Clinical trial NCT00170313: CORE: Study to Evaluate the Conducted AF-Response-Algorithm in Patients Suffering From Heart Failure and Atrial Fibrillation
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Heart Failure
Sudden Cardiac Death
Atrial Fibrillation
Keywords: Heart Failure
Primary Prevention of Sudden Cardiac Death
Secondary Prevention of Sudden Cardiac Death
Cardiac Desynchronization
CRT-D
Cardiac Dyssynchrony
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2005-09-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Amount of biventricular pacing in ON-group compared to OFF-group
timeFrame: 1 month post-implant to 12 months post-implant
Secondary outcomes:
measure: Influence of the conducted AF response algorithm on the ventricular heart rate during atrial fibrillation
timeFrame: 1 month post-implant to 12 months post-implant
measure: Amount of patients who will be free from AF during the study
timeFrame: Implant to 12 months post-implant
measure: Amount of hospitalizations due to heart failure (amount and duration in days)
timeFrame: Implant to 12 months post-implant
measure: Occurrence and evaluation of rhythm disturbances: atrial arrhythmias (atrial tachyarrhythmia [AT]/AF episodes [h/day])
timeFrame: Implant to 12 months post-implant
measure: Occurrence and evaluation of rhythm disturbances: ventricular arrhythmias
timeFrame: Implant to 12 months post-implant
measure: Characterization of the heart failure (HF)-patient population by means of: echocardiography [left ventricular ejection fraction (LVEF [%])
timeFrame: Implant to 12 months post-implant
measure: Characterization of the heart failure (HF)-patient population by means of: left ventricular end diastolic diameter (LVEDD [mm])
timeFrame: Implant to 12 months post-implant
measure: Characterization of the heart failure (HF)-patient population by means of: left ventricular end systolic diameter (LVESD [mm])
timeFrame: Implant to 12 months post-implant
measure: Characterization of the heart failure (HF)-patient population by means of: left atrial end diastolic diameter (LAEDD [mm])]
timeFrame: Implant to 12 months post-implant
measure: Characterization of the heart failure (HF)-patient population by means of: New York Heart Association (NYHA) classification
timeFrame: Implant to 12 months post-implant
measure: Characterization of the heart failure (HF)-patient population by means of: 6-minute walk test
timeFrame: Implant to 12 months post-implant
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
city: Bochum
country: Germany
facility: Berufsgenossenschaftliche Kliniken Bergmannsheil
city: Duisburg
country: Germany
facility: Evangelisches und Johanniter Klinikum Duisburg / Dinslaken / Oberhausen GmbH
city: Gießen
country: Germany
facility: Klinikum der Justus-Liebig-Universität
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Herne
country: Germany
facility: Marien-Hospital Herne
city: Siegburg
country: Germany
facility: Klinikum Siegburg Rhein-Sieg GmbH Krankenhaus und Herzzentrum Siegburg
Study officials:
affiliation: Marien-Hospital Herne
name: Christian Perings, MD
role: PRINCIPAL_INVESTIGATOR
References: