Is Mitral Annuloplasty an Effective Treatment for Severe Atrial Functional MR? (NCT05836376) | Clinical Trial Compass
CompletedNot Applicable
Is Mitral Annuloplasty an Effective Treatment for Severe Atrial Functional MR?
Italy55 participantsStarted 2020-11-30
Plain-language summary
Atrial functional mitral regurgitation (MR) is caused by annular dilatation and flattering associated with altered atria/annulus dynamics in patients with severely dilated left atrium and normal leaflets anatomy. Inadequate leaflets adaption is considered a mechanistic culprit as well. Prevalence of at least moderate atrial functional MR varies between 4.7% and 7% in patients with permanent and long standing persistent atrial fibrillation (AF) and is even higher in patients with Heart Failure with preserved Ejection Fraction (HFpEF). Unlike secondary MR in the setting of left ventricular disease, results of surgical treatment of severe atrial functional MR has remained largely unspoken.
The aim of this study is to analyze short and mid-term results of isolated annuloplasty in patients with severe, symptomatic atrial functional MR, in comparission to a matched cohort of patients with secondary MR.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Atrial MR group Inclusion criteria
* Adult patients, underwent mitral annuloplasty for atrial functional mitral Anatomical criteria
* Annular dilatation with anterior-posterior diameter (AP) in systole \>35mm
* Ratio of AP diameter in systole to anterior leaflet length in diastole \>1.3
* Normal leaflets anatomy
* Mild fibrosis may be present
* A small cleft may be present as a result of annular dilatation Functional criteria
* Normal leaflet mobility (Carpentier type I)
* Coaptation depth \<10mm
* Absence of ventricular tethering
* Centrality of the regurgitant jet Atrial and ventricular characteristics
* Left atrium diameter \> 40 mm
* Normal systolic function of the left ventricle
* Mild left ventricular systolic dysfunction Mild LV (tachycardia induced) with EF \>45%
* Absence of regional abnormalities in left ventricular wall motion Clinical criteria
* Persistent, long-standing persistent, or permanent atrial fibrillation
Exclusion criteria
* Degenerative MR including congenital clefts
* LVEF \< 45%
* Ventricular tethering
* Coaptation depth \>10 mm
* Regional abnormalities in left ventricular wall motion
* Sinus rhythm
* Presence of coronary artery disease
* Absence of annular dilatation
Non-atrial MR group Inclusion criteria
* Adult patients underwent cardiac surgery for non-atrial functional mitral regurgitation in the setting of an idiopathic or ischemic cardiomyopathy
Exclusion criteria
* FE\<40%
* Concomitant coronary artery bypass graft
* Age \<65 years and…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.