NCT00652522

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
3 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 3, 2008

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2017

Completed
Last Updated

February 4, 2019

Status Verified

January 1, 2019

Enrollment Period

9.5 years

First QC Date

March 20, 2008

Last Update Submit

January 31, 2019

Conditions

Persistent Atrial FibrillationHeart FailureICD

Keywords

AF ablationPulmonary vein isolation(PVI)reduced LV ejection fractionsymptomatic atrial fibrillationpersistent AF

Outcome Measures

Primary Outcomes (1)

  • Left ventricular ejection fraction (LVEF) by transthoracic echocardiography (TTE)

    evaluated by Core Lab

    12months

Secondary Outcomes (7)

  • Recurrence of atrial tachyarrhythmia

    9 months

  • Exercise capacity in 6 min walk test

    12 months

  • Quality of life

    12 months

  • AF burden

    9 months

  • Adverse events

    12 months

  • +2 more secondary outcomes

Study Arms (2)

A

ACTIVE COMPARATOR

Best Medical Treatment, ICD/CRT implant

Device: ICD/CRT implantOther: Best Medical Treatment

B

EXPERIMENTAL

AF Ablation, ICD/CRT implant

Device: ICD/CRT implantProcedure: AF ablation

Interventions

ICD/CRT implantDEVICE

Implantation of a ICD/ CRT device if not yet implanted

Also known as: ICDs/ CRT-Ds: All St. Jude Medical device, RA, RV and LV leads: St. Jude Medical CE-marked leads recommended
AB
AF ablationPROCEDURE

Atrial Fibrillation ablation by pulmonary vein isolation

Also known as: Catheters: St. Jude Medical CE-marked catheters recommended, NavX system for 3D mapping
B
Best Medical TreatmentOTHER

Best medical treatment according to current guidelines for Management of Patients with Atrial Fibrillation and for Management of Chronic Heart Failure.

Also known as: Conventional rate or rhythm control according valid guidelines
A

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Herz- und Gefaesszentrum Bad Bevensen

Bad Bevensen, 29549, Germany

Location

Universitäts-Herzzentrum Freiburg - Bad Krozingen

Bad Krozingen, Germany

Location

Kerckhoff-Klinik gGmbH

Bad Nauheim, Germany

Location

Universitätsmedizin Berlin - Charité Campus Virchow-Klinikum (CVK)

Berlin, Germany

Location

Herzzentrum Dresden

Dresden, 01307, Germany

Location

Asklepios Klinik St. Georg

Hamburg, 20099, Germany

Location

Universitäres Herzzentrum Hamburg GmbH / UKE

Hamburg, Germany

Location

Klinikum der Ruprecht-Karls-Universität Heidelberg

Heidelberg, Germany

Location

Klinikum Ingolstadt GmbH

Ingolstadt, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, 04289, Germany

Location

Klinikum der Stadt Ludwigshafen am Rhein gGmbH

Ludwigshafen, Germany

Location

Klinikum Großhadern der Ludwig-Maximilians-Universität

München, Germany

Location

Herzzentrum am Universitätsklinikum Münster

Münster, Germany

Location

St. Adolf-Stift Reinbek

Reinbek, Germany

Location

Semmelweis University

Budapest, Hungary

Location

Hospital Universitari Clinic

Barcelona, Spain

Location

Related Publications (1)

  • 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.

    PMID: 31760819DERIVED

MeSH Terms

Conditions

Atrial FibrillationHeart Failure

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DefibrillatorsElectrodesElectrical Equipment and SuppliesEquipment and SuppliesElectrodes, ImplantedProstheses and Implants

Study Officials

  • Karl-Heinz Kuck, Prof.

    Asklepios Klinik St. Georg - Hamburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2008

First Posted

April 3, 2008

Study Start

January 1, 2008

Primary Completion

July 13, 2017

Study Completion

July 13, 2017

Last Updated

February 4, 2019

Record last verified: 2019-01

Locations

ES(1)DE(14)HU(1)