Clinical trial NCT00157807: Clinical and Economic Consequences of Left Atrial Bipolar Radiofrequency Ablation of Persistent and Permanent Atrial Fibrillation During Cardiac Surgery
Official title: Clinical and Economic Consequences of Left Atrial Bipolar Radiofrequency Ablation of Persistent and Permanent Atrial Fibrillation During Cardiac Surgery. A Prospective Randomized Multi Center Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Coronary Artery Disease
Keywords: Persistent Atrial Fibrillation
Permanent Atrial Fibrillation
Mitral Valve Defect
Tricuspid Valve Defect
Aortic Valve Defect
Lead sponsor: Medtronic Cardiac Surgery
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2005-09-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The clinical effects of intra-operative radiofrequency ablation in patients with persistent or permanent atrial fibrillation and an indication for an implantation of a heart valve prosthesis or coronary bypass surgery are the purposes of this study. The study will examine if and to what extent the quality of life and the use of medical care differs between patients with and without ablation. Furthermore, there will be thorough echocardiographic examinations of the heart to detect differences between the different treatment groups. The patients will be followed for one year after treatment.


Eligibility criteria: Inclusion Criteria:

* Persistent atrial fibrillation
* Permanent atrial fibrillation
* Mitral valve defect
* Tricuspid valve defect
* Aortic valve defect
* Coronary artery disease

Exclusion Criteria:

* Pregnancy
* Age \< 18 or \> 75 Years
* Emergency surgery
* Left dominant coronary circulation (relative contraindication)
* Coronary arteries of the posterior wall without pathological findings: No inclusion
* Stenosis of the posterior wall vessels, supplied with a CABG (coronary artery bypass grafting): Inclusion possible
* Left ventricular ejection fraction \< 30%
* Size of the left atrium \> 7 cm
* Thrombosis of the left atrial appendage
* Leads in the coronary sinus
* Atrial flutter
* Infective endocarditis
* Reoperation
* Participation in other studies
* Life expectancy of less than 12 months
* Psychiatric disorders
* Hyperthyreosis

Primary outcomes:
measure: Quality of life
timeFrame: 12 months
measure: Cost of care
timeFrame: 12 months
Secondary outcomes:
measure: Atrial fibrillation
timeFrame: 12 months
measure: Echo parameters
timeFrame: 12 months
Other outcomes:
Locations:
city: Lahr
country: Germany
facility: Klinik für Herz-, Thorax- und Gefäßchirurgie
state: Baden Württemberg
city: München
country: Germany
facility: Klinikum der Universität Muenchen Großhadern Cardiac Surgery
state: Bayern
city: Bochum
country: Germany
facility: Klinik für Herz- und Thoraxchirurgie
state: Nordrhein-Westfalen
city: Bonn
country: Germany
facility: Klinik und Poliklinik für Herzchirurgie der Rhein. Friedrich-Wilhelms-Universität Bonn
state: Nordrhein-Westfalen
city: Halle
country: Germany
facility: Klinik für Herz- und Thoraxchirurgie der Martin-Luther-Universität Halle-Wittenberg
state: Sachsen
Study officials:
affiliation: Klinikum der Universität München Großhadern Cardiac Surgery
name: Calin Vicol, Professor
role: PRINCIPAL_INVESTIGATOR
References: