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It's the aim of this study to analyze the benefit of personal patient / physician contacts in heart failure patients with remotely monitored implanted cardioverter defibrillators (ICD) or ICD with cardiac resynchronization therapy (CRT-D).
The personal follow up (in clinic or phone calls) will be compared to completely automatic remote follow ups.
All patients will receive remote monitoring for automatic daily alarm checks and will undergo in clinic follow ups in 12 months intervals
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Automatic anonymous ICD/CRTD follow up (quarterly remote follow ups) |
|
| Group B1 | Active Comparator | Personal ICD/CRTD follow up (phone calls + quarterly remote follow ups) |
|
| Group B2 | Active Comparator | Personal ICD/CRTD follow up (Quarterly visits) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quarterly remote follow ups and remote monitoring | Other | Quarterly remote follow ups and remote monitoring |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amount of patients with worsened outcome in reference to Packer's "Heart Failure Clinical Composite Response" | 12 months (between 1 and 13 months post implant) |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | 12 months (between 1 and 13 months post implant) | |
| Heart failure hospitalizations | 12 months (between 1 and 13 months post implant) | |
| Cardiovascular events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Weiss, Prof. Dr. med. | Städtisches Klinikum Lüneburg gGmbH | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald | Bad Friedrichshall | 74177 | Germany | |||
| Asklepios Klinik Bad Oldesloe |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29954340 | Derived | Hansen C, Loges C, Seidl K, Eberhardt F, Troster H, Petrov K, Gronefeld G, Bramlage P, Birkenhauer F, Weiss C. INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients with Remotely Monitored Implanted Cardioverter Defibrillators SysTems (InContact). BMC Cardiovasc Disord. 2018 Jun 28;18(1):131. doi: 10.1186/s12872-018-0864-7. |
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| Quarterly remote follow ups + additional phone calls and remote monitoring | Other | Quarterly remote follow ups + additional phone calls and remote monitoring |
|
| Quarterly in clinic follow ups and remote monitoring | Other | Quarterly in clinic follow ups and remote monitoring |
|
| 12 months (between 1 and 13 months post implant) |
| Number of additional, unscheduled follow ups | 12 months (between 1 and 13 months post implant) |
| Number of follow ups with relevant findings | 12 months (between 1 and 13 months post implant) |
| Number of delivered / appropriate ICD therapies | 12 months (between 1 and 13 months post implant) |
| Quality of life (MLHFQ) | 12 months (between 1 and 13 months post implant) |
| Bad Oldesloe |
| 23843 |
| Germany |
| Segeberger Kliniken GmbH | Bad Segeberg | 23795 | Germany |
| Evangelisches Krankenhaus Bielefeld gGmbH | Bielefeld | 33617 | Germany |
| Evangelisches Krankenhaus Kalk | Cologne | 51103 | Germany |
| Universitätsklinikum Essen (AöR) | Essen | 45122 | Germany |
| Herzkatheterlabor der Kardiologischen Praxis am Krankenhaus Neu-Bethlehem gGmbH | Göttingen | 37073 | Germany |
| Asklepios Klinik St. Georg | Hamburg | 20099 | Germany |
| Asklepios Klinik Barmbek | Hamburg | 22307 | Germany |
| Klinikum Ingolstadt GmbH | Ingolstadt | 85049 | Germany |
| Kardiologische Praxis - Partnergesellschaft | Ludwigsburg | 71634 | Germany |
| Städtisches Klinikum Lüneburg gGmbH | Lüneburg | 21339 | Germany |
| Marienhaus Klinikum St. Elisabeth-Krankenhaus | Neuwied | 56564 | Germany |
| Praxis Dr. med. Balbach / Ruppert | Nürtingen | 72622 | Germany |
| Kardiologische Gemeinschaftspraxis am Park Sanssouci | Potsdam | 14471 | Germany |
| Klinikum Sindelfingen-Böblingen gGmbH | Sindelfingen | 71065 | Germany |
| Marienhospital Stuttgart | Stuttgart | 70199 | Germany |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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