Atrio-ventricular Block, Sinus Bradycardia, Sinus Node Disease
Conditions
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.
Interventions
None listed
Sponsors
Abbott Medical Devices
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Patients in Whom ACap™ Confirm Algorithm is Programmed Safely to ON During the First 12 Months. | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zephyr Pacemaker Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical | 70 |
| Total | 70 |
Baseline characteristics
| Characteristic | Zephyr Pacemaker |
|---|---|
| Age, Continuous | 73 years STANDARD_DEVIATION 8.4 |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 70 |
| serious Total, serious adverse events | 18 / 70 |
Outcome results
Primary
Percentage of Patients in Whom ACap™ Confirm Algorithm is Programmed Safely to ON During the First 12 Months.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zephyr Pacemaker | Percentage of Patients in Whom ACap™ Confirm Algorithm is Programmed Safely to ON During the First 12 Months. | 61.9 percentage of patients |
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).
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zephyr Pacemaker | 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 percentage of patients |