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Intervent-TAVI

Prospective study evaluating minimally invasive interventions for high-grade aortic valve stenosis

  • Study directors:

    • Univ.-Prof. Dr. med. Philipp Wild, M.Sc. (coordinating)
    • Univ.-Prof. Dr. med. Thomas Münzel

Subject

Transcatheter aortic valve implantation (TAVI) for severe symptomatic aortic valve stenosis

Study design

Observational, prospective, multicenter cohort study

Study participants

Patients meeting the following inclusion criteria:

  • ≥ 18 years of age and signed written consent
  • Planning of interventional procedure for severe symptomatic aortic valve stenosis

Status

Ongoing
Recruiting since April 2016

Objectives

  • Evaluation of clinical management strategies;
  • Optimizing eligibility and risk stratification for interventional procedures;
  • Evaluation of results of interventional procedures;
  • Examination of genetic patterns and biomolecular markers for their prognostic impact on outcome in a holistic approach, including lifestyle, environment, cardiovascular risk profile and disease status;
  • Establish a long-term resource for comprehensive research on interventional procedures for cardiovascular disease

Study procedure

Duration of study per participant: 10 years

  • Disease-related check-ups after one and twelve months
  • Annual telephone interviews for up to 5 years after study inclusion
  • Passive follow-up up to 10 years

Summary

Cardiovascular diseases are a major health burden, accounting for approximately 45% of all deaths in the European Region. Treatment options for patients include interventional procedures, such as transcutaneous implantation of an aortic valve. Catheter-based treatments are undergoing a steady evolution in methodology as well as prostheses and are being made available to a larger patient population.

INTERVENT-TAVI is a prospective, multicenter study designed to advance knowledge of transcutaneous aortic valve implantation with the goal of reducing mortality and improving long-term patient quality of life. It is part of a program to evaluate interventional procedures for cardiovascular diseases.

The project is conducted with a systematic assessment of patient characteristics, risk profile and procedure-related aspects (complications, benefits). The goal is to evaluate the results of interventional procedures to optimize risk stratification and clinical management strategies.
Using a holistic approach, the study examines genetic patterns and biomolecular markers for their prognostic impact on results.

The establishment of a detailed research data bank as well as a biobank with standardized methods for data collection will serve as a resource for comprehensive research on interventional procedures in cardiovascular diseases.

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