Clinical trial NCT00156741: Efficacy of a Pacemaker Algorithm in Promotion of the Intrinsic Heart Activity.
Official title: IntAct, Study on Promotion of Intrinsic Activity.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bradycardia; Sick Sinus Syndrome, AV Block
Keywords: Refined ventricular pacing
Lead sponsor: Medtronic BRC
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Calculation of reduction in % VP when RVP algorithm is ON versus OFF, recording % VP at 4 and 8 weeks after randomization
Secondary outcomes:
measure: 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
measure: Patient's opinion about treatment (on a six-point scale), at 4 and 8 weeks after randomization
measure: 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
measure: Reproducibility of the %VP assessment, comparison %VP during Baseline periode and 4-week study period with RVP OFF
Other outcomes:
Locations:
city: Linz
country: Austria
facility: A.ö. Krankenhaus der Elisabethinen Linz
city: Brno- Bohunice
country: Czech Republic
facility: Fakulti Nemocnice, University Hospital of Brno-Bohunice
city: Brno
country: Czech Republic
facility: Fakultni nemocnice u svate Anny v Berne
city: Ostrava
country: Czech Republic
facility: University Hospital with Polyclinics Ostrava
city: Prague
country: Czech Republic
facility: Nemocnice Na Homolce Hospital
city: Praha 10
country: Czech Republic
facility: Kardiologicka kllinika
city: Usti nad Labem
country: Czech Republic
facility: Masarykova Nemocnice
city: Hillerod
country: Denmark
facility: Hillerod Sygehus
city: Vejle
country: Denmark
facility: Vejle Sygehus
city: Tampere
country: Finland
facility: Tampere University Central Hospital
city: University of Oulu
country: Finland
facility: University of Oulu, Depart. of Internal Medicine, Div. of Cardiology
city: Essen
country: Germany
facility: Elisabeth Krankenhaus
city: Leverkussen
country: Germany
facility: Stadt. Klinikum Leverkussen
city: Munchen
country: Germany
facility: Deutschen Herzzentrum Munchen des Freistaates Bayern Klinik an der TU Munchen
city: Pforazheim
country: Germany
facility: Stadtisches Klinikum Pforzheim
city: Rottweil
country: Germany
facility: Kreiskrankenhaus Rottweil
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Reggio Emilia
country: Italy
facility: Arcispedale S. Maria Nuova
state: Emilia Romagna
city: Rieti
country: Italy
facility: San Camillo De' Lellis
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum, Lokatie Lichtenberg
city: Amsterdam
country: Netherlands
facility: St. Lucas Andreas Ziekenhuis
city: Den Haag
country: Netherlands
facility: Bronovo Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
city: Saint-Petersburg
country: Russian Federation
facility: Hospital Nr.: 26
city: Saint-Petersburg
country: Russian Federation
facility: Pokrovskiy Hospital
city: Boras
country: Sweden
facility: Medicinkliniken
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Hjartkliniken
city: Basel
country: Switzerland
facility: Kantonsspital Kardiologie
city: Bern
country: Switzerland
facility: Inselspital Bern, Schweizer Herz- und Gefasszentrum
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital
Study officials:
affiliation: Universitätsklinikum Ulm, Ulm, Germany
name: Ludwig Binner, MD
role: STUDY_CHAIR
affiliation: Vitatron B.V., Arnhem, The Netherlands
name: Chris van Groeningen, MD
role: STUDY_DIRECTOR
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