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OpenTrials
Completed

NCT Number: NCT03343314

Effective Management of Calcific Aortic Stenosis in the Elderly

Although aortic valve replacement is recommended for any symptomatic severe calcific aortic stenosis, the therapeutic decision may be difficult. because of patient age and comorbidities.

Transcatheter Aortic Valve Implantation (TAVI) has recently extended the therapeutic indications in patients at high risk of surgery. However, the proportion of different treatments is not known in a contemporary population that can be treated according to the different resources currently available.

The scientific goal of this observational research is to evaluate intra-hospital therapeutic decision in elderly patients referred because of symptomatic severe aortic stenosis.

The one-year survival will be analyzed according to the therapeutic decision and the characteristics of the patients.

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Key information

Conditions

Calcific Aortic Stenosis Aortic Valve, Calcification of

Age range

75 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hospitalized due to symptomatic tight aortic stenosis (NYHA >= II, dyspnea, angina or syncope);
  • Having given his consent to participate in the study.

Exclusion criteria

  • Non-severe aortic stenosis;
  • Asymptomatic aortic stenosis;
  • Patient under the age of 75;
  • Patient refusing to participate in the study.

Treatment and study plan

Primary outcomes

  1. Collate the therapeutic decision (medical treatment, TAVI [Transcatheter Aortic Valve Implantation] or surgical aortic valve replacement) comprehensively for all hospitalized patients because of a severe, symptomatic RAC.

    Time frame: 1 day

    The primary endpoint is the therapeutic indication retained by the medical-surgical team in charge of the patient during hospitalization: medical treatment, TAVI or surgical aortic valve replacement.

Secondary outcomes

  1. 1 year-survival

    Time frame: 1 year

    Survival at one year will be analyzed. The analysis of the relationship between therapeutic decision and survival will be studied by taking surgical aortic valve replacement as a reference class.

Sponsors and collaborators

Lead sponsor

French Cardiology Society

Other

Registry information

Acronym: RAC

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Nov 17, 2017
Registry last updated
Aug 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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