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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29366

Enrollment

210

Registered

2016-11-10

Start date

2017-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe aortic valve stenosis Coronary artery disease

Interventions

FFR-guided PCI after TAVI

re-catheterisation 2 months after TAVI-procedure

Eligibility

Inclusion criteria

Inclusion criteria: - Patients with severe (senile) aortic stenosis (AVA 40mm and maximum jet velocity >4 m/s or or aortic valve area index ¡Ü0.6 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 ¡Ý1 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

Exclusion criteria: - Patient is able to give informed consent - Absence of coronary artery disease (defined as ¡Ý1 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.)

Design outcomes

Primary

Measure	Time frame
-MACE (A composite of all cause death, documented MI and any revascularisation (urgent/non-urgent).	—

Secondary

Measure	Time frame
- 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).	—

Measure

Time frame

- 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).

—

Contacts

Public ContactJeroen Vendrik

Meibergdreef 9 (Academical Medical Centre Amsterdam)

j.vendrik@amc.uva.nl+31 (0)20 566 5204 / +316 46032024

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)