Biatrial Contractility Recovery After Maze

Atrial Fibrillation Clinical Trial

Official title:

Surgical Treatment of Concomitant Atrial Fibrillation: a Comprehensive Insight Into Biatrial Contractility Recovery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02303652
• Other study ID #: ACFA1
• Status: Completed
• Phase: N/A
• First received: November 24, 2014
• Last updated: November 25, 2014
• Start date: January 2005

Study information

• Verified date: November 2014
• Source: Centro Cardiologico Monzino
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients affected by atrial fibrillation undergoing mitral valve surgery

Exclusion Criteria:

• Other cardiac procedures in addition to mitral valve surgery

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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).
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centro Cardiologico Monzino

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biatrial contractility recovery after maze	All patients were evaluated with 2-dimensional transthoracic echocardiography 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.; Transmitral flow velocity was measured with pulsed Doppler echocardiography, with a sample volume positioned at the level of the mitral tip in the apical four-chamber view and was recorded on a strip chart at a paper speed of 100 mm/s. Peak velocity and the time-velocity integral of the early filling wave (E wave) and of the late filling wave (A wave) were determined. A/E ratio, representing atrial contribution to ventricular diastolic filling, was obtained. Each measurement was obtained as an average of 6 to 8 consecutive beats.	24 months	No