NCT00832260CompletedNot Applicable
Influence of Atrial Pulse Width in the Behaviour of ACap™ Confirm Algorithm.
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- 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.
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
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