Atrial Fibrillation Management in Congestive Heart Failure With Ablation

NCT ID: NCT00652522

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2017-07-13

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.

Conditions

Persistent Atrial Fibrillation; Heart Failure; ICD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Best Medical Treatment, ICD/CRT implant

Group Type: ACTIVE_COMPARATOR

ICD/CRT implant

Intervention Type: DEVICE

Implantation of a ICD/ CRT device if not yet implanted

Best Medical Treatment

Intervention Type: OTHER

Best medical treatment according to current guidelines for Management of Patients with Atrial Fibrillation and for Management of Chronic Heart Failure.

B

AF Ablation, ICD/CRT implant

Group Type: EXPERIMENTAL

ICD/CRT implant

Intervention Type: DEVICE

Implantation of a ICD/ CRT device if not yet implanted

AF ablation

Intervention Type: PROCEDURE

Atrial Fibrillation ablation by pulmonary vein isolation

Interventions

ICD/CRT implant

Implantation of a ICD/ CRT device if not yet implanted

Intervention Type: DEVICE

AF ablation

Atrial Fibrillation ablation by pulmonary vein isolation

Intervention Type: PROCEDURE

Best Medical Treatment

Best medical treatment according to current guidelines for Management of Patients with Atrial Fibrillation and for Management of Chronic Heart Failure.

Intervention Type: OTHER

Other Intervention Names

ICDs/ CRT-Ds: All St. Jude Medical device; RA, RV and LV leads: St. Jude Medical CE-marked leads recommended; Catheters: St. Jude Medical CE-marked catheters recommended; NavX system for 3D mapping; Conventional rate or rhythm control according valid guidelines

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karl-Heinz Kuck, Prof.

Role: PRINCIPAL_INVESTIGATOR

Asklepios Klinik St. Georg - Hamburg

Locations

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

Herzzentrum Dresden

Dresden, , 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

Klinikum Großhadern der Ludwig-Maximilians-Universität

München, , Germany

Herzzentrum am Universitätsklinikum Münster

Münster, , Germany

St. Adolf-Stift Reinbek

Reinbek, , Germany

Semmelweis University

Budapest, , Hungary

Hospital Universitari Clinic

Barcelona, , Spain

Countries

Germany; Hungary; Spain

References

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.

Reference Type: DERIVED

PMID: 31760819 (View on PubMed)

Other Identifiers

AF06003AF

Identifier Type: -

Identifier Source: org_study_id