Effective Management of Calcific Aortic Stenosis in the Elderly (RAC)

August 6, 2019 updated by: French Cardiology Society

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Multicenter study to prospectively include all patients who agreed to participate in the study, with severe and symptomatic aortic stenosis, and hospitalized in one of the medical-surgical centers participating in the study and offering all the therapeutic resources for the taking into account charge of patients with aortic stenosis

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Hospitalized patients due to a severe, symptomatic aortic sten
Patients who agreed to participate in the study, aged ≥75 years, with severe and symptomatic aortic stenosis, and hospitalized in one of the medical and surgical centers participating in the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Cardiology Society

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

November 10, 2017

First Submitted That Met QC Criteria

November 14, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

August 7, 2019

Last Update Submitted That Met QC Criteria

August 6, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15945

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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