Atrial Fibrillation Management in Congestive Heart Failure With Ablation
- Conditions
- ICDPersistent Atrial FibrillationHeart Failure
- Interventions
- Device: ICD/CRT implantOther: Best Medical TreatmentProcedure: AF ablation
- Registration Number
- NCT00652522
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
It is the purpose of the study to show the benefit of the endocardial catheter ablation by pulmonary vein isolation in patients with persistent or longstanding persistent atrial fibrillation, low LVEF and requiring ICD or CRT-D therapy compared to the best medical treatment with antiarrhythmic drugs.
- Detailed Description
Atrial fibrillation is the most common sustained cardiac arrhythmia affecting 5% of people older than 65 years. It is associated with a 5 times increase of the risk of stroke in patients who are not receiving anticoagulant therapy and a doubling of the rate of death in all patients.
Congestive heart failure (CHF) and atrial fibrillation (AF) often co-exist, where one condition is promoting the development of the other and worsens its condition.
It is the purpose of the study to show the benefit of the endocardial catheter ablation by pulmonary vein isolation in patients with persistent (for a minimum of 1 week to a maximum of 1 year duration) or longstanding persistent (for a minimum of 1 year to a maximum of 4 years) atrial fibrillation, low LVEF (\<=35%) and requiring ICD or CRT-D therapy compared to the best medical treatment with antiarrhythmic drugs.
Patients meeting the inclusion and exclusion criteria will be randomized in a 1:1 fashion in an unblinded, parallel arm treatment format to either drug therapy (directed at rate or rhythm control) or catheter ablation.
All therapies will be established and optimized in a 3 month treatment initiation phase (Blanking Period) starting with randomization. For all morbidity and mortality end-points, intention-to-treat analysis will begin at randomization. Efficacy with respect to AF treatment will be established for long-term follow up beginning after 3-month initiation phase.
Improvement of LVEF within 12 month is the primary endpoint of this study. The transthoracic echocardiographic (TTE) assessment at enrollment, discharge and 12 months follow-up follows a standardized protocol. The assessments are analyzed, calculated and expressed by an independent Core Lab.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 202
- Having signed and dated Patient Informed Consent
- Having an indication for ICD or CRT-D therapy as indicated by current valid guidelines or having been implanted with an ICD or CRT-D
- Symptomatic atrial fibrillation (persistent AF (for a minimum of 1 week to a maximum of 1 year) or longstanding persistent AF (for a minimum of 1 year to a maximum of 4 years)) irrespective of the duration of paroxysmal AF
- Ejection fraction ≤ 35% as assessed by transthoracic echocardiography
- Left atrial diameter of less than 60 mm in parasternal diameter during transthoracic echocardiographic study
- ECG documentation of atrial fibrillation (ECG, Holter, event recorders, etc) related to symptomatic episodes
- Having typical symptoms of heart failure NYHA II - III
- Patients > 30 days under optimal medical treatment for heart failure and CRT therapy in case of a pre-implanted CRT-D device
- Age 18 - 75 years
- Willing to participate in randomized trial
- Willing and able to participate in 12 months follow-up period
- Longstanding persistent (> 4 years history) or paroxysmal atrial fibrillation
- Having a previously implanted pacemaker
- Having underlying valvular heart disease unless the disease has been corrected
- Patients with acute myocardial infarction
- Patients who have had previous pulmonary vein isolation procedures
- Patients with atrial fibrillation secondary to a reversible cause
- Known presence of intracardiac or other thrombi
- Pregnant females or those of child bearing potential who have not had a negative pregnancy test within 48 hours before treatment
- Patients with other medical condition (i.e., cancer, alcoholism, drug abuse) that may cause the patient to be non-compliant with the protocol, confound the data interpretation or is associated with limited life-expectancy (i.e., less than one year)
- History of bleeding diathesis or suspected pro-coagulant state
- Contraindication to anticoagulation therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Best Medical Treatment Best Medical Treatment, ICD/CRT implant B ICD/CRT implant AF Ablation, ICD/CRT implant A ICD/CRT implant Best Medical Treatment, ICD/CRT implant B AF ablation AF Ablation, ICD/CRT implant
- Primary Outcome Measures
Name Time Method Left ventricular ejection fraction (LVEF) by transthoracic echocardiography (TTE) 12months evaluated by Core Lab
- Secondary Outcome Measures
Name Time Method Number of adequate and inadequate ICD interventions 12 months Exercise capacity in 6 min walk test 12 months AF burden 9 months assessed by ICD/CRT-D device memory in SJM devices
Recurrence of atrial tachyarrhythmia 9 months diagnosed by daily ECG via ECG-recording card
Adverse events 12 months Mortality 12 months Quality of life 12 months assessed by Minnesota Quality of Life Questionnaire
Trial Locations
- Locations (16)
Herz- und Gefaesszentrum Bad Bevensen
🇩🇪Bad Bevensen, Germany
Universitäts-Herzzentrum Freiburg - Bad Krozingen
🇩🇪Bad Krozingen, Germany
Kerckhoff-Klinik gGmbH
🇩🇪Bad Nauheim, Germany
Universitätsmedizin Berlin - Charité Campus Virchow-Klinikum (CVK)
🇩🇪Berlin, Germany
Asklepios Klinik St. Georg
🇩🇪Hamburg, Germany
Universitäres Herzzentrum Hamburg GmbH / UKE
🇩🇪Hamburg, Germany
Klinikum der Ruprecht-Karls-Universität Heidelberg
🇩🇪Heidelberg, Germany
Klinikum Ingolstadt GmbH
🇩🇪Ingolstadt, Germany
Herzzentrum Leipzig GmbH
🇩🇪Leipzig, Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
🇩🇪Ludwigshafen, Germany
St. Adolf-Stift Reinbek
🇩🇪Reinbek, Germany
Herzzentrum am Universitätsklinikum Münster
🇩🇪Münster, Germany
Semmelweis University
🇭🇺Budapest, Hungary
Hospital Universitari Clinic
🇪🇸Barcelona, Spain
Herzzentrum Dresden
🇩🇪Dresden, Germany
Klinikum Großhadern der Ludwig-Maximilians-Universität
🇩🇪München, Germany