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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00652522
First received: March 20, 2008
Last updated: March 23, 2014
Last verified: March 2014
  Purpose

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 Intervention
Persistent Atrial Fibrillation
Heart Failure
ICD
Device: ICD/CRT implant
Procedure: AF ablation
Other: Best Medical Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Atrial Fibrillation Management in Congestive Heart Failure With Ablation

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Left ventricular ejection fraction (LVEF) by transthoracic echocardiography (TTE) [ Time Frame: 12months ] [ Designated as safety issue: Yes ]
    evaluated by Core Lab


Secondary Outcome Measures:
  • Recurrence of atrial tachyarrhythmia [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    diagnosed by daily ECG via ECG-recording card

  • Exercise capacity in 6 min walk test [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    assessed by Minnesota Quality of Life Questionnaire

  • AF burden [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    assessed by ICD/CRT-D device memory in SJM devices

  • Adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Mortality [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Number of adequate and inadequate ICD interventions [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 216
Study Start Date: January 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652522

Contacts
Contact: Hindrik Robbe, PhD +3227746849 hrobbe@sjm.com

Locations
Germany
Universitäts-Herzzentrum Freiburg - Bad Krozingen Recruiting
Bad Krozingen, Germany
Principal Investigator: Thomas Arentz, Prof.         
Kerckhoff-Klinik gGmbH Recruiting
Bad Nauheim, Germany
Principal Investigator: Johannes Sperzel, MD         
Principal Investigator: Malte Kuniss, MD         
Universitätsmedizin Berlin - Charité Campus Virchow-Klinikum (CVK) Recruiting
Berlin, Germany
Principal Investigator: Leif-Hendrik Boldt, MD         
Elisabeth-Krankenhaus Essen GmbH Not yet recruiting
Essen, Germany
Principal Investigator: Anja Dorszewski, MD         
Asklepios Klinik St. Georg Recruiting
Hamburg, Germany, 20099
Contact: Karl-Heinz Kuck, Prof.    +49 40 1818 85 ext 2305    k.kuck@asklepios.com   
Principal Investigator: Karl-Heinz Kuck, Prof.         
Universitäres Herzzentrum Hamburg GmbH / UKE Recruiting
Hamburg, Germany
Principal Investigator: Stephan Willems, Prof.         
Klinikum der Ruprecht-Karls-Universität Heidelberg Recruiting
Heidelberg, Germany
Principal Investigator: Rüdiger Becker, Prof.         
Klinikum Ingolstadt GmbH Recruiting
Ingolstadt, Germany
Principal Investigator: Karlheinz Seidl, Prof.         
Herzzentrum Leipzig GmbH Recruiting
Leipzig, Germany, 04289
Contact: Gerhard Hindricks, Prof.         
Principal Investigator: Gerhard Hindricks, Prof.         
Klinikum der Stadt Ludwigshafen am Rhein gGmbH Recruiting
Ludwigshafen, Germany
Contact: Thomas Kleemann, MD         
Principal Investigator: Ralf Zahn, Prof.         
Städtisches Klinikum Lüneburg gGmbH Active, not recruiting
Lüneburg, Germany
Maria-Hilf Franziskus-Krankenhaus Active, not recruiting
Mönchengladbach, Germany
Klinikum Großhadern der Ludwig-Maximilians-Universität Recruiting
München, Germany
Principal Investigator: Stefan Kääb, Prof.         
Herzzentrum am Universitätsklinikum Münster Recruiting
Münster, Germany
Principal Investigator: Lars Eckhardt, Pro.         
St. Adolf-Stift Reinbek Recruiting
Reinbek, Germany
Principal Investigator: Herbert Nägele, Prof.         
Hungary
Semmelweis University Recruiting
Budapest, Hungary
Contact: Belá Merkely, Prof.         
Principal Investigator: Belá Merkely, Prof.         
Spain
Hospital Universitari Clinic Terminated
Barcelona, Spain
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Karl-Heinz Kuck, Prof. Asklepios Klinik St. Georg - Hamburg
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00652522     History of Changes
Other Study ID Numbers: AF06003AF
Study First Received: March 20, 2008
Last Updated: March 23, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by St. Jude Medical:
AF ablation
Pulmonary vein isolation(PVI)
reduced LV ejection fraction
symptomatic atrial fibrillation
persistent AF

Additional relevant MeSH terms:
Atrial Fibrillation
Heart Failure
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014