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AMICA: Atrial Fibrillation Management in Congestive Heart Failure With Ablation

Sponsor
Abbott Medical Devices (Industry)
Overall Status
Completed
CT.gov ID
NCT00652522
Collaborator
(none)
202
Enrollment
16
Locations
2
Arms
114.4
Actual Duration (Months)
12.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: ICD/CRT implant
  • Procedure: AF ablation
  • Other: Best Medical Treatment
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
202 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Atrial Fibrillation Management in Congestive Heart Failure With Ablation
Actual Study Start Date :
Jan 1, 2008
Actual Primary Completion Date :
Jul 13, 2017
Actual Study Completion Date :
Jul 13, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Left ventricular ejection fraction (LVEF) by transthoracic echocardiography (TTE) [12months]

      evaluated by Core Lab

    Secondary Outcome Measures

    1. Recurrence of atrial tachyarrhythmia [9 months]

      diagnosed by daily ECG via ECG-recording card

    2. Exercise capacity in 6 min walk test [12 months]

    3. Quality of life [12 months]

      assessed by Minnesota Quality of Life Questionnaire

    4. AF burden [9 months]

      assessed by ICD/CRT-D device memory in SJM devices

    5. Adverse events [12 months]

    6. Mortality [12 months]

    7. Number of adequate and inadequate ICD interventions [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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
    5 Herzzentrum Dresden Dresden Germany 01307
    6 Asklepios Klinik St. Georg Hamburg Germany 20099
    7 Universitäres Herzzentrum Hamburg GmbH / UKE Hamburg Germany
    8 Klinikum der Ruprecht-Karls-Universität Heidelberg Heidelberg Germany
    9 Klinikum Ingolstadt GmbH Ingolstadt Germany
    10 Herzzentrum Leipzig GmbH Leipzig Germany 04289
    11 Klinikum der Stadt Ludwigshafen am Rhein gGmbH Ludwigshafen Germany
    12 Klinikum Großhadern der Ludwig-Maximilians-Universität München Germany
    13 Herzzentrum am Universitätsklinikum Münster Münster Germany
    14 St. Adolf-Stift Reinbek Reinbek Germany
    15 Semmelweis University Budapest Hungary
    16 Hospital Universitari Clinic Barcelona Spain

    Sponsors and Collaborators

    • Abbott Medical Devices

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abbott Medical Devices
    ClinicalTrials.gov Identifier:
    NCT00652522
    Other Study ID Numbers:
    • AF06003AF
    First Posted:
    Apr 3, 2008
    Last Update Posted:
    Feb 4, 2019
    Last Verified:
    Jan 1, 2019
    Keywords provided by Abbott Medical Devices
    AF ablation
    Pulmonary vein isolation(PVI)
    reduced LV ejection fraction
    symptomatic atrial fibrillation
    persistent AF
    Additional relevant MeSH terms:
    Heart Failure
    Atrial Fibrillation

    Study Results

    No Results Posted as of Feb 4, 2019