Clinical Trial: EnTRINSIC - EnPulse Trial on Search AV+ Influence

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: EnPulse Trial on Search AV+ Influence

Brief Summary: Right ventricular apical pacing in patients treated with a pacemaker is unnecessary in cases where patients have stable atrioventricular (AV)-conduction. Recent findings demonstrate that pacing even might have unfavourable effects, especially if patients suffer from additional cardiac diseases such as heart failure. The Search AV+ algorithm was designed to avoid ventricular pacing and support intrinsic AV-conduction in order to avoid possible detrimental effects of right ventricular apical pacing. The goal of the EnTRINSIC study is to assess the amount of ventricular stimulation, the amount of hospitalizations, the occurrence of atrial fibrillation and the usage of drugs in patients treated with pacemakers with an activated Search AV+ algorithm versus patients treated with an individual optimization of the pacemaker settings to minimize the amount of right ventricular pacing.

Detailed Summary:
Sponsor: Medtronic Bakken Research Center

Current Primary Outcome: Amount of right ventricular pacing [ Time Frame: Baseline to 36 months post-implant ]

Original Primary Outcome: Amount of right ventricular pacing

Current Secondary Outcome:

  • Change in intrinsic AV delay [ Time Frame: Baseline to 36 months post-implant ]
  • Hospitalizations because of symptomatic heart failure [ Time Frame: Baseline to 36 months post-implant ]
  • Hospitalizations because of symptomatic atrial fibrillation [ Time Frame: Baseline to 36 months post-implant ]
  • Medication [ Time Frame: Baseline to 36 months post-implant ]


Original Secondary Outcome:

  • Change in intrinsic AV delay
  • Hospitalizations because of symptomatic heart failure
  • Hospitalizations because of symptomatic atrial fibrillation
  • Medication


Information By: Medtronic Bakken Research Center

Dates:
Date Received: September 9, 2005
Date Started: February 2004
Date Completion:
Last Updated: February 14, 2017
Last Verified: February 2017