Functional Assessment In TAVI: FAITAVI

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

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