Aortic Valve Stenosis Clinical Trial
— DAPT-TAVIOfficial title:
Dual AntiPlatelet Therapies for Prevention of Periinterventional Embolic Events in Transcatheter Aortic Valve Implantation (TAVI)
TAVI is increasingly adopted as standard treatment for many subgroups of patients with
aortic stenosis. However, due to a lack of data there is yet no TAVI-specific guidance
regarding the optimum periinterventional drug regimen.
The study evaluates the effect of dual antiplatelet pretreatment on periinterventional
embolic cerebral lesions and bleeding complications in patients undergoing transfemoral
aortic valve implantation (TF-TAVI).
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | April 2018 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria: - Patients >18 years and <90 years - Patients undergoing TF-TAVI for severe aortic stenosis (combined with aortic regurgitation) - Informed consent Exclusion criteria: - TIA/Stroke within last 90 days - Aortic valve-in-valve procedures - TAVI for treatment of isolated aortic regurgitation - known significant carotid stenosis (>70%) - Prior myocardial infarction or revascularization with PCI or CABG within past 3 months - Clopidogrel and/ or Aspirin within past 7 days - any other indication for (dual) antiplatelet therapy - Contraindication to MRI (MRI conditional pacemakers accepted!) - participation in another interventional trial - cardiogenic shock (positive shock index OR need for catecholamine support OR systolic bloodpressure < 90 mmHg) or need for pre-hospital intubation - cardiac arrest <90 days prior to randomization - Pregnant or lactating females |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Charite University, Berlin, Germany | PD Dr. David Leistner, Charite University, Department of Cardiology, Berlin, Germany, Prof. Dr. Jochen Fiebach, Center for Stroke Research Berlin (CSB), Charité - Universitaetsmedizin Berlin, Prof. Dr. Ulf Landmesser, Charite University, Department of Cardiology, Berlin, Germany |
Holmes DR Jr, Brennan JM, Rumsfeld JS, Dai D, O'Brien SM, Vemulapalli S, Edwards FH, Carroll J, Shahian D, Grover F, Tuzcu EM, Peterson ED, Brindis RG, Mack MJ; STS/ACC TVT Registry.. Clinical outcomes at 1 year following transcatheter aortic valve replacement. JAMA. 2015 Mar 10;313(10):1019-28. doi: 10.1001/jama.2015.1474. — View Citation
Osnabrugge RL, Mylotte D, Head SJ, Van Mieghem NM, Nkomo VT, LeReun CM, Bogers AJ, Piazza N, Kappetein AP. Aortic stenosis in the elderly: disease prevalence and number of candidates for transcatheter aortic valve replacement: a meta-analysis and modeling study. J Am Coll Cardiol. 2013 Sep 10;62(11):1002-12. doi: 10.1016/j.jacc.2013.05.015. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total volume of new cerebral lesions on MRI after TAVI versus Baseline | Total volume of new cerebral lesions on MRI, 24-72h after TAV versus Baseline | Yes | |
Secondary | New lesion volume of cerebral embolization in patients treated with ASS and Clopidogrel before versus after TAVI | Total new lesion volume is defined as the sum volume of all new cerebral ischemic lesions on the post-procedural MRI relative to the pre-TAVR cerebral MRI scan (on diffusion weighted and FLAIR MRI images). | 24-72h post TAVI versus baseline | Yes |
Secondary | location of new cerebral lesions early AFTER TAVI | To evaluate cerebral embolisation, which is not procedure related, cerebral embolisation on MRI will be before TAVI versus the post-TAVI MRI scan | 24-72h after TAVI | No |
Secondary | extent of new cerebral lesions early AFTER TAVI | To evaluate cerebral embolisation, which is not procedure related, cerebral embolisation on MRI will be before TAVI versus the post-TAVI MRI scan | 24-72h after TAVI | No |
Secondary | Assessment of different neurocognitive tests before and after TAVI procedure | To evaluate neurologic function with a battery of neurocognitive tests and to correlate these findings to cerebral MRI scans | 24-72 h after TAVI | No |
Secondary | Extent of clinically apparent non-cerebral emboli after TAVI | To describe extent and localization of non-cerebral embolisation (e.g. pulmonary embolism, limb ischaemia...) | 24-72 h after TAVI | No |
Secondary | localization of clinically apparent non-cerebral emboli after TAVI | To describe extent and localization of non-cerebral embolisation (e.g. pulmonary embolism, limb ischaemia...) | 24-72 h after TAVI | No |
Secondary | Evaluation of possible changes in quality of life after TAVI with EQ-5D questionnaire sum score. | 24-72 h after TAVI | No |
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