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Future Optimal Research and Care Evaluation - Aortic Stenosis

NCT ID: NCT06168123

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-27

Study Completion Date

2027-08-01

Brief Summary

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In the past decade the treatment of aortic valve stenosis has rapidly changed. At first, transcatheter aortic valve implantation (TAVI) was a last resort option for inoperable patients. Nowadays, it more and more becomes an alternative to surgical aortic valve replacement (SAVR) - also in younger and lower risk patients. This poses important questions to clinical practise regarding the optimal life-time management of each individual patient. Which involves (durability of) treatment modality (surgical vs. transcatheter vs. conservative treatment) as well as the duration and type of the required antithrombotic treatment.

Objective: to evaluate the effect of treatment modality (surgical vs. transcatheter vs. conservative treatment) and its complications on quality of life and survival in AoS patients.

Detailed Description

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Conditions

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Severe Aortic Valve Stenosis Moderate Aortic Valve Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Quality of life questionnaires will be assessed in addition to standard care

Quality of life questionnaires will be assessed in addition to standard care

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Older than 18 years of age
* Severe or moderate aortic stenosis
Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Antonius Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jurriën M. ten Berg, MD, PhD

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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St. Antonius Hospital

Nieuwegein, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Christiaan Overduin

Role: CONTACT

[email protected]
+31 (0)88 320 0931

Facility Contacts

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Jurrien ten berg, MD PhD

Role: primary

Other Identifiers

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Z23.069

Identifier Type: -

Identifier Source: org_study_id