Visual Universitätsmedizin Mainz

AVIVA

Prospective study on the interventional procedure of percutaneous atrioventricular valve reconstruction (AVIVA)

  • Study directors:

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

Subject

Percutaneous valve repair for severe mitral and/or tricuspid valve insufficiency in high-risk patients

Study design

Observational, prospective cohort study

Study participants

Patients meeting the following inclusion criteria:

  • ≥ 18 years of age and signed written consent
  • Planned interventional valve repair for severe mitral and/or tricuspid insufficiency

Status

Pending

Objectives

  • Evaluation of the results of interventional procedures
  • Optimization of risk stratification for interventional procedures
  • Evaluation of clinical management strategies
  • 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
  • Establishment of a long-term resource for comprehensive research on interventional procedures for cardiovascular disease

Study course

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 non-surgical interventional procedures, such as catheter-based heart valve treatments, which have now been in use for more than 15 years. These interventional treatment methods are undergoing continuous development, are being adapted for the treatment of other cardiac diseases - for example, mitral valves have been treated this way for about ten years - and are being made available to a larger patient population.

The prospective cohort study AVIVA is designed to evaluate interventional procedures for the reconstruction of atrioventricular heart valves, that is mitral and tricuspid valves. It includes a systematic recording of patient characteristics, risk profile and procedure-related aspects (complications, benefits) as well as the establishment of a detailed biobanking.

The goal is to optimize risk stratification for these percutaneous interventional procedures, evaluate clinical management strategies and outcomes of interventional procedures. In a holistic approach, effects of sociodemographic, environmental and personal factors, as well as lifestyle, are captured as determinants of outcome and analyzed systemically. Comorbidities, genetic patterns and biomolecular markers are assessed for prognostic value. Finally, a long-term data and materials bank will be established for comprehensive research on interventional procedures for valvular heart disease.

AVIVA will improve knowledge of catheter-based percutaneous interventions for atrioventricular valve regression. This will allow for a reduction in mortality and a long-term improvement in the quality of life of these patients.

Harmonizing data assessment across cohorts of additional interventional treatment studies using standardized data collection methods will allow for research questions to be examined across cohorts and compared with population-based samples.

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