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Protocol pre-specified interim analysis showed that difference between groups was too small to reach significance.
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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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Right ventricular apical pacing in patients treated with a pacemaker is unnecessary in cases where patients have stable atrioventricular (AV)-conduction. Recent findings demonstrate that pacing even might have unfavourable effects, especially if patients suffer from additional cardiac diseases such as heart failure. The Search AV+ algorithm was designed to avoid ventricular pacing and support intrinsic AV-conduction in order to avoid possible detrimental effects of right ventricular apical pacing. The goal of the EnTRINSIC study is to assess the amount of ventricular stimulation, the amount of hospitalizations, the occurrence of atrial fibrillation and the usage of drugs in patients treated with pacemakers with an activated Search AV+ algorithm versus patients treated with an individual optimization of the pacemaker settings to minimize the amount of right ventricular pacing.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Search AV+ algorithm | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of right ventricular pacing | Baseline to 36 months post-implant |
| Measure | Description | Time Frame |
|---|---|---|
| Change in intrinsic AV delay | Baseline to 36 months post-implant | |
| Hospitalizations because of symptomatic heart failure | Baseline to 36 months post-implant | |
| Hospitalizations because of symptomatic atrial fibrillation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Jakob, MD | Knappschaftskrankenhaus Sulzbach | Principal Investigator |
| Peter Lamm, MD | Klinikum der Universität München Großhadern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Großhadern Herzchirurgische Klinik und Poliklinik | Munich | Bavaria | 81377 | Germany | ||
| Internistische Praxis Dr. Med. Schade |
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| Label | URL |
|---|---|
| Knappschaftskrankenhaus Sulzbach | View source |
| Klinikum der Universität München -Großhadern | View source |
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| ID | Term |
|---|---|
| D001146 | Arrhythmia, Sinus |
| D012804 | Sick Sinus Syndrome |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Baseline to 36 months post-implant |
| Medication | Baseline to 36 months post-implant |
| Berlin |
| 13187 |
| Germany |
| St. Josefs Hospital | Bochum | 44791 | Germany |
| Praxis Dr. Med. Markert | Gaggenau | 76571 | Germany |
| Krankenhaus Martha Maria Halle | Halle | Germany |
| Universitätsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| St. Vincentius Kliniken | Karlsruhe | 76135 | Germany |
| Vinzentius Krankenhaus | Landau | 76829 | Germany |
| Klinikum der Johannes-Gutenberg-Universität | Mainz | 55131 | Germany |
| Städtisches Klinikum Neunkirchen | Neunkirchen | 66538 | Germany |
| Kreiskrankenhaus Ottweiler | Ottweiler | 66564 | Germany |
| Knappschaftskrankenhaus Sulzbach, Medizinische Klinik | Sulzbach | 66280 | Germany |
| Josephs-Hospital | Warendorf | 48231 | Germany |
| Gemeinschaftspraxis Dr. Tamm/Dr. Hon | Wittenberg | Germany |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006327 | Heart Block |
| D000075224 | Cardiac Conduction System Disease |