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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05009589
Other study ID # 2021-07
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 14, 2021
Est. completion date October 7, 2022

Study information

Verified date January 2023
Source Edwards Lifesciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will screen for the presence of cardiovascular disease and provide education about the signs and symptoms of cardiovascular disease and heart disease.


Recruitment information / eligibility

Status Completed
Enrollment 552
Est. completion date October 7, 2022
Est. primary completion date October 7, 2022
Accepts healthy volunteers
Gender All
Age group 50 Years and older
Eligibility Key Eligibility Criteria: 1. at least 50 years of age on the day of the screening event 2. informed of the nature of the study, agrees to its provisions, and has provided written informed consent 3. does not have any conditions that would interfere with obtaining an echocardiogram of the heart

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Lifewellness Institute San Diego California

Sponsors (1)

Lead Sponsor Collaborator
Edwards Lifesciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Abnormal structural heart findings The number of patients with abnormal structural heart findings as identified by echocardiography 30 days
Primary Abnormal electrocardiography findings The number of patients with abnormal electrocardiography findings such as rhythm disturbances, bundle branch or fascicular block, or other conduction delays 30 days
Primary Risk factors associated with cardiovascular disease Risk factors associated with cardiovascular disease including obesity (BMI and BSA calculations using height and weight) and blood pressure, along with personal and familial medical history. 30 days
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