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Follow up of Radiofrequency Maze in Mitral Patients

NCT02321020 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 168

Last updated 2014-12-22

No results posted yet for this study

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Centro Cardiologico Monzino

    lead OTHER

Principal Investigators

  • Claudia Loardi, MD · Centro Cardiologico Monzino Milano - Italy

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-01-31
Primary Completion
2014-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02321020 on ClinicalTrials.gov