N/A
N=70
IES-ACap: Influence of Atrial Pulse Width in the Behaviour of ACap™ Confirm Algorithm.
Sinus Bradycardia · Sinus Node Disease · Atrio-ventricular Block
Bottom Line
View on ClinicalTrials.gov: NCT00832260 ↗Enrolled (actual)
70
Serious AEs
25.7%
Results posted
Sep 2014
Primary outcome: Primary: Percentage of Patients in Whom ACap™ Confirm Algorithm is Programmed Safely to ON During the First 12 Months. — 61.9 percentage of patients
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients in Whom ACap™ Confirm Algorithm is Programmed Safely to ON During the First 12 Months. |
61.9 | — |
| 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). |
21.4 | — |
Summary
The purpose of this observational study is to collect data regarding the population of patients with a pacemaker implanted.
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;
Data sourced from ClinicalTrials.gov (NCT00832260). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.