Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00156741
Status:
UNKNOWN
Last Update Posted:
2011-08-02
First Post:
2005-09-07
Brief Title:
Efficacy of a Pacemaker Algorithm in Promotion of the Intrinsic Heart Activity
Sponsor:
Medtronic BRC
Organization:
Medtronic BRC
Study Overview
Official Title:
IntAct Study on Promotion of Intrinsic Activity
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 BV 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None