Back to resultsCORE: Study to Evaluate the Conducted AF-Response-Algorithm in Patients Suffering From Heart Failure and Atrial Fibrillation
Primary Purpose
Heart Failure, Sudden Cardiac Death, Atrial Fibrillation
Status
Terminated
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Conducted AF-Response Algorithm (CAFR) On
Conducted AF-Response Algorithm (CAFR) Off
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Primary Prevention of Sudden Cardiac Death, Secondary Prevention of Sudden Cardiac Death, Cardiac Desynchronization, CRT-D, Cardiac Dyssynchrony
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
Sites / Locations
- Universitätsklinikum Aachen
- Berufsgenossenschaftliche Kliniken Bergmannsheil
- Evangelisches und Johanniter Klinikum Duisburg / Dinslaken / Oberhausen GmbH
- Klinikum der Justus-Liebig-Universität
- Medizinische Hochschule Hannover
- Marien-Hospital Herne
- Klinikum Siegburg Rhein-Sieg GmbH Krankenhaus und Herzzentrum Siegburg
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Conducted AF-Response Algorithm (CAFR) On
Conducted AF-Response Algorithm (CAFR) Off
Arm Description
CAFR: On Level medium Max. Rate: 110ppm VSR: Off
CAFR: Off VSR: Off
Outcomes
Primary Outcome Measures
Amount of biventricular pacing in ON-group compared to OFF-group
Secondary Outcome Measures
Influence of the conducted AF response algorithm on the ventricular heart rate during atrial fibrillation
Amount of patients who will be free from AF during the study
Amount of hospitalizations due to heart failure (amount and duration in days)
Occurrence and evaluation of rhythm disturbances: atrial arrhythmias (atrial tachyarrhythmia [AT]/AF episodes [h/day])
Occurrence and evaluation of rhythm disturbances: ventricular arrhythmias
Characterization of the heart failure (HF)-patient population by means of: echocardiography [left ventricular ejection fraction (LVEF [%])
Characterization of the heart failure (HF)-patient population by means of: left ventricular end diastolic diameter (LVEDD [mm])
Characterization of the heart failure (HF)-patient population by means of: left ventricular end systolic diameter (LVESD [mm])
Characterization of the heart failure (HF)-patient population by means of: left atrial end diastolic diameter (LAEDD [mm])]
Characterization of the heart failure (HF)-patient population by means of: New York Heart Association (NYHA) classification
Characterization of the heart failure (HF)-patient population by means of: 6-minute walk test
Full Information
NCT ID
NCT00170313
First Posted
September 13, 2005
Last Updated
February 14, 2017
Sponsor
Medtronic Bakken Research Center
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT00170313
Brief Title
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
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
Ventricular rate during AF in CRT-patients much lower than expected
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Bakken Research Center
Collaborators
Medtronic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conducted AF-Response Algorithm (CAFR) On
Arm Type
Experimental
Arm Description
CAFR: On
Level medium
Max. Rate: 110ppm VSR: Off
Arm Title
Conducted AF-Response Algorithm (CAFR) Off
Arm Type
Active Comparator
Arm Description
CAFR: Off VSR: Off
Intervention Type
Device
Intervention Name(s)
Conducted AF-Response Algorithm (CAFR) On
Intervention Description
Algorithm will be enabled.
Intervention Type
Device
Intervention Name(s)
Conducted AF-Response Algorithm (CAFR) Off
Intervention Description
Algorithm will be disabled.
Primary Outcome Measure Information:
Title
Amount of biventricular pacing in ON-group compared to OFF-group
Time Frame
1 month post-implant to 12 months post-implant
Secondary Outcome Measure Information:
Title
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
Title
Amount of patients who will be free from AF during the study
Time Frame
Implant to 12 months post-implant
Title
Amount of hospitalizations due to heart failure (amount and duration in days)
Time Frame
Implant to 12 months post-implant
Title
Occurrence and evaluation of rhythm disturbances: atrial arrhythmias (atrial tachyarrhythmia [AT]/AF episodes [h/day])
Time Frame
Implant to 12 months post-implant
Title
Occurrence and evaluation of rhythm disturbances: ventricular arrhythmias
Time Frame
Implant to 12 months post-implant
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Characterization of the heart failure (HF)-patient population by means of: 6-minute walk test
Time Frame
Implant to 12 months post-implant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Perings, MD
Organizational Affiliation
Marien-Hospital Herne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Aachen
City
Aachen
ZIP/Postal Code
52066
Country
Germany
Facility Name
Berufsgenossenschaftliche Kliniken Bergmannsheil
City
Bochum
ZIP/Postal Code
44789
Country
Germany
Facility Name
Evangelisches und Johanniter Klinikum Duisburg / Dinslaken / Oberhausen GmbH
City
Duisburg
ZIP/Postal Code
47137
Country
Germany
Facility Name
Klinikum der Justus-Liebig-Universität
City
Gießen
ZIP/Postal Code
35385
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Marien-Hospital Herne
City
Herne
ZIP/Postal Code
44625
Country
Germany
Facility Name
Klinikum Siegburg Rhein-Sieg GmbH Krankenhaus und Herzzentrum Siegburg
City
Siegburg
ZIP/Postal Code
53721
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
CORE: Study to Evaluate the Conducted AF-Response-Algorithm in Patients Suffering From Heart Failure and Atrial Fibrillation
We'll reach out to this number within 24 hrs