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

Completed

• Conditions: Sinus Bradycardia; Sinus Node Disease; Atrio-ventricular Block

• Registration Number: NCT00832260
• Lead Sponsor: Abbott Medical Devices

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-29
• Study First Submitted QC: 2009-01-29
• Study First Posted: 2009-01-30
• Primary Completion: 2011-06
• Study Completion: 2013-09
• Results First Submitted: 2014-08-27
• Results First Submitted QC: 2014-08-27
• Results First Posted: 2014-09-08
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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