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

This study has been terminated.
(Ventricular rate during AF in CRT-patients much lower than expected)
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00170313
First received: September 13, 2005
Last updated: February 14, 2017
Last verified: January 2017
  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 (CAFR) On
Device: Conducted AF-Response Algorithm (CAFR) Off
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (masked role unspecified)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • Amount of biventricular pacing in ON-group compared to OFF-group [ Time Frame: 1 month post-implant to 12 months post-implant ]

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

Estimated Enrollment: 100
Study Start Date: December 2003
Study Completion Date: January 2007
Arms Assigned Interventions
Experimental: Conducted AF-Response Algorithm (CAFR) On

CAFR: On

  • Level medium
  • Max. Rate: 110ppm VSR: Off
Device: Conducted AF-Response Algorithm (CAFR) On
Algorithm will be enabled.
Active Comparator: Conducted AF-Response Algorithm (CAFR) Off
CAFR: Off VSR: Off
Device: Conducted AF-Response Algorithm (CAFR) Off
Algorithm will be disabled.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Universitätsklinikum Aachen
Aachen, Germany, 52066
Berufsgenossenschaftliche Kliniken Bergmannsheil
Bochum, Germany, 44789
Evangelisches und Johanniter Klinikum Duisburg / Dinslaken / Oberhausen GmbH
Duisburg, Germany, 47137
Klinikum der Justus-Liebig-Universität
Gießen, Germany, 35385
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Marien-Hospital Herne
Herne, Germany, 44625
Klinikum Siegburg Rhein-Sieg GmbH Krankenhaus und Herzzentrum Siegburg
Siegburg, Germany, 53721
Sponsors and Collaborators
Medtronic Bakken Research Center
Medtronic
Investigators
Principal Investigator: Christian Perings, MD Marien-Hospital Herne
  More Information

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00170313     History of Changes
Other Study ID Numbers: CEN_G_CA_6
Study First Received: September 13, 2005
Last Updated: February 14, 2017
Individual Participant Data  
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Heart Failure
Atrial Fibrillation
Death
Death, Sudden, Cardiac
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Heart Arrest
Death, Sudden

ClinicalTrials.gov processed this record on May 25, 2017