P3: Pacemaker Patient Profiling Study

Medtronic

Status: Terminated

Conditions: Bradycardia

Study type: Observational

Funder types: Industry

Identifiers

NCT00294060

244

Details and patient eligibility

About

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.

Enrollment: 2,013 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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