Clinical Trial: IES-ACap: Influence of Atrial Pulse Width in the Behaviour of ACap™ Confirm Algorithm.

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Influence of Atrial Pulse Width in the Behaviour of ACap™ Confirm Algorithm.

Brief Summary: The purpose of this observational study is to collect data regarding the population of patients with a pacemaker implanted.

Detailed Summary: The purpose of this observational study is to collect data regarding the population of patients whit a Zephyr™ pacemaker implanted, models 5826 and 5820, and active or passive fixation leads , when the Algorithms Acap Confirm, which automatically regulates the Atrial Pulse Width, is enabled.
Sponsor: St. Jude Medical

Current Primary Outcome: Percentage of Patients in Whom ACap™ Confirm Algorithm is Programmed Safely to ON During the First 12 Months. [ Time Frame: 12 months ]

Original Primary Outcome: Pulse width that may be considered as standard value when ACap™ Confirm want to be enabled and in which phase, short, medium or long term Acap™Confirm may be enabled during the patient follow ups according the standard of care. [ Time Frame: 12 months ]

Current Secondary Outcome: Percentage of Patients in Whom ACap™ Confirm Algorithm is Recommended at a Pulse Width of 0.4 Milliseconds (ms) During All Follow-ups (Implant, Staples Removal, 3, 6, 9 and 12 Months). [ Time Frame: 12 months ]

Original Secondary Outcome: The short, medium and long term variability of the relation between atrial polarization and Evoked Response. [ Time Frame: 12 months ]

Information By: St. Jude Medical

Dates:
Date Received: January 29, 2009
Date Started: January 2009
Date Completion:
Last Updated: September 25, 2014
Last Verified: September 2014