrombus by echocardiography - Uncontrolled atrial fibrillation - Mitral or tricuspidal valvular insufficiency (> grade II) - Previous aortic valve replacement with mechanical valve - Evolutive or recent cerebrovascular event (within the last 3 months) - Vascular conditions that make insertion and endovascular access to the aortic valve impossible - Symptomatic carotid or vertebral arterial narrowing (>70%) disease - Abdominal or thoracic aortic aneurysm in the path of the delivery system - Bleeding diathesis or coagulopathy or patient refusing blood transfusion - Active gastritis or peptic ulcer disease - Severely impaired renal function, GFR < 30 ml/min - Participation in another drug or device study that would jeopardize the appropriate analysis of end-points of this study. - High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons) - Pregnancy |
Country | Name | City | State |
---|---|---|---|
Germany | Department of Medicine II - Cardiology, University Hospital Bonn | Bonn | |
Germany | Department of Cardiology, University Hospital Düsseldorf | Düsseldorf | |
Germany | West German Heart Center, University Hospital Essen | Essen | |
Germany | Department of Medicine III - Cardiology, University Hospital Heidelberg | Heidelberg | |
Germany | Department of Cardiology, Hospital Barmherzige Brüder Trier | Trier | |
Germany | Department of Medicine III - Cardiology, University Hospital Tübingen | Tübingen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bonn |
Germany,
Drews T, Pasic M, Buz S, Unbehaun A, Dreysse S, Kukucka M, Mladenow A, Hetzer R. Transcranial Doppler sound detection of cerebral microembolism during transapical aortic valve implantation. Thorac Cardiovasc Surg. 2011 Jun;59(4):237-42. doi: 10.1055/s-0030-1250495. Epub 2011 Mar 25. — View Citation
Ghanem A, Müller A, Nähle CP, Kocurek J, Werner N, Hammerstingl C, Schild HH, Schwab JO, Mellert F, Fimmers R, Nickenig G, Thomas D. Risk and fate of cerebral embolism after transfemoral aortic valve implantation: a prospective pilot study with diffusion-weighted magnetic resonance imaging. J Am Coll Cardiol. 2010 Apr 6;55(14):1427-32. doi: 10.1016/j.jacc.2009.12.026. Epub 2010 Feb 24. — View Citation
Grube E, Naber C, Abizaid A, Sousa E, Mendiz O, Lemos P, Kalil Filho R, Mangione J, Buellesfeld L. Feasibility of transcatheter aortic valve implantation without balloon pre-dilation: a pilot study. JACC Cardiovasc Interv. 2011 Jul;4(7):751-7. doi: 10.1016/j.jcin.2011.03.015. — View Citation
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Leon MB, Piazza N, Nikolsky E, Blackstone EH, Cutlip DE, Kappetein AP, Krucoff MW, Mack M, Mehran R, Miller C, Morel MA, Petersen J, Popma JJ, Takkenberg JJ, Vahanian A, van Es GA, Vranckx P, Webb JG, Windecker S, Serruys PW. Standardized endpoint definitions for Transcatheter Aortic Valve Implantation clinical trials: a consensus report from the Valve Academic Research Consortium. J Am Coll Cardiol. 2011 Jan 18;57(3):253-69. doi: 10.1016/j.jacc.2010.12.005. Epub 2011 Jan 7. — View Citation
Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22. — View Citation
Nuis RJ, Van Mieghem NM, Schultz CJ, Tzikas A, Van der Boon RM, Maugenest AM, Cheng J, Piazza N, van Domburg RT, Serruys PW, de Jaegere PP. Timing and potential mechanisms of new conduction abnormalities during the implantation of the Medtronic CoreValve System in patients with aortic stenosis. Eur Heart J. 2011 Aug;32(16):2067-74. doi: 10.1093/eurheartj/ehr110. Epub 2011 May 28. — View Citation
Sinning JM, Ghanem A, Steinhäuser H, Adenauer V, Hammerstingl C, Nickenig G, Werner N. Renal function as predictor of mortality in patients after percutaneous transcatheter aortic valve implantation. JACC Cardiovasc Interv. 2010 Nov;3(11):1141-9. doi: 10.1016/j.jcin.2010.09.009. — View Citation
Sinning JM, Scheer AC, Adenauer V, Ghanem A, Hammerstingl C, Schueler R, Müller C, Vasa-Nicotera M, Grube E, Nickenig G, Werner N. Systemic inflammatory response syndrome predicts increased mortality in patients after transcatheter aortic valve implantation. Eur Heart J. 2012 Jun;33(12):1459-68. doi: 10.1093/eurheartj/ehs002. Epub 2012 Jan 26. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary composite efficacy endpoint | Occurrence of all-cause mortality, stroke, non-fatal myocardial infarction, acute kidney injury, or pacemaker implantation at 30 days after TAVI. | 30 days after TAVI | |
Secondary | Cardiovascular & all-cause mortality | 6 months, 12 months after TAVI | ||
Secondary | Major/minor stroke | 6 months, 12 months after TAVI | ||
Secondary | Myocardial infarction | 6 months, 12 months after TAVI | ||
Secondary | conduction disturbances and pacemaker implantation rate | 6 months, 12 months after TAVI | ||
Secondary | Acute kidney injury | 6 months, 12 months after TAVI | ||
Secondary | Rate of postdilation | 30 days, 6 months, 12 months after TAVI | ||
Secondary | Transvalvular mean gradient as assessed by echocardiography | 30 days, 6 months, 12 months after TAVI | ||
Secondary | Re-hospitalization for symptoms of cardiac/valve-related decompensation | 30 days, 6 months, 12 months after TAVI | ||
Secondary | Severity of periprosthetic aortic regurgitation (AR) as assessed by echocardiography, angiography, and hemodynamic measurements (AR index) | 30 days, 6 months, 12 months after TAVI | ||
Secondary | Life-threatening/major/minor bleeding | 30 days, 6 months, 12 months after TAVI | ||
Secondary | Vascular access complications | 30 days, 6 months, 12 months after TAVI | ||
Secondary | Repeat procedure for valve-related dysfunction (surgical or interventional therapy) | 30 days, 6 months, 12 months after TAVI |
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