Atrial Functional MR and TR

Sponsor

Barts & The London NHS Trust (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05920824

Collaborator

(none)

140

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Atrial fibrillation (also called AF) is a type of irregular heartbeat that can lead to problems with blood flow. The normal heart beats in a regular pattern, with the upper chambers (called the atria) contracting and then relaxing to push blood into the lower chambers (called the ventricles), which then contract to pump blood out to the rest of the body. In atrial fibrillation, however, the atria don't contract in a coordinated way - instead, they quiver or twitch rapidly and irregularly. Atrial fibrillation can lead to leaky heart valves through a process called atrial remodeling. The quivering or twitching of the atria can cause changes in the structure and function of the heart, including the mitral and tricuspid valves.

This study aims to find out what factors increase the chances of a valve problem developing or getting worse and how it could affects patient health.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Functional Mitral Regurgitation Functional Tricuspid Regurgitation	Diagnostic Test: Echocardiogram

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

140 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Clinical Phenotypes, Risk Factors, & Determinants of Outcome in Functional Mitral and Tricuspid Valve Regurgitation

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2026

Anticipated Study Completion Date :

Feb 1, 2027

Outcome Measures

Primary Outcome Measures

Effective Regurgitant Orifice Area at 1 year [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Informed consent Age of 18 years or older Atrial fibrillation Moderate or severe atrial valve disease Adequate 2D echocardiography views including parasternal long axis, short axis, apical two chamber, apical three chamber and four chamber.

Exclusion Criteria:

Unwilling or unable to give consent Left ventricular impairment (ejection fraction < 50%). Primary/organic valve disease

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Barts & The London NHS Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Barts & The London NHS Trust

ClinicalTrials.gov Identifier:

NCT05920824

Other Study ID Numbers:

326447

First Posted:

Jun 27, 2023

Last Update Posted:

Jun 27, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Atrial Fibrillation

Mitral Valve Insufficiency

Tricuspid Valve Insufficiency

Study Results

No Results Posted as of Jun 27, 2023