Brief Title
Functional Assessment In TAVI: FAITAVI
Official Title
Functional Assessment In TAVI: FAITAVI
Brief Summary
The aim of this study is to compare the clinical outcome of patients with severe aortic valve
stenosis and associated significant coronary artery disease treated with TAVI and a
percutaneous myocardial revascularization dictated according to two different strategies:
1. the Angiographically-guided strategy;
2. the Physiologically-guided strategy.
Detailed Description
Nowadays there are no clear recommendations about treatment of coronary in patients with
severe aortic valve stenosis eligible for percutaneous valve replacement, and those available
rely on a "common sense", class C, level of evidence. No randomized trials debride the skein
about the best strategy of revascularization in this complex group of patients. In
particular, it remains unclear whether it is preferable a preventive treatment or an
ischemia-driven revascularization and, in addition, if it is safer and better for patient's
health a simultaneous or a staged strategy.
The aim of this study is to compare the clinical outcome of patients with severe aortic valve
stenosis and associated significant coronary artery disease treated with TAVI and a
percutaneous myocardial revascularization dictated according to two different strategies.
The Angiographically-guided strategy is that of aiming the most complete degree of
revascularization based on angiographic evaluation (stenting all coronary stenosis of major
branches >2.5mm, with a %DS>50% as evaluated by visual estimation).
The Physiologically-guided strategy is that of treating only lesions with FFR ≤0.80, and
leaving on optimal medical treatment lesions with FFR >0.80. The iFR values will be recorded
in all patients, and verified in the core laboratory to allow a post-hoc analysis correlating
the 0.80 FFR cut-off with different iFR cut-off values, according to recent observations and
using the same study end-points.
Particular attention will be dedicated to the eventual occurrence of clinical events in
patients deferred on the bases of FFR values >0.80 that show a discrepancy with positive
(<0.89) iFR values to investigate the reliability of the FFR in the Aortic Stenosis setting.
Both groups will receive the same TAVI strategy and optimal medical therapy. The study is
designed as randomized, prospective, multi.center, open label, experimental trial with
medical device. After discharge patients will be contacted at 30 days, 6 - 12 and 24 months
after the procedure to assess the general clinical status and at 12 months to assess the
occurrence of events included in the primary and secondary endpoints. The duration of study
participation is 24 months for enrolment, ad 24 months for final follow-up.
Study Type
Interventional
Primary Outcome
Incidence of the treatment
Secondary Outcome
Safety endpoint
Condition
Coronary Artery Disease
Intervention
Physiologically-guided strategy
Study Arms / Comparison Groups
Physiologically-guided strategy
Description: Patients randomized in this group will undergo stenting of coronary lesions showing FFR values ≤0.80 only. Lesions showing positive FFR measurements (<0.80) must be treated with PCI, before or after TAVI. Lesions showing clearly negative values (FFR >0.80) will not be treated with PCI before TAVI, and repeated FFR and iFR measurements after TAVI are strongly recommended. Lesions showing "borderline" FFR measurements before TAVI (FFR 0.80-0.83), should be measured again (both FFR and iFR) after TAVI, and the decision of treating of deferring treatment in a given lesion will be based on the FFR value obtained after TAVI. In all cases iFR values will be recorded for a post hoc analysis and for validation of the study endpoints according to iFR values.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
320
Start Date
November 24, 2017
Completion Date
December 31, 2021
Primary Completion Date
November 24, 2020
Eligibility Criteria
Inclusion Criteria:
1. Age > 18 years
2. Written informed consent
3. Diagnosis of severe native aortic valve disease with the indication to endovascular
valve replacement given by Heart Team
4. Diagnosis of at least one coronary stenosis >50% at angiography
5. No specific pharmacologic treatment is required to enter the study
Exclusion Criteria:
1. Age < 18 years
2. Pregnancy
3. Lack of informed consent
4. Impaired left ventricular function
5. Signs or symptoms of acute (unstable) myocardial ischemia
6. Contraindication to adenosine administration (e.g., asthma, chronic obstructive
pulmonary disease, heart rate <50 beats/min, and systolic blood pressure <90 mmHg)
7. Reduced survival expectancy due to severe co-morbidities (<1 year)
8. Impossibility to obtain follow-up information
9. The lack of any of inclusion criteria
Gender
All
Ages
18 Years - 90 Years
Accepts Healthy Volunteers
No
Contacts
, +39 045 812, [email protected]
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT03360591
Organization ID
FAITAVI
Responsible Party
Principal Investigator
Study Sponsor
Universita di Verona
Study Sponsor
, ,
Verification Date
December 2017