Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| PF 178 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Profileringsfonds Maastricht | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Atrial fibrillation (AF) is connected with an increased morbidity and mortality. In addition, quality of life is diminished due to palpitations, dyspnea, dizziness and syncope. AF is frequently associated with valvular and coronary disease. In the AF patients undergoing valvular or coronary surgery the arrhythmia almost always relapses. For symptom control anti-arrhythmic drugs and cardioversion are used but breakthrough arrhythmias and side effects of the drugs happen frequently. For more effective symptom control "add-on" arrhythmia surgery is being advocated. However, at present the investigators do not know whether add-on arrhythmia surgery indeed affects morbidity and quality of life.
The hypothesis being studied is that add-on arrhythmia surgery in patients with AF undergoing valvular or coronary surgery improves quality of life, establishes chronic sinus rhythm and reduces perioperative and long-term morbidity associated with AF.
Multicentre prospective parallel randomised controlled trial. In total 150 patients with documented atrial fibrillation (chronic and paroxysmal), were randomly assigned by a central computer system to undergo cardiac surgery with add-on surgery or without. This assignment was blinded to patients and all medical personnel except for the surgical team during total follow up. Patients completed quality of life questionnaires, comprising the RAND 36-item Health Survey 1.0 (SF-36), Multidimensional Fatigue Inventory-20 (MFI-20) and EuroQoL (EQ-5D and VAS) at baseline and 3, 6 and 12 months following operation.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Add-on arrhythmia surgery | Experimental | Adjuvant anti-arrhythmic surgery consists of a beating heart epicardial "box" isolation of all pulmonary veins using microwave energy (Flex 4 or Flex 10 ablation probes and Microwave generator by Guidant/Afix, Fremont, CA, USA). The surgical ablation procedure is the first step during surgery and is performed before institution of cardiopulmonary bypass allowing off-pump beating heart ablation. In addition excision or exclusion of the left atrial appendage is performed in both the treated as the control group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary vein isolation using microwave energy | Procedure | The surgical ablation procedure is the first step during surgery and is performed before institution of cardiopulmonary bypass allowing off-pump beating heart ablation. The off-pump beating heart ablation procedure is performed according to a specific box lesion surrounding the pulmonary veins, using microwave energy. Afterwards cardiac surgery is performed as usual in both treatment arms. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life and maintenance of sinus rhythm at 1 year will be considered as primary end points. | Baseline, 3, 6, and 12 months after operation |
| Measure | Description | Time Frame |
|---|---|---|
| In-hospital and out-of-hospital morbidity and mortality during one year follow-up | Baseline, 1, 6 and 12 months after operation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jos G. Maessen, PhD | Maastricht University Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Cardiothoracic Surgery, University Hospital Maastricht | Maastricht | 6202 AZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19925605 | Derived | Van Breugel HN, Nieman FH, Accord RE, Van Mastrigt GA, Nijs JF, Severens JL, Vrakking R, Maessen JG. A prospective randomized multicenter comparison on health-related quality of life: the value of add-on arrhythmia surgery in patients with paroxysmal, permanent or persistent atrial fibrillation undergoing valvular and/or coronary bypass surgery. J Cardiovasc Electrophysiol. 2010 May;21(5):511-20. doi: 10.1111/j.1540-8167.2009.01655.x. Epub 2009 Nov 17. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |