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

Abbott

Status: Completed

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

Study type: Observational

Funder types: Industry

Identifiers

NCT00832260

CR08004ES

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;