Efficacy of a Pacemaker Algorithm in Promotion of the Intrinsic Heart Activity.
- Conditions
- Bradycardia; Sick Sinus Syndrome, AV Block
- Registration Number
- NCT00156741
- Lead Sponsor
- Medtronic BRC
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
- Patients shall be willing to sign the Patient Informed Consent for this study
- Patients shall have at least one of the following indications for a pacemaker: - Sick Sinus Syndrome with normal QRS complexes
- First degree AV block with a PR interval <220 ms for patients < 70 years of age, or <_ 260 for patients over 70 years
- Second-degree AV block, mobitz I (wenckebach) or mobitz II
- Patients shall be available for follow-up for the duration of their participation.
- Patients involved in another investigation study conducted in parallel to this study
- Patients younger than 18 years of age and/or patients that do NOT meet other local requirements for participation
- Pregnant patients
- Patients with lead integrity problems (and the lead is not being replaced)
- Patients with persistant AF
- Patients with a complete AV block
- Patients with NYHA (New York Heart Association0 class III and IV
- Patients who underwent thoracic surgery in the last three months or are expected to have in the near future
- Patients with a 2:1 block
- Patients with a life expectancy less than half a year
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Calculation of reduction in % VP when RVP algorithm is ON versus OFF, recording % VP at 4 and 8 weeks after randomization
- Secondary Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (30)
Fakultni nemocnice u svate Anny v Berne
๐จ๐ฟBrno, Czech Republic
Nemocnice Na Homolce Hospital
๐จ๐ฟPrague, Czech Republic
A.รถ. Krankenhaus der Elisabethinen Linz
๐ฆ๐นLinz, Austria
University Hospital with Polyclinics Ostrava
๐จ๐ฟOstrava, Czech Republic
Masarykova Nemocnice
๐จ๐ฟUsti nad Labem, Czech Republic
Tampere University Central Hospital
๐ซ๐ฎTampere, Finland
Kantonsspital Kardiologie
๐จ๐ญBasel, Switzerland
St. Lucas Andreas Ziekenhuis
๐ณ๐ฑAmsterdam, Netherlands
Meander Medisch Centrum, Lokatie Lichtenberg
๐ณ๐ฑAmersfoort, Netherlands
Arcispedale S. Maria Nuova
๐ฎ๐นReggio Emilia, Emilia Romagna, Italy
San Camillo De' Lellis
๐ฎ๐นRieti, Italy
Hillerod Sygehus
๐ฉ๐ฐHillerod, Denmark
Vejle Sygehus
๐ฉ๐ฐVejle, Denmark
Stadtisches Klinikum Pforzheim
๐ฉ๐ชPforazheim, Germany
Deutschen Herzzentrum Munchen des Freistaates Bayern Klinik an der TU Munchen
๐ฉ๐ชMunchen, Germany
Kreiskrankenhaus Rottweil
๐ฉ๐ชRottweil, Germany
Fakulti Nemocnice, University Hospital of Brno-Bohunice
๐จ๐ฟBrno- Bohunice, Czech Republic
Kardiologicka kllinika
๐จ๐ฟPraha 10, Czech Republic
Stadt. Klinikum Leverkussen
๐ฉ๐ชLeverkussen, Germany
University of Oulu, Depart. of Internal Medicine, Div. of Cardiology
๐ซ๐ฎUniversity of Oulu, Finland
Universitรคtsklinikum Ulm
๐ฉ๐ชUlm, Germany
Hospital Nr.: 26
๐ท๐บSaint-Petersburg, Russian Federation
Catharina Hospital
๐ณ๐ฑEindhoven, Netherlands
Medicinkliniken
๐ธ๐ชBoras, Sweden
Bronovo Ziekenhuis
๐ณ๐ฑDen Haag, Netherlands
Karolinska University Hospital Hjartkliniken
๐ธ๐ชStockholm, Sweden
Blackpool Victoria Hospital
๐ฌ๐งBlackpool, United Kingdom
Inselspital Bern, Schweizer Herz- und Gefasszentrum
๐จ๐ญBern, Switzerland
Elisabeth Krankenhaus
๐ฉ๐ชEssen, Germany
Pokrovskiy Hospital
๐ท๐บSaint-Petersburg, Russian Federation