Clinical trial NCT00652522: Atrial Fibrillation Management in Congestive Heart Failure With Ablation
Official title: Atrial Fibrillation Management in Congestive Heart Failure With Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Atrial Fibrillation
Heart Failure
ICD
Keywords: AF ablation
Pulmonary vein isolation(PVI)
reduced LV ejection fraction
symptomatic atrial fibrillation
persistent AF
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2008-04-03
Enrollment: 202
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: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Left ventricular ejection fraction (LVEF) by transthoracic echocardiography (TTE)
timeFrame: 12months
Secondary outcomes:
measure: Recurrence of atrial tachyarrhythmia
timeFrame: 9 months
measure: Exercise capacity in 6 min walk test
timeFrame: 12 months
measure: Quality of life
timeFrame: 12 months
measure: AF burden
timeFrame: 9 months
measure: Adverse events
timeFrame: 12 months
measure: Mortality
timeFrame: 12 months
measure: Number of adequate and inadequate ICD interventions
timeFrame: 12 months
Other outcomes:
Locations:
city: Bad Bevensen
country: Germany
facility: Herz- und Gefaesszentrum Bad Bevensen
city: Bad Krozingen
country: Germany
facility: Universitäts-Herzzentrum Freiburg - Bad Krozingen
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik gGmbH
city: Berlin
country: Germany
facility: Universitätsmedizin Berlin - Charité Campus Virchow-Klinikum (CVK)
city: Dresden
country: Germany
facility: Herzzentrum Dresden
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Hamburg
country: Germany
facility: Universitäres Herzzentrum Hamburg GmbH / UKE
city: Heidelberg
country: Germany
facility: Klinikum der Ruprecht-Karls-Universität Heidelberg
city: Ingolstadt
country: Germany
facility: Klinikum Ingolstadt GmbH
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH
city: München
country: Germany
facility: Klinikum Großhadern der Ludwig-Maximilians-Universität
city: Münster
country: Germany
facility: Herzzentrum am Universitätsklinikum Münster
city: Reinbek
country: Germany
facility: St. Adolf-Stift Reinbek
city: Budapest
country: Hungary
facility: Semmelweis University
city: Barcelona
country: Spain
facility: Hospital Universitari Clinic
Study officials:
affiliation: Asklepios Klinik St. Georg - Hamburg
name: Karl-Heinz Kuck, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kuck KH, Merkely B, Zahn R, Arentz T, Seidl K, Schluter M, Tilz RR, Piorkowski C, Geller L, Kleemann T, Hindricks G. Catheter Ablation Versus Best Medical Therapy in Patients With Persistent Atrial Fibrillation and Congestive Heart Failure: The Randomized AMICA Trial. Circ Arrhythm Electrophysiol. 2019 Dec;12(12):e007731. doi: 10.1161/CIRCEP.119.007731. Epub 2019 Nov 25.