Not Yet RecruitingPhase 4ACTRN12606000168550

PreFER MVP For Elective Replacement

PreFER MVP For Elective Replacement: Previously paced patients, coming in For Elective Replacement, using MVP (Managed Ventricular Pacing): to demonstrate the benefit of MVP in pacemaker and implantable carvioverter defibrillator (ICD) patients with a history of right ventricular pacing. The MVP function reduces unnecessary right ventricular pacing which has been shown to induce heart failure. Total mortality and heart failure hospitalization will be evaluated.


Sponsor

Medtronic Inc

Enrollment

801 participants

Start Date

Apr 1, 2006

Study Type

Interventional

Conditions

Summary

This study protocol outlines the methodology and background behind the hypothesis that less ventricular pacing in a pacemaker and ICD is beneficial to the patients with a history of right ventricular pacing. This will be evaluated by comparing the rate of patient deaths and the need for hospitalizations when using less ventricular pacing vs. the normal, standard amount of ventricular pacing.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

  • Patient with dual chamber pacemaker or ICD, paced for at least 2 years, who are due for a replacement of their device, male or female, who have signed the consent form or have a legal guardian willing to sign the consent form.

Exclusion Criteria1

  • Patient with cardiac resynchronization therapy indications, or permanent atrial fibrillation, or permanent atrioventricular block.

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Interventions

Replacement of pacemaker or ICD with a new device featuring MVP. Results after a follow-up period of 2 years with MVP "ON" vs MVP "OFF" will be compared. At the end of the 2 years the doctor will dete

Replacement of pacemaker or ICD with a new device featuring MVP. Results after a follow-up period of 2 years with MVP "ON" vs MVP "OFF" will be compared. At the end of the 2 years the doctor will determine which settings are preferred for the patient to be left on.


Locations(1)

Australia

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ACTRN12606000168550