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The purpose of this study is to provide evidence that the Refined Ventricular Pacing Algorithm leads to clinically relevant reduction (at least 50% reduction) of the incidence of ventricular pacing.
Electrical stimulation in the apex of the right ventricle ( ventricular pacing) usually improves the heart function of patients with a pacemaker and can even be life-saving. However, evidence is accumulating that ventricular pacing may also have undesired long-term cardiac effects. Therefore, it makes sense to limit ventricular pacing to the absolute required minimum. The functionality RVP (Refined Ventricular Pacing) in the C-series 2nd generation pacemakers of Vitatron B.V. Arnhem, the Netherlands is designed to reduce ventricular pacing.
After implantation of the Vitatron C50 D model C50A2 (pacemaker) or Vitatron C60 DR model C60A2 (pacemaker) and a 4-6 weeks stabilization period, proper functioning of pacemaker and leads (stimulation- and sensing parameters) is checked. The pacemakers will be programmed according to predefined settings.
In the following 4-weeks Baseline period diagnostic data (atrial fibrillation burden and percentage of ventricular pacing (% VP)) are collected in the pacemaker memory. Based on these data, patients will be excluded from further participation (patients with more than 15% atrial fibrillation) or subdivided into three groups: (a) < 30% VP (30- VP group), (b) >30% VP, Sick Sinus Syndrome and normal conductivity (SSS group), (c) >30% VP, 1st or 2nd degree AV block. Patients in these three groups will be treated for 4 weeks alternatively with the RVP functionality switched ON or OFF. The order will be determined by randomization. At the end of these two cross-over periods the % VP and the judgment of the patients of the last period will be assessed. Adverse events will be recorded from the moment of study enrolment.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitatron C50 D Model C50A2 of Vitatron C60 DR model C60A2 | Device | |||
| Required pacemaker setting | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Calculation of reduction in % VP when RVP algorithm is ON versus OFF, recording % VP at 4 and 8 weeks after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of possible undesired consequences of the RVP algorithm (e.g. retrograde conduction; AF burden) and adverse events in the periods with the algorithm switched ON versus OFF, 4 and 8 weeks after randomization | ||
| Patient's opinion about treatment (on a six-point scale), at 4 and 8 weeks after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ludwig Binner, MD | Universitätsklinikum Ulm, Ulm, Germany | Study Chair |
| Chris van Groeningen, MD | Vitatron B.V., Arnhem, The Netherlands | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.ö. Krankenhaus der Elisabethinen Linz | Linz | 4010 | Austria | |||
| Fakultni nemocnice u svate Anny v Berne |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10805823 | Background | Connolly SJ, Kerr CR, Gent M, Roberts RS, Yusuf S, Gillis AM, Sami MH, Talajic M, Tang AS, Klein GJ, Lau C, Newman DM. Effects of physiologic pacing versus ventricular pacing on the risk of stroke and death due to cardiovascular causes. Canadian Trial of Physiologic Pacing Investigators. N Engl J Med. 2000 May 11;342(19):1385-91. doi: 10.1056/NEJM200005113421902. | |
| 11451268 |
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| explorative subanalysis on patients with different arrhythmias and/or conducting system defects to investigate in which type of patients the RVP algorithm will have the largest impact on %VP |
| Reproducibility of the %VP assessment, comparison %VP during Baseline periode and 4-week study period with RVP OFF |
| Brno |
| 656 91 |
| Czechia |
| Fakulti Nemocnice, University Hospital of Brno-Bohunice | Brno-Bohunice | 639 00 | Czechia |
| University Hospital with Polyclinics Ostrava | Ostrava | 708 50 | Czechia |
| Kardiologicka kllinika | Prague | 100 34 | Czechia |
| Nemocnice Na Homolce Hospital | Prague | 150 30 | Czechia |
| Masarykova Nemocnice | Ústà nad Labem | 40113 | Czechia |
| Hillerod Sygehus | Hillerød | 3400 | Denmark |
| Vejle Sygehus | Vejle | 7100 | Denmark |
| Tampere University Central Hospital | Tampere | 33521 | Finland |
| University of Oulu, Depart. of Internal Medicine, Div. of Cardiology | University of Oulu | 9000 14 | Finland |
| Elisabeth Krankenhaus | Essen | 45138 | Germany |
| Stadt. Klinikum Leverkussen | Leverkussen | 51375 | Germany |
| Deutschen Herzzentrum Munchen des Freistaates Bayern Klinik an der TU Munchen | München | 80636 | Germany |
| Stadtisches Klinikum Pforzheim | Pforazheim | 75175 | Germany |
| Kreiskrankenhaus Rottweil | Rottweil | 78628 | Germany |
| Universitätsklinikum Ulm | Ulm | 89081 | Germany |
| Arcispedale S. Maria Nuova | Reggio Emilia | Emilia-Romagna | 42100 | Italy |
| San Camillo De' Lellis | Rieti | 02100 | Italy |
| Meander Medisch Centrum, Lokatie Lichtenberg | Amersfoort | 3818 ES | Netherlands |
| St. Lucas Andreas Ziekenhuis | Amsterdam | 1061 AE | Netherlands |
| Catharina Hospital | Eindhoven | 5623 EJ | Netherlands |
| Bronovo Ziekenhuis | The Hague | 2597 AX | Netherlands |
| Hospital Nr.: 26 | Saint Petersburg | 199106 | Russia |
| Pokrovskiy Hospital | Saint Petersburg | 199106 | Russia |
| Medicinkliniken | Borås | 501 82 | Sweden |
| Karolinska University Hospital Hjartkliniken | Stockholm | 141 86 | Sweden |
| Kantonsspital Kardiologie | Basel | 4031 | Switzerland |
| Inselspital Bern, Schweizer Herz- und Gefasszentrum | Bern | 3010 | Switzerland |
| Blackpool Victoria Hospital | Blackpool | FY3 8NR | United Kingdom |
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| ID | Term |
|---|---|
| D001919 | Bradycardia |
| D012804 | Sick Sinus Syndrome |
| D054537 | Atrioventricular Block |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001146 | Arrhythmia, Sinus |
| D006327 | Heart Block |
| D000075224 | Cardiac Conduction System Disease |
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