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

NCT00170313 | Terminated Phase 4

• 1 other identifier: CEN_G_CA_6
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 7

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.

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

Outcome Measures

Primary Outcomes (1)

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

  1 month post-implant to 12 months post-implant

Secondary Outcomes (11)

• Influence of the conducted AF response algorithm on the ventricular heart rate during atrial fibrillation

  1 month post-implant to 12 months post-implant

• Amount of patients who will be free from AF during the study

  Implant to 12 months post-implant

• Amount of hospitalizations due to heart failure (amount and duration in days)

  Implant to 12 months post-implant

• Occurrence and evaluation of rhythm disturbances: atrial arrhythmias (atrial tachyarrhythmia [AT]/AF episodes [h/day])

  Implant to 12 months post-implant

• Occurrence and evaluation of rhythm disturbances: ventricular arrhythmias

  Implant to 12 months post-implant

Study Arms (2)

Conducted AF-Response Algorithm (CAFR) On

EXPERIMENTAL

CAFR: On * Level medium * Max. Rate: 110ppm VSR: Off

Device: Conducted AF-Response Algorithm (CAFR) On

Conducted AF-Response Algorithm (CAFR) Off

ACTIVE COMPARATOR

CAFR: Off VSR: Off

Device: Conducted AF-Response Algorithm (CAFR) Off

Interventions

Conducted AF-Response Algorithm (CAFR) On DEVICE

Algorithm will be enabled.

Conducted AF-Response Algorithm (CAFR) On

Conducted AF-Response Algorithm (CAFR) Off DEVICE

Algorithm will be disabled.

Conducted AF-Response Algorithm (CAFR) Off

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead
• Medtronic: collaborator

Study Sites (7)

Universitätsklinikum Aachen

Aachen, 52066, Germany

Location

Berufsgenossenschaftliche Kliniken Bergmannsheil

Bochum, 44789, Germany

Location

Evangelisches und Johanniter Klinikum Duisburg / Dinslaken / Oberhausen GmbH

Duisburg, 47137, Germany

Location

Klinikum der Justus-Liebig-Universität

Giessen, 35385, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Marien-Hospital Herne

Herne, 44625, Germany

Location

Klinikum Siegburg Rhein-Sieg GmbH Krankenhaus und Herzzentrum Siegburg

Siegburg, 53721, Germany

Location

MeSH Terms

Conditions

Heart Failure; Death, Sudden, Cardiac; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Arrest; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac

Study Officials

• Christian Perings, MD

  Marien-Hospital Herne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: December 1, 2003
• Study Completion: January 1, 2007
• Last Updated: July 3, 2025

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (7)