Trial Outcomes & Findings for P3: Pacemaker Patient Profiling Study (NCT NCT00294060)

Results Overview

Pacemaker device choice characterized by the number of patients with dual chamber devices

Recruitment status

TERMINATED

Target enrollment

2013 participants

Primary outcome timeframe

at original implant

Results posted on

2011-05-06

Participant Flow

Patients were enrolled in the study from March 2004 through April 2006.

Only patients who received an approved study device were enrolled in the registry.

Participant milestones

Participant milestones
Measure	Pacing Patients Patients implanted with a pacemaker.
Overall Study STARTED	2013
Overall Study COMPLETED	840
Overall Study NOT COMPLETED	1173

Reasons for withdrawal

Reasons for withdrawal
Measure	Pacing Patients Patients implanted with a pacemaker.
Overall Study Death	225
Overall Study Other	59
Overall Study Lost to Follow-up	55
Overall Study Withdrawal by Subject	11
Overall Study Physician Decision	797
Overall Study Medical condition	3
Overall Study Device explanted/not replaced	23

Baseline Characteristics

P3: Pacemaker Patient Profiling Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pacing Patients n=2013 Participants Patients implanted with a pacemaker.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	266 Participants n=93 Participants
Age, Categorical >=65 years	1747 Participants n=93 Participants
Age Continuous	76.3 years STANDARD_DEVIATION 11.2 • n=93 Participants
Sex: Female, Male Female	996 Participants n=93 Participants
Sex: Female, Male Male	1017 Participants n=93 Participants
Region of Enrollment United States	2013 participants n=93 Participants

PRIMARY outcome

Timeframe: at original implant

Pacemaker device choice characterized by the number of patients with dual chamber devices

Outcome measures

Outcome measures
Measure	Pacing Patients n=2013 Participants Patients implanted with a pacemaker.
Number of Participants With Dual Chamber Devices	1684 Participants with dual chamber devices

PRIMARY outcome

Timeframe: implant to one year

Population: Patients with a twelve-month follow-up visit were included in the analysis.

Healthcare utilization clinical outcome characterized by number of days hospitalized in the first year

Outcome measures

Outcome measures
Measure	Pacing Patients n=1211 Participants Patients implanted with a pacemaker.
Days Hospitalized	0.054 average days hospitalized Standard Deviation 2.35

PRIMARY outcome

Timeframe: implant to one year

Population: Only those patients with a dual chamber device completing 12 months of follow-up were included in this analysis.

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

Outcome measures

Outcome measures
Measure	Pacing Patients n=1459 Participants Patients implanted with a pacemaker.
Multiple In-clinic Visits	768 participants with 2 or more visits

Adverse Events

Pacing Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

P3 Study Team

Medtronic CRDM

Phone: 800-328-2518

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee In most cases, contracts allow investigators to publish study results per the publication plan/protocol following Medtronic's review to determine whether confidential information ("CI") is disclosed. Any such CI is deleted prior to publication/presentation. Medtronic may not censor/interfere with the publication except as described. Investigators may not publish any single-site publications until the main multi-site study publication has occurred.
Publication restrictions are in place

Restriction type: OTHER