Atrial Fibrillation Management in Congestive Heart Failure With Ablation

Heart Failure Clinical Trial

— AMICA  

Official title:

Atrial Fibrillation Management in Congestive Heart Failure With Ablation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00652522
• Other study ID #: AF06003AF
• Status: Completed
• Phase: N/A
• Start date: January 2008
• Est. completion date: July 13, 2017

Study information

• Verified date: January 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: July 13, 2017
• Est. primary completion date: July 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure
• ICD
• Persistent Atrial Fibrillation

Intervention

Device:
• ICD/CRT implant
Implantation of a ICD/ CRT device if not yet implanted

Procedure:
• AF ablation
Atrial Fibrillation ablation by pulmonary vein isolation

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.

Locations

Country	Name	City	State
Germany	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
Hungary	Semmelweis University	Budapest
Spain	Hospital Universitari Clinic	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Germany,  Hungary,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular ejection fraction (LVEF) by transthoracic echocardiography (TTE)	evaluated by Core Lab	12months
Secondary	Recurrence of atrial tachyarrhythmia	diagnosed by daily ECG via ECG-recording card	9 months
Secondary	Exercise capacity in 6 min walk test		12 months
Secondary	Quality of life	assessed by Minnesota Quality of Life Questionnaire	12 months
Secondary	AF burden	assessed by ICD/CRT-D device memory in SJM devices	9 months
Secondary	Adverse events		12 months
Secondary	Mortality		12 months
Secondary	Number of adequate and inadequate ICD interventions		12 months