Clinical trial NCT02321020: Follow up of Radiofrequency Maze in Mitral Patients
Official title: Sinus Rhythm and Atrial Contractility Recovery After Radiofrequency Maze in Mitral Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Centro Cardiologico Monzino
Sponsor class: OTHER
First posted: 2014-12-22
Enrollment: 168
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients affected by atrial fibrillation undergoing mitral valve surgery

Brief summary: The present study aimed at evaluating mid-term results of radiofrequency modified maze procedure in mitral patients in terms of sinus rhythm and atrial contractility restoration

Detailed description: Atrial fibrillation presents with different frequencies in patients affected by structural heart diseases requiring surgery, showing a peak incidence of up to 60-80% in mitral subjects. It causes an increased risk of systemic embolism, cardiac failure development and higher limitations due to dyspnoea and fatigue on exercise. Cox-Maze technique for surgical atrial fibrillation treatment was first used in 1987 and suffered lots of modifications since then. Nowadays, most centers have replaced the "cut and sew" technique by other methods using several power sources to achieve the same target in a much easier way. One of the alternative energy source currently used is radiofrequency ablation which has been demonstrated to be a simple, safe and reproducible procedure with an acceptable success rate in terms of sinus rhythm restoration. However, organized atrial activity (sinus rhythm on surface electrocardiogram) is not always accompanied by an effective mechanical atrial contraction, whose restoration represents one of the original Maze objective. Atrial contraction is effective when A waves are found in tricuspid and/or mitral transvalvular flow using Doppler echocardiography, allowing the patient to fully profit from hemodynamic and clinical advantages of an organized atrial contraction. Predictive factors of atrial contractility recovery and, more widely, of sinus rhythm achievement after modified Maze procedures have been investigated, but, at our knowledge, a parallel deep analysis and comparison of possible determinants of both surgical ablation goals is still lacking. In the present study, the investigators describe mid-term results of concomitant modified radiofrequency Maze in a large homogeneous population of mitral patients, focusing onto common predictors of sinus rhythm and atrial contractility restoring, their time course appearance and interrelation.

Eligibility criteria: Inclusion Criteria:

* Patients affected by atrial fibrillation undergoing mitral valve surgery

Exclusion Criteria:

* Other cardiac procedures in addition to mitral valve surgery

Primary outcomes:
measure: Sinus rhythm recovery
timeFrame: 5 years
Secondary outcomes:
measure: Left atrial contractility recovery after maze
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Centro Cardiologico Monzino Milano - Italy
name: Claudia Loardi, MD
role: PRINCIPAL_INVESTIGATOR
References: