Status:
COMPLETED
Atrial Fibrillation Management in Congestive Heart Failure With Ablation
Lead Sponsor:
Abbott Medical Devices
Conditions:
Persistent Atrial Fibrillation
Heart Failure
Eligibility:
All Genders
18-75 years
Phase:
NA
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...
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 r...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 13 2017
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT00652522
Start Date
January 1 2008
End Date
July 13 2017
Last Update
February 4 2019
Active Locations (16)
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1
Herz- und Gefaesszentrum Bad Bevensen
Bad Bevensen, Germany, 29549
2
Universitäts-Herzzentrum Freiburg - Bad Krozingen
Bad Krozingen, Germany
3
Kerckhoff-Klinik gGmbH
Bad Nauheim, Germany
4
Universitätsmedizin Berlin - Charité Campus Virchow-Klinikum (CVK)
Berlin, Germany