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

February 14, 2017 updated by: Medtronic Bakken Research Center

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Amount of biventricular pacing in ON-group compared to OFF-group
Time Frame: 1 month post-implant to 12 months post-implant
1 month post-implant to 12 months post-implant

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
Implant to 12 months post-implant
Occurrence and evaluation of rhythm disturbances: ventricular arrhythmias
Time Frame: Implant to 12 months post-implant
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
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
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
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
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
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
Implant to 12 months post-implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Bakken Research Center

Collaborators

Medtronic

Investigators

  • Principal Investigator: Christian Perings, MD, Marien-Hospital Herne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Actual)

February 15, 2017

Last Update Submitted That Met QC Criteria

February 14, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEN_G_CA_6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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