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

Primary Purpose

Bradycardia; Sick Sinus Syndrome, AV Block

Status
Unknown status
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Vitatron C50 D Model C50A2 of Vitatron C60 DR model C60A2
Required pacemaker setting
Sponsored by
Medtronic BRC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bradycardia; Sick Sinus Syndrome, AV Block focused on measuring Refined ventricular pacing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • A.ö. Krankenhaus der Elisabethinen Linz
  • Fakulti Nemocnice, University Hospital of Brno-Bohunice
  • Fakultni nemocnice u svate Anny v Berne
  • University Hospital with Polyclinics Ostrava
  • Nemocnice Na Homolce Hospital
  • Kardiologicka kllinika
  • Masarykova Nemocnice
  • Hillerod Sygehus
  • Vejle Sygehus
  • Tampere University Central Hospital
  • University of Oulu, Depart. of Internal Medicine, Div. of Cardiology
  • Elisabeth Krankenhaus
  • Stadt. Klinikum Leverkussen
  • Deutschen Herzzentrum Munchen des Freistaates Bayern Klinik an der TU Munchen
  • Stadtisches Klinikum Pforzheim
  • Kreiskrankenhaus Rottweil
  • Universitätsklinikum Ulm
  • Arcispedale S. Maria Nuova
  • San Camillo De' Lellis
  • Meander Medisch Centrum, Lokatie Lichtenberg
  • St. Lucas Andreas Ziekenhuis
  • Bronovo Ziekenhuis
  • Catharina Hospital
  • Hospital Nr.: 26
  • Pokrovskiy Hospital
  • Medicinkliniken
  • Karolinska University Hospital Hjartkliniken
  • Kantonsspital Kardiologie
  • Inselspital Bern, Schweizer Herz- und Gefasszentrum
  • Blackpool Victoria Hospital

Outcomes

Primary Outcome Measures

Calculation of reduction in % VP when RVP algorithm is ON versus OFF, recording % VP at 4 and 8 weeks after randomization

Secondary Outcome Measures

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

Full Information

First Posted
September 7, 2005
Last Updated
August 1, 2011
Sponsor
Medtronic BRC
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1. Study Identification

Unique Protocol Identification Number
NCT00156741
Brief Title
Efficacy of a Pacemaker Algorithm in Promotion of the Intrinsic Heart Activity.
Official Title
IntAct, Study on Promotion of Intrinsic Activity.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Medtronic BRC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia; Sick Sinus Syndrome, AV Block
Keywords
Refined ventricular pacing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
150 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Vitatron C50 D Model C50A2 of Vitatron C60 DR model C60A2
Intervention Type
Procedure
Intervention Name(s)
Required pacemaker setting
Primary Outcome Measure Information:
Title
Calculation of reduction in % VP when RVP algorithm is ON versus OFF, recording % VP at 4 and 8 weeks after randomization
Secondary Outcome Measure Information:
Title
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
Title
Patient's opinion about treatment (on a six-point scale), at 4 and 8 weeks after randomization
Title
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
Title
Reproducibility of the %VP assessment, comparison %VP during Baseline periode and 4-week study period with RVP OFF

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ludwig Binner, MD
Organizational Affiliation
Universitätsklinikum Ulm, Ulm, Germany
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Chris van Groeningen, MD
Organizational Affiliation
Vitatron B.V., Arnhem, The Netherlands
Official's Role
Study Director
Facility Information:
Facility Name
A.ö. Krankenhaus der Elisabethinen Linz
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Fakulti Nemocnice, University Hospital of Brno-Bohunice
City
Brno- Bohunice
ZIP/Postal Code
639 00
Country
Czech Republic
Facility Name
Fakultni nemocnice u svate Anny v Berne
City
Brno
ZIP/Postal Code
656 91
Country
Czech Republic
Facility Name
University Hospital with Polyclinics Ostrava
City
Ostrava
ZIP/Postal Code
708 50
Country
Czech Republic
Facility Name
Nemocnice Na Homolce Hospital
City
Prague
ZIP/Postal Code
150 30
Country
Czech Republic
Facility Name
Kardiologicka kllinika
City
Praha 10
ZIP/Postal Code
100 34
Country
Czech Republic
Facility Name
Masarykova Nemocnice
City
Usti nad Labem
ZIP/Postal Code
40113
Country
Czech Republic
Facility Name
Hillerod Sygehus
City
Hillerod
ZIP/Postal Code
3400
Country
Denmark
Facility Name
Vejle Sygehus
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Tampere University Central Hospital
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Facility Name
University of Oulu, Depart. of Internal Medicine, Div. of Cardiology
City
University of Oulu
ZIP/Postal Code
9000 14
Country
Finland
Facility Name
Elisabeth Krankenhaus
City
Essen
ZIP/Postal Code
45138
Country
Germany
Facility Name
Stadt. Klinikum Leverkussen
City
Leverkussen
ZIP/Postal Code
51375
Country
Germany
Facility Name
Deutschen Herzzentrum Munchen des Freistaates Bayern Klinik an der TU Munchen
City
Munchen
ZIP/Postal Code
80636
Country
Germany
Facility Name
Stadtisches Klinikum Pforzheim
City
Pforazheim
ZIP/Postal Code
75175
Country
Germany
Facility Name
Kreiskrankenhaus Rottweil
City
Rottweil
ZIP/Postal Code
78628
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Arcispedale S. Maria Nuova
City
Reggio Emilia
State/Province
Emilia Romagna
ZIP/Postal Code
42100
Country
Italy
Facility Name
San Camillo De' Lellis
City
Rieti
ZIP/Postal Code
02100
Country
Italy
Facility Name
Meander Medisch Centrum, Lokatie Lichtenberg
City
Amersfoort
ZIP/Postal Code
3818 ES
Country
Netherlands
Facility Name
St. Lucas Andreas Ziekenhuis
City
Amsterdam
ZIP/Postal Code
1061 AE
Country
Netherlands
Facility Name
Bronovo Ziekenhuis
City
Den Haag
ZIP/Postal Code
2597 AX
Country
Netherlands
Facility Name
Catharina Hospital
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Hospital Nr.: 26
City
Saint-Petersburg
ZIP/Postal Code
199106
Country
Russian Federation
Facility Name
Pokrovskiy Hospital
City
Saint-Petersburg
ZIP/Postal Code
199106
Country
Russian Federation
Facility Name
Medicinkliniken
City
Boras
ZIP/Postal Code
501 82
Country
Sweden
Facility Name
Karolinska University Hospital Hjartkliniken
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Kantonsspital Kardiologie
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Inselspital Bern, Schweizer Herz- und Gefasszentrum
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Blackpool Victoria Hospital
City
Blackpool
ZIP/Postal Code
FY3 8NR
Country
United Kingdom

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

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