Trials / Completed
CompletedNCT02303652
Biatrial Contractility Recovery After Maze
Surgical Treatment of Concomitant Atrial Fibrillation: a Comprehensive Insight Into Biatrial Contractility Recovery.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 122 (actual)
- Sponsor
- Centro Cardiologico Monzino · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This study aimed at evaluating multiple aspects of biatrial contractility recovery after modified maze procedure during mitral valve surgery.
Detailed description
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | 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). |
| 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. |
Timeline
- Start date
- 2005-01-01
- Primary completion
- 2014-11-01
- First posted
- 2014-12-01
- Last updated
- 2014-12-01
Source: ClinicalTrials.gov record NCT02303652. Inclusion in this directory is not an endorsement.