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van CCT (UK)

van CCT (UK)

DIagnostic and prognostic value of intracoronary physiologic indices and need for revascularisation in severe aortic VAlve disease (DIVA)

- candidate number25522
- NTR NumberNTR6520
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-nov-2016
- Secondary IDs2017_005 METC
- Public TitleDIagnostic and prognostic value of intracoronary physiologic indices and need for revascularisation in severe aortic VAlve disease (DIVA)
- Scientific TitleDIagnostic and prognostic value of intracoronary physiologic indices and need for revascularisation in severe aortic VAlve disease (DIVA)
- hypothesis- FFR is a valid measurement to determine hemodynamic severity of coronary stenoses in patients with severe aortic stenosis
- FFR-guided PCI with concommitant TAVI reduces MACE and revascularisations
- Healt Condition(s) or Problem(s) studiedAortic valve stenosis, Coronary artery disease
- Inclusion criteria- Patients with severe (senile) aortic stenosis (AVA <1,0cm, mean gradient >40mm and maximum jet velocity >4 m/s or or aortic valve area index 0.6 cm2/m2.)
- Patients are non-eligible for conventional surgical aortic valve replacement due to age, medical history or co-morbidity and thus eligible for T(F)-AVI as decided by the heart-team.
- Patient has coronary artery disease as depicted on screening CAG (defined as 1 coronary stenosis >50%)
- Patient understands the study requirements and the treatment procedures, and provides written informed consent.
- Patient agrees and is capable of returning to the study hospital for all required scheduled follow up visits
- Exclusion criteria- Patient is able to give informed consent
- Absence of coronary artery disease (defined as 1 coronary stenosis >50% as depicted on coronary arteriogram during TAVI-screening)
- Subjects with an acute STEMI within 30 days preceding the index procedure (TAVI).
- Inability to get per procedural reliable, intracoronary measurements (due to place of lesion, unreliable signals, mechanical defects etc.)
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2017
- planned closingdate31-dec-2019
- Target number of participants210
- InterventionsFFR-guided PCI after TAVI; re-catheterisation 2 months after TAVI-procedure
- Primary outcome- MACE (A composite of all cause death, documented MI and any revascularisation (urgent/non-urgent).
- Secondary outcome- Overall MACE (cost and cost effectiveness, functional class, number of anti-anginal medication, rate of non-urgent revascularization, and rate of cerebrovascular event),
- Standard follow-up criteria (physical examination, ECG, standard laboratory tests)
- Valve function and left ventricular function parameters (as measured with cardiac ultrasonography),
- Cardiac symptoms (dyspnoea (New York Heart Association/ NYHA classification),
- angina pectoris (Canadian Cardiologist Society/ CCS score),
- quality of life (QoL).
- Timepoints+6-8 weeks after TAVI-procedure
+12 months after TAVI procedure
- Trial web site
- statusplanned
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Amsterdam
- Publications
- Brief summaryAortic stenosis (AS) is a disease which predominantly prevails in the elderly population, often accompanied by (stable) coronary artery disease (CAD). Established intracoronary flow- and pressure measurements (FFR, CFR, MR) to assess coronary hemodynamic and the severity of - and need for revascularisation of atherosclerotic coronary lesions are not yet fully understood (and not validated) for use in patients with concomitant diseases. Furthermore, there is no definite data on whether or not to treat CAD in patients who will undergo TAVI regarding symptoms and prognostic value.

This RCT (2x105 pts) will investigate diagnostic and prognostic value of FFR in patients who undergo TAVI for their severe aortic valve stenosis. It will make clear the symptomatic and prognostic value of revascularisation in patients with AS and concommitant CAD.
- Main changes (audit trail)
- RECORD10-nov-2016 - 14-jul-2017

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