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

Abbott Medical Devices0 sites70 target enrollmentJanuary 2009

ConditionsSinus Bradycardia Sinus Node Disease Atrio-ventricular Block

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sinus Bradycardia
Sponsor: Abbott Medical Devices
Enrollment: 70
Primary Endpoint: Percentage of Patients in Whom ACap™ Confirm Algorithm is Programmed Safely to ON During the First 12 Months.
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

January 2009

End Date

September 2013

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Abbott Medical Devices

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient has an indication for implantation of a dual-chamber pacemaker;
•Patient is older than 18 years of age
•Patient has signed the study specific Informed consent document.
•Primo implant.

Exclusion Criteria

•Patient is pregnant or nursing
•Patient is less than 18 years of age
•Patient is in New York Heart Association (NYHA) class III and IV.
•Patient has a pacemaker replacement;
•Patient is unable to attend the follow-up visits;

Outcomes

Primary Outcomes

Percentage of Patients in Whom ACap™ Confirm Algorithm is Programmed Safely to ON During the First 12 Months.

Time Frame: 12 months

Secondary Outcomes

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).(12 months)