Biatrial Contractility Recovery After Maze

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

122 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aimed at evaluating multiple aspects of biatrial contractility recovery after modified maze procedure during mitral valve surgery.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Atrial fibrillation (AF) is a frequent complication in patients affected by mitral valve disease, causing systemic embolism, cardiac chamber dilation and decreased cardiac output. Cox et al. have designed the maze procedure as a surgical treatment for patients with AF in whom conventional therapy has failed and their lesion set is nowadays currently performed with different energy sources in order to surgically treat such supraventricular arrhythmia. In particular, the original maze was designed with three specific goals in mind: 1) the permanent AF ablation 2) the restoration of atrioventricular synchrony and 3) the preservation of atrial transport function (1). If , by one side, the efficacy of the procedure in reaching the first two goals are widely known, the restoration of the sinus rhythm does not always accompany the corresponding recovery of atrial mechanical "kick". If the atrial transport function fails to recover, benefits deriving from arrhythmia abolition might only be marginal, since, by one side, blood stasis in the atria persist, thus maintaining unchanged thromboembolic risk and, by the other side, heart hemodynamic performance is still impaired resulting from the loss of atrial contribution to cardiac output. Despite its relevant role for judging maze comprehensive success, atrial contractility outcome and clinical importance have not been deeply investigated. The purposes of this study were to evaluate by serial transthoracic echocardiography temporal modality of biatrial contractility restoration, predictive factors of atrial transport recovery and its possible relationship with cardiac chambers dimensions and function evolution after radiofrequency (RF) maze during mitral surgery.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Radiofrequency maze procedure

RF energy was used to create continous endocardial and epicardial lesions mimicking most of the left atrial incisions set as described in the Cox Maze III procedure. In all patients a bipolar device was used (Cardioblate BP2 Irrigated RF Surgical Ablation System®, Medtronic Inc, Minneapolis, MN, USA).

Intervention Type PROCEDURE

Transthoracic echocardiography

Contemporary to clinical follow up, all patients were evaluated with 2-dimensional transthoracic echocardiography (Philips ultrasound system (iE33®, Andover, MA, USA)) at 3,6,12,24 months in order to specifically monitor the evolution of cardiac chambers dimensions and systolic performance and to record left and right atrial contractility presence.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients affected by atrial fibrillation undergoing mitral valve surgery

Exclusion Criteria

* Other cardiac procedures in addition to mitral valve surgery

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Claudia Loardi

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Claudia Loardi, MD

Role: PRINCIPAL_INVESTIGATOR

Centro Cardiologico Monzino Milano - Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ACFA1

Identifier Type: -

Identifier Source: org_study_id