Atrial Fibrillation, Heart Failure, Sudden Cardiac Death
Conditions
Keywords
Heart Failure, Primary Prevention of Sudden Cardiac Death, Secondary Prevention of Sudden Cardiac Death, Cardiac Desynchronization, CRT-D, Cardiac Dyssynchrony
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.
Interventions
DEVICEConducted AF-Response Algorithm (CAFR) On
Algorithm will be enabled.
DEVICEConducted AF-Response Algorithm (CAFR) Off
Algorithm will be disabled.
Sponsors
Medtronic
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of biventricular pacing in ON-group compared to OFF-group | 1 month post-implant to 12 months post-implant |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Characterization of the heart failure (HF)-patient population by means of: echocardiography [left ventricular ejection fraction (LVEF [%]) | Implant to 12 months post-implant |
| Characterization of the heart failure (HF)-patient population by means of: left ventricular end diastolic diameter (LVEDD [mm]) | Implant to 12 months post-implant |
| Characterization of the heart failure (HF)-patient population by means of: left ventricular end systolic diameter (LVESD [mm]) | Implant to 12 months post-implant |
| Characterization of the heart failure (HF)-patient population by means of: left atrial end diastolic diameter (LAEDD [mm])] | Implant to 12 months post-implant |
| Characterization of the heart failure (HF)-patient population by means of: New York Heart Association (NYHA) classification | Implant to 12 months post-implant |
| Characterization of the heart failure (HF)-patient population by means of: 6-minute walk test | Implant to 12 months post-implant |
Countries
Germany
Outcome results
None listed