Atrial Fibrillation Management in Congestive Heart Failure With Ablation (AMICA)

January 31, 2019 updated by: Abbott Medical Devices
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Bevensen, Germany, 29549
        • Herz- und Gefaesszentrum Bad Bevensen
      • Bad Krozingen, Germany
        • Universitäts-Herzzentrum Freiburg - Bad Krozingen
      • Bad Nauheim, Germany
        • Kerckhoff-Klinik gGmbH
      • Berlin, Germany
        • Universitätsmedizin Berlin - Charité Campus Virchow-Klinikum (CVK)
      • Dresden, Germany, 01307
        • Herzzentrum Dresden
      • Hamburg, Germany, 20099
        • Asklepios Klinik St. Georg
      • Hamburg, Germany
        • Universitäres Herzzentrum Hamburg GmbH / UKE
      • Heidelberg, Germany
        • Klinikum der Ruprecht-Karls-Universität Heidelberg
      • Ingolstadt, Germany
        • Klinikum Ingolstadt GmbH
      • Leipzig, Germany, 04289
        • Herzzentrum Leipzig GmbH
      • Ludwigshafen, Germany
        • Klinikum der Stadt Ludwigshafen am Rhein gGmbH
      • München, Germany
        • Klinikum Großhadern der Ludwig-Maximilians-Universität
      • Münster, Germany
        • Herzzentrum am Universitätsklinikum Münster
      • Reinbek, Germany
        • St. Adolf-Stift Reinbek
  • Hungary
      • Budapest, Hungary
        • Semmelweis University
  • Spain
      • Barcelona, Spain
        • Hospital Universitari Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Best Medical Treatment, ICD/CRT implant
Device: ICD/CRT implant
Implantation of a ICD/ CRT device if not yet implanted
Other Names:
  • ICDs/ CRT-Ds: All St. Jude Medical device
  • RA, RV and LV leads: St. Jude Medical CE-marked leads recommended
Other: Best Medical Treatment
Best medical treatment according to current guidelines for Management of Patients with Atrial Fibrillation and for Management of Chronic Heart Failure.
Other Names:
  • Conventional rate or rhythm control according valid guidelines
Experimental: B
AF Ablation, ICD/CRT implant
Device: ICD/CRT implant
Implantation of a ICD/ CRT device if not yet implanted
Other Names:
  • ICDs/ CRT-Ds: All St. Jude Medical device
  • RA, RV and LV leads: St. Jude Medical CE-marked leads recommended
Procedure: AF ablation
Atrial Fibrillation ablation by pulmonary vein isolation
Other Names:
  • Catheters: St. Jude Medical CE-marked catheters recommended
  • NavX system for 3D mapping

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left ventricular ejection fraction (LVEF) by transthoracic echocardiography (TTE)
Time Frame: 12months
evaluated by Core Lab
12months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 12 months
12 months
Adverse events
Time Frame: 12 months
12 months
Recurrence of atrial tachyarrhythmia
Time Frame: 9 months
diagnosed by daily ECG via ECG-recording card
9 months
Exercise capacity in 6 min walk test
Time Frame: 12 months
12 months
Quality of life
Time Frame: 12 months
assessed by Minnesota Quality of Life Questionnaire
12 months
AF burden
Time Frame: 9 months
assessed by ICD/CRT-D device memory in SJM devices
9 months
Number of adequate and inadequate ICD interventions
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Karl-Heinz Kuck, Prof., Asklepios Klinik St. Georg - Hamburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2008

Primary Completion (Actual)

July 13, 2017

Study Completion (Actual)

July 13, 2017

Study Registration Dates

First Submitted

March 20, 2008

First Submitted That Met QC Criteria

March 31, 2008

First Posted (Estimate)

April 3, 2008

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AF06003AF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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