Efficacy of a Pacemaker Algorithm in Promotion of the Intrinsic Heart Activity.

NCT ID: NCT00156741

Last Updated: 2011-08-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2006-04-30

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.

Conditions

Bradycardia; Sick Sinus Syndrome, AV Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Vitatron C50 D Model C50A2 of Vitatron C60 DR model C60A2

Intervention Type: DEVICE

Required pacemaker setting

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic BRC

INDUSTRY

Sponsor Role: lead

Principal Investigators

Ludwig Binner, MD

Role: STUDY_CHAIR

Universitätsklinikum Ulm, Ulm, Germany

Chris van Groeningen, MD

Role: STUDY_DIRECTOR

Vitatron B.V., Arnhem, The Netherlands

Locations

A.ö. Krankenhaus der Elisabethinen Linz

Linz, , Austria

Fakultni nemocnice u svate Anny v Berne

Brno, , Czechia

Fakulti Nemocnice, University Hospital of Brno-Bohunice

Brno- Bohunice, , Czechia

University Hospital with Polyclinics Ostrava

Ostrava, , Czechia

Kardiologicka kllinika

Prague, , Czechia

Nemocnice Na Homolce Hospital

Prague, , Czechia

Masarykova Nemocnice

Ústí nad Labem, , Czechia

Hillerod Sygehus

Hillerød, , Denmark

Vejle Sygehus

Vejle, , Denmark

Tampere University Central Hospital

Tampere, , Finland

University of Oulu, Depart. of Internal Medicine, Div. of Cardiology

University of Oulu, , Finland

Elisabeth Krankenhaus

Essen, , Germany

Stadt. Klinikum Leverkussen

Leverkussen, , Germany

Deutschen Herzzentrum Munchen des Freistaates Bayern Klinik an der TU Munchen

München, , Germany

Stadtisches Klinikum Pforzheim

Pforazheim, , Germany

Kreiskrankenhaus Rottweil

Rottweil, , Germany

Universitätsklinikum Ulm

Ulm, , Germany

Arcispedale S. Maria Nuova

Reggio Emilia, Emilia-Romagna, Italy

San Camillo De' Lellis

Rieti, , Italy

Meander Medisch Centrum, Lokatie Lichtenberg

Amersfoort, , Netherlands

St. Lucas Andreas Ziekenhuis

Amsterdam, , Netherlands

Catharina Hospital

Eindhoven, , Netherlands

Bronovo Ziekenhuis

The Hague, , Netherlands

Hospital Nr.: 26

Saint Petersburg, , Russia

Pokrovskiy Hospital

Saint Petersburg, , Russia

Medicinkliniken

Borås, , Sweden

Karolinska University Hospital Hjartkliniken

Stockholm, , Sweden

Kantonsspital Kardiologie

Basel, , Switzerland

Inselspital Bern, Schweizer Herz- und Gefasszentrum

Bern, , Switzerland

Blackpool Victoria Hospital

Blackpool, , United Kingdom

Countries

Austria; Czechia; Denmark; Finland; Germany; Italy; Netherlands; Russia; Sweden; Switzerland; United Kingdom

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Other Identifiers

CMD 287

Identifier Type: -

Identifier Source: org_study_id