Bradycardia
Conditions
Keywords
Pacemaker, Bradycardia
Brief summary
The P3 Study is a United States post market study to gather data on clinical status, primary indications, device therapy choices, clinical management and outcomes for patients with implantable pacemakers.
Interventions
None listed
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient meets Class I / Class II indications for pacing * Patient implanted with one of the following market-approved single or dual chamber Medtronic devices: EnRhythm™, EnPulse®, Kappa® 700, Kappa® 900, Vitatron Clarity™, Vitatron Selection® AFm, Vitatron C-Series, Vitatron T-Series, or the AT500™ DDDR Pacing System
Exclusion criteria
* Patient is enrolled in a device or cardiovascular drug study that affects treatment and/or study device programming * Patient whose life expectancy is less than two years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Dual Chamber Devices | at original implant | Pacemaker device choice characterized by the number of patients with dual chamber devices |
| Days Hospitalized | implant to one year | Healthcare utilization clinical outcome characterized by number of days hospitalized in the first year |
| Multiple In-clinic Visits | implant to one year | Follow-up practice pattern assessed by the number of patients with a dual chamber device that had two or more routine pacemaker in-clinic visits with a device interrogation |
Countries
United States
Participant flow
Recruitment details
Patients were enrolled in the study from March 2004 through April 2006.
Pre-assignment details
Only patients who received an approved study device were enrolled in the registry.
Participants by arm
| Arm | Count |
|---|---|
| Pacing Patients Patients implanted with a pacemaker. | 2,013 |
| Total | 2,013 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 225 |
| Overall Study | Device explanted/not replaced | 23 |
| Overall Study | Lost to Follow-up | 55 |
| Overall Study | Medical condition | 3 |
| Overall Study | Other | 59 |
| Overall Study | Physician Decision | 797 |
| Overall Study | Withdrawal by Subject | 11 |
Baseline characteristics
| Characteristic | Pacing Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1747 Participants |
| Age, Categorical Between 18 and 65 years | 266 Participants |
| Age Continuous | 76.3 years STANDARD_DEVIATION 11.2 |
| Region of Enrollment United States | 2013 participants |
| Sex: Female, Male Female | 996 Participants |
| Sex: Female, Male Male | 1017 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Days Hospitalized
Healthcare utilization clinical outcome characterized by number of days hospitalized in the first year
Time frame: implant to one year
Population: Patients with a twelve-month follow-up visit were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pacing Patients | Days Hospitalized | 0.054 average days hospitalized | Standard Deviation 2.35 |
Primary
Multiple In-clinic Visits
Follow-up practice pattern assessed by the number of patients with a dual chamber device that had two or more routine pacemaker in-clinic visits with a device interrogation
Time frame: implant to one year
Population: Only those patients with a dual chamber device completing 12 months of follow-up were included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pacing Patients | Multiple In-clinic Visits | 768 participants with 2 or more visits |
Primary
Number of Participants With Dual Chamber Devices
Pacemaker device choice characterized by the number of patients with dual chamber devices
Time frame: at original implant
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pacing Patients | Number of Participants With Dual Chamber Devices | 1684 Participants with dual chamber devices |