Follow up of Radiofrequency Maze in Mitral Patients
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|ClinicalTrials.gov Identifier: NCT02321020|
Recruitment Status : Completed
First Posted : December 22, 2014
Last Update Posted : December 22, 2014
|Condition or disease||Intervention/treatment|
|Atrial Fibrillation||Procedure: Radiofrequency maze procedure Procedure: Transthoracic echocardiography|
|Study Type :||Observational|
|Actual Enrollment :||168 participants|
|Official Title:||Sinus Rhythm and Atrial Contractility Recovery After Radiofrequency Maze in Mitral Patients|
|Study Start Date :||January 2002|
|Actual Primary Completion Date :||December 2014|
- Procedure: Radiofrequency maze procedure
Radiofrequency 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 the first 70 patients a monopolar technology was employed (Cardioblate Surgical Ablation Pen, Medtronic Inc, Minneapolis, MN, USA - cooled tip cardioblate pen, power ranging from 25 to 35 W), while in the subset of patients who underwent surgery after July 2005 a bipolar device was used (Cardioblate BP2 Irrigated RF Surgical Ablation System, Medtronic Inc, Minneapolis, MN, USA). The tip of both types of RF probe was irrigated with saline at room temperature at a flow rate of 4-6 ml/min.
- Procedure: Transthoracic echocardiography
Contemporary to clinical follow up, all patients were evaluated with 2-dimensional transthoracic echocardiography by the same cardiologist at 3,6,12 and 24 months in order to specifically monitor left atrial contractility presence.
- Sinus rhythm recovery [ Time Frame: 5 years ]Early postoperative rhythms were checked in all patients daily by standard 12-channel surface electrocardiogram. Follow up 24 hours Holter monitoring was checked postoperatively at 3,6,12 and 24 months after the intervention and then annually.
- Left atrial contractility recovery after maze [ Time Frame: 24 months ]All patients were evaluated with 2-dimensional transthoracic echocardiography by the same cardiologist at 3,6,12 and 24 months in order to specifically monitor left 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. Atrial mechanical activity was considered present if an atrial filling (A wave) was detected in late diastole after the electrocardiogram P wave.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02321020
|Principal Investigator:||Claudia Loardi, MD||Centro Cardiologico Monzino Milano - Italy|