EffecTAVI Registry – CheckOrphan

Brief Title

EffecTAVI Registry

Official Title

Safety and Effectiveness of Transcatheter Aortic Valve Implantation - EffecTAVI Registry

Brief Summary

      Aortic stenosis (AS) is the most common valvular heart disease among elderly population, with
      a increasing prevalence due to population ageing. In developed countries, the prevalence of
      severe AS among ≥75 years is approximately 3.4%. The onset of symptoms is associated with a
      poor prognosis. Indeed, mortality increases once symptoms appears.

      For several decades, surgical aortic valve replacement (SAVR) has been the standard of care
      for symptomatic AS. Transcatheter aortic valve implantation (TAVI) was introduced as
      alternative treatment in inoperable patients in 2002. In the last two decades TAVI has led to
      a paradigm shift in the treatment of severe AS, representing a less invasive alternative to
      surgery. TAVI has shown to be non-inferior or superior to SAVR in several large-scale
      randomized clinical trials (RCTs) across the full spectrum of surgical risks. The newly
      available evidence has led to an expansion of guideline recommendations for TAVI.
      Furthermore, newer generations of transcatheter heart valve (THV) design, better patient
      selection, and technical enhancements have driven improvement in safety and reduction of
      procedural complications over time.

      This observational study aim to prospectively evaluate the safety and efficacy of the
      procedure and clinical outcomes in patients undergoing TAVI.

Detailed Description

Aortic stenosis (AS) is the most common valvular heart disease among elderly population, with
a increasing prevalence due to population ageing. In developed countries, the prevalence of
severe AS among ≥75 years is approximately 3.4%. The onset of symptoms is associated with a
poor prognosis. Indeed, mortality increases once symptoms appears.

For several decades, surgical aortic valve replacement (SAVR) has been the standard of care
for symptomatic AS. Transcatheter aortic valve implantation (TAVI) was introduced as
alternative treatment in inoperable patients in 2002. In the last two decades TAVI has led to
a paradigm shift in the treatment of severe AS, representing a less invasive alternative to
surgery. TAVI has shown to be non-inferior or superior to SAVR in several large-scale
randomized clinical trials (RCTs) across the full spectrum of surgical risks. The newly
available evidence has led to an expansion of guideline recommendations for TAVI.

This observational study aim to prospectively evaluate the safety and efficacy of the
procedure and clinical outcomes in patients undergoing TAVI.

EffectTAVI is an observational, monocentric registry promoted by Department of Advanced
Biomedical Sciences of University of Naples Federico II.

The aim is to collect clinical, procedural, echocardiographic data and to evaluate the
clinical outcomes of TAVI procedure.

Study population: consecutive patients with symptomatic severe AS candidate to TAVI,
established by the multi-disciplinary Heart Team according to current guidelines
recommendations.

Severe AS will be defined according to the following echocardiographic criteria:

- Aortic valve area: < 1 cm2

- Indexed aortic valve area: < 0,6 cm2/m2

- Mean aortic valve gradient: ≥ 40 mmHg

- Peak aortic jet velocity: ≥ 4,0 m/sec

TAVI can be performed using several arterial access: transfemoral, transapical,
trans-subclavian and trans-aortic.

Written informed consent will be obtained for all patients for participation in this
registry.

After hospital discharge, clinical follow-up will be performed at 30-day, 6 months and 1-year
after TAVI. All adverse events were systematically collected and classified according to the
definitions of the Valve Academic Research Consortium (VARC)-3 criteria.

Clinical, procedural and follow-up data will be anonymously entered in a web-based database
RedCap (https://www.redcap.unina.it/redcap/). Patients will be entered with a pseudonym
generated by the data collection system.

The pseudonym does not allow the identification of the patient and, therefore, meets the
European criteria for the acquisition of data online.

The access to the online database is allowed through the use of a personal password, provided
to the Primary Investigator and to the Co-Investigators involved in the study.

Data analysis will be performed by the investigators of the Department of Advanced Biomedical
Sciences.

The extensive case studies that investigators expect to collect will be useful to establish
clinical, procedural and follow-up data in short, medium and long term of patients with
severe aortic stenosis undergoing TAVI.

Study Type

Observational [Patient Registry]

Primary Outcome

All cause mortality

Secondary Outcome

 Cardiovascular mortality

Condition

Aortic Stenosis

Intervention

Transcatheter heart valve (THV) with CE approval

Study Arms / Comparison Groups

 Patients with symptomatic severe AS undergoing TAVI.

Description:

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

September 1, 2015

Completion Date

January 1, 2030

Primary Completion Date

September 9, 2021

Eligibility Criteria

        Inclusion Criteria:

          1. Patients with symptomatic severe AS or degenerated bioprosthetic aortic valve and
             suitable for TAVI according to Heart Team evaluation;

          2. Ability to provide informed consent.

        Exclusion Criteria:

          1. Contraindications to TAVI: e.g. evidence of intracardiac mass, thrombus or vegetation,
             endocarditis;

          2. Poor adherence to scheduled follow-up;

          3. Unable to understand and follow study-related instructions.

Gender

All

Ages

55 Years - 100 Years

Accepts Healthy Volunteers

No

Contacts

Giovanni Esposito, MD, PhD, +390817463075, [email protected]

Location Countries

Italy

Location Countries

Italy

Administrative Informations

NCT ID

NCT05235555

Organization ID

231/18

Responsible Party

Principal Investigator

Study Sponsor

Federico II University

Study Sponsor

Giovanni Esposito, MD, PhD, Principal Investigator, Federico II University

Verification Date

February 2022