Effective Management of Calcific Aortic Stenosis in the Elderly

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03343314

Acronym

RAC

Enrollment

1101

Registered

2017-11-17

Start date

2016-09-30

Completion date

2018-12-31

Last updated

2019-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Calcific Aortic Stenosis

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

75 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.	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

Measure	Time frame	Description
1 year-survival	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.

Outcome results