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Ventricular rate during AF in CRT-patients much lower than expected
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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conducted AF-Response Algorithm (CAFR) On | Experimental | CAFR: On
|
|
| Conducted AF-Response Algorithm (CAFR) Off | Active Comparator | CAFR: Off VSR: Off |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conducted AF-Response Algorithm (CAFR) On | Device | Algorithm will be enabled. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amount of biventricular pacing in ON-group compared to OFF-group | 1 month post-implant to 12 months post-implant |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Perings, MD | Marien-Hospital Herne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Aachen | Aachen | 52066 | Germany | |||
| Berufsgenossenschaftliche Kliniken Bergmannsheil |
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| Conducted AF-Response Algorithm (CAFR) Off | Device | Algorithm will be disabled. |
|
| 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 |
| Bochum |
| 44789 |
| Germany |
| Evangelisches und Johanniter Klinikum Duisburg / Dinslaken / Oberhausen GmbH | Duisburg | 47137 | Germany |
| Klinikum der Justus-Liebig-Universität | Giessen | 35385 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Marien-Hospital Herne | Herne | 44625 | Germany |
| Klinikum Siegburg Rhein-Sieg GmbH Krankenhaus und Herzzentrum Siegburg | Siegburg | 53721 | Germany |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D016757 | Death, Sudden, Cardiac |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006323 | Heart Arrest |
| D003645 | Death, Sudden |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001145 | Arrhythmias, Cardiac |
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