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

Heart Failure Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00170313
• Other study ID #: CEN_G_CA_6
• Status: Terminated
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: February 14, 2017
• Start date: December 2003
• Est. completion date: January 2007

Study information

• Verified date: January 2017
• Source: Medtronic Bakken Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Death
• Death, Sudden, Cardiac
• Heart Failure
• Sudden Cardiac Death

Intervention

Device:
• Conducted AF-Response Algorithm (CAFR) On
Algorithm will be enabled.
• Conducted AF-Response Algorithm (CAFR) Off
Algorithm will be disabled.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Aachen	Aachen
Germany	Berufsgenossenschaftliche Kliniken Bergmannsheil	Bochum
Germany	Evangelisches und Johanniter Klinikum Duisburg / Dinslaken / Oberhausen GmbH	Duisburg
Germany	Klinikum der Justus-Liebig-Universität	Gießen
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Marien-Hospital Herne	Herne
Germany	Klinikum Siegburg Rhein-Sieg GmbH Krankenhaus und Herzzentrum Siegburg	Siegburg

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center	Medtronic

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of biventricular pacing in ON-group compared to OFF-group		1 month post-implant to 12 months post-implant
Secondary	Influence of the conducted AF response algorithm on the ventricular heart rate during atrial fibrillation		1 month post-implant to 12 months post-implant
Secondary	Amount of patients who will be free from AF during the study		Implant to 12 months post-implant
Secondary	Amount of hospitalizations due to heart failure (amount and duration in days)		Implant to 12 months post-implant
Secondary	Occurrence and evaluation of rhythm disturbances: atrial arrhythmias (atrial tachyarrhythmia [AT]/AF episodes [h/day])		Implant to 12 months post-implant
Secondary	Occurrence and evaluation of rhythm disturbances: ventricular arrhythmias		Implant to 12 months post-implant
Secondary	Characterization of the heart failure (HF)-patient population by means of: echocardiography [left ventricular ejection fraction (LVEF [%])		Implant to 12 months post-implant
Secondary	Characterization of the heart failure (HF)-patient population by means of: left ventricular end diastolic diameter (LVEDD [mm])		Implant to 12 months post-implant
Secondary	Characterization of the heart failure (HF)-patient population by means of: left ventricular end systolic diameter (LVESD [mm])		Implant to 12 months post-implant
Secondary	Characterization of the heart failure (HF)-patient population by means of: left atrial end diastolic diameter (LAEDD [mm])]		Implant to 12 months post-implant
Secondary	Characterization of the heart failure (HF)-patient population by means of: New York Heart Association (NYHA) classification		Implant to 12 months post-implant
Secondary	Characterization of the heart failure (HF)-patient population by means of: 6-minute walk test		Implant to 12 months post-implant