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

Sinus Node Disease Clinical Trial

— IES-ACap  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00832260
• Other study ID #: CR08004ES
• Status: Completed
• Start date: January 2009
• Est. completion date: September 2013

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2013
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Atrio-ventricular Block
• Atrioventricular Block
• Bradycardia
• Sick Sinus Syndrome
• Sinus Bradycardia
• Sinus Node Disease

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients in Whom ACap™ Confirm Algorithm is Programmed Safely to ON During the First 12 Months.		12 months
Secondary	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