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

Primary Purpose

Persistent Atrial Fibrillation, Heart Failure, ICD

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ICD/CRT implant
AF ablation
Best Medical Treatment
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring AF ablation, Pulmonary vein isolation(PVI), reduced LV ejection fraction, symptomatic atrial fibrillation, persistent AF

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A

B

Arm Description

Best Medical Treatment, ICD/CRT implant

AF Ablation, ICD/CRT implant

Outcomes

Primary Outcome Measures

Left ventricular ejection fraction (LVEF) by transthoracic echocardiography (TTE)
evaluated by Core Lab

Secondary Outcome Measures

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

Full Information

First Posted
March 20, 2008
Last Updated
January 31, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00652522
Brief Title
Atrial Fibrillation Management in Congestive Heart Failure With Ablation
Acronym
AMICA
Official Title
Atrial Fibrillation Management in Congestive Heart Failure With Ablation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 2008 (Actual)
Primary Completion Date
July 13, 2017 (Actual)
Study Completion Date
July 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation, Heart Failure, ICD
Keywords
AF ablation, Pulmonary vein isolation(PVI), reduced LV ejection fraction, symptomatic atrial fibrillation, persistent AF

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Best Medical Treatment, ICD/CRT implant
Arm Title
B
Arm Type
Experimental
Arm Description
AF Ablation, ICD/CRT implant
Intervention Type
Device
Intervention Name(s)
ICD/CRT implant
Other Intervention Name(s)
ICDs/ CRT-Ds: All St. Jude Medical device, RA, RV and LV leads: St. Jude Medical CE-marked leads recommended
Intervention Description
Implantation of a ICD/ CRT device if not yet implanted
Intervention Type
Procedure
Intervention Name(s)
AF ablation
Other Intervention Name(s)
Catheters: St. Jude Medical CE-marked catheters recommended, NavX system for 3D mapping
Intervention Description
Atrial Fibrillation ablation by pulmonary vein isolation
Intervention Type
Other
Intervention Name(s)
Best Medical Treatment
Other Intervention Name(s)
Conventional rate or rhythm control according valid guidelines
Intervention Description
Best medical treatment according to current guidelines for Management of Patients with Atrial Fibrillation and for Management of Chronic Heart Failure.
Primary Outcome Measure Information:
Title
Left ventricular ejection fraction (LVEF) by transthoracic echocardiography (TTE)
Description
evaluated by Core Lab
Time Frame
12months
Secondary Outcome Measure Information:
Title
Recurrence of atrial tachyarrhythmia
Description
diagnosed by daily ECG via ECG-recording card
Time Frame
9 months
Title
Exercise capacity in 6 min walk test
Time Frame
12 months
Title
Quality of life
Description
assessed by Minnesota Quality of Life Questionnaire
Time Frame
12 months
Title
AF burden
Description
assessed by ICD/CRT-D device memory in SJM devices
Time Frame
9 months
Title
Adverse events
Time Frame
12 months
Title
Mortality
Time Frame
12 months
Title
Number of adequate and inadequate ICD interventions
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl-Heinz Kuck, Prof.
Organizational Affiliation
Asklepios Klinik St. Georg - Hamburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herz- und Gefaesszentrum Bad Bevensen
City
Bad Bevensen
ZIP/Postal Code
29549
Country
Germany
Facility Name
Universitäts-Herzzentrum Freiburg - Bad Krozingen
City
Bad Krozingen
Country
Germany
Facility Name
Kerckhoff-Klinik gGmbH
City
Bad Nauheim
Country
Germany
Facility Name
Universitätsmedizin Berlin - Charité Campus Virchow-Klinikum (CVK)
City
Berlin
Country
Germany
Facility Name
Herzzentrum Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Asklepios Klinik St. Georg
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Universitäres Herzzentrum Hamburg GmbH / UKE
City
Hamburg
Country
Germany
Facility Name
Klinikum der Ruprecht-Karls-Universität Heidelberg
City
Heidelberg
Country
Germany
Facility Name
Klinikum Ingolstadt GmbH
City
Ingolstadt
Country
Germany
Facility Name
Herzzentrum Leipzig GmbH
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
City
Ludwigshafen
Country
Germany
Facility Name
Klinikum Großhadern der Ludwig-Maximilians-Universität
City
München
Country
Germany
Facility Name
Herzzentrum am Universitätsklinikum Münster
City
Münster
Country
Germany
Facility Name
St. Adolf-Stift Reinbek
City
Reinbek
Country
Germany
Facility Name
Semmelweis University
City
Budapest
Country
Hungary
Facility Name
Hospital Universitari Clinic
City
Barcelona
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
31760819
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.
Results Reference
derived

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Atrial Fibrillation Management in Congestive Heart Failure With Ablation

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