CORE: Study to Evaluate the Conducted AF-Response-Algorithm in Patients Suffering From Heart Failure and Atrial Fibrillation - Full Text View

Sponsors and Collaborators:	Medtronic Bakken Research Center Medtronic
Information provided by:	Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:	NCT00170313

Purpose

The Medtronic InSync III Marquis Cardiac Resynchronization Therapy Defibrillator (CRT-D)-System (implantable cardioverter-defibrillator with biventricular stimulation for cardiac resynchronization) is equipped with the "Conducted-Atrial Fibrillation (AF)-Response-Algorithm (CAFR)". This algorithm is designed to maximize biventricular stimulation and thus the amount of cardiac resynchronization when atrial fibrillation occurs. The goal of the study is the evaluation of the effect of the CAFR in CRT-patients suffering from atrial fibrillation by quantification of the increase of biventricular pacing during atrial fibrillation caused by CAFR as well as the influence of the CAFR on the ventricular heart rate.

Condition	Intervention	Phase
Heart Failure Sudden Cardiac Death Atrial Fibrillation	Device: Conducted AF-Response Algorithm	Phase IV

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Cardiac Arrest Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Conducted AF-Response Study (Study to Evaluate the Conducted AF-Response-Algorithm in Patients Suffering From Heart Failure and Atrial Fibrillation Treated With InSync III Marquis)

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:

Amount of biventricular pacing in ON-group compared to OFF-group

Secondary Outcome Measures:

Influence of the conducted AF response algorithm on the ventricular heart rate during atrial fibrillation
Amount of patients who will be free from AF during the study
Amount of hospitalizations due to heart failure (amount and duration in days)
Occurrence and evaluation of rhythm disturbances: atrial arrhythmias (atrial tachyarrhythmia [AT]/AF episodes [h/day])
ventricular arrhythmias
Characterization of the heart failure (HF)-patient population by means of: echocardiography [left ventricular ejection fraction (LVEF [%])
left ventricular end diastolic diameter (LVEDD [mm])
left ventricular end systolic diameter (LVESD [mm])
left atrial end diastolic diameter (LAEDD [mm])]
New York Heart Association (NYHA) classification
6-minute walk test

Estimated Enrollment:	100
Study Start Date:	December 2003
Study Completion Date:	January 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Implant of a Medtronic InSync III Marquis (7279) or later system with Conducted AF-Response

Exclusion Criteria:

Medical reasons that are adverse to participation in the study and compliance by the patient
Patients who are enrolled in another study or plan to be enrolled into another study
Pregnant patients or patients who are possibly pregnant due to an unreliable form of contraception

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00170313

Locations

Germany
Marien-Hospital Herne
Herne, Germany, 44625
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Klinikum der Justus-Liebig-Universität
Gießen, Germany, 35385
Universitätsklinikum Aachen
Aachen, Germany, 52066
Klinikum Siegburg Rhein-Sieg GmbH Krankenhaus und Herzzentrum Siegburg
Siegburg, Germany, 53721
Evangelisches und Johanniter Klinikum Duisburg / Dinslaken / Oberhausen GmbH
Duisburg, Germany, 47137
Berufsgenossenschaftliche Kliniken Bergmannsheil
Bochum, Germany, 44789

Sponsors and Collaborators

Medtronic Bakken Research Center

Medtronic

Investigators

Principal Investigator:

Christian Perings, MD

Marien-Hospital Herne

More Information

Study ID Numbers:	CEN_G_CA_6
Study First Received:	September 13, 2005
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00170313
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Medtronic Bakken Research Center:

Heart Failure
Primary Prevention of Sudden Cardiac Death
Secondary Prevention of Sudden Cardiac Death

Cardiac Desynchronization
CRT-D
Cardiac Dyssynchrony

Study placed in the following topic categories:

Death
Heart Failure
Heart Diseases
Death, Sudden
Neoplasm Metastasis

Heart Arrest
Atrial Fibrillation
Death, Sudden, Cardiac
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009