Gender-specific Evaluation of Symptom Awareness in Female Versus Male Patients with Severe Aortic Stenosis

NCT06677528 | Active Not Recruiting

• 1 other identifier: HDZ-KA_022_TR
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 2

Brief Summary

The objectives of this single center cross-sectional cohort study are to compare symptoms and disease perception of male and female patients with severe aortic stenosis.

Conditions

Aortic Stenosis; Female; Male

Outcome Measures

Primary Outcomes (1)

• Questionnaires completed

  From enrollment to the end of FU at 4 weeks

Study Arms (1)

Patients undergoing TAVR or SAVR

Other: Questionnaire

Interventions

Questionnaire OTHER

Questionnaire on Aortic Valve Disease, HADS-D, SCL-27, MLHFQ

Patients undergoing TAVR or SAVR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

About n=800 Patients who are admitted for surgical or interventional replacement of aortic stenosis complete the following questionnaires: 1. HADS - D 2. SCL - 27 3. MLHFQ 4. Demographic data 5. AWARE - Symptoms of aortic stenosis

You may qualify if:

• Indication for surgical or interventional aortic valve replacement for aortic stenosis as consented by the local heart team
• Age\> 18 years
• Patient is willing and able to complete the surveys in German language

You may not qualify if:

• Additional procedures such as coronary bypass surgery, any surgery on another than the aortic valve, aortic surgery
• PCI performed within the last 30 days

Sponsors & Collaborators

• Heart and Diabetes Center North-Rhine Westfalia: lead

Study Sites (2)

Clinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum NRW

Bad Oeynhausen, 32545, Germany

Location

Clinic for Thoracic and Cardiovascular Surgery, Herz- und Diabeteszentrum NRW

Bad Oeynhausen, 32545, Germany

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 6, 2024
• Study Start: July 31, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 6, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)