Clinical trial NCT01062126: BRADYCARE: Advanced Bradycardia Device Feature Utilization and Clinical Outcomes
Official title: Advanced Bradycardia Device Feature Utilization and Clinical Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pacemaker
Keywords: Pacemaker
Advanced Features
Clinical Outcomes
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2010-02-04
Enrollment: 3389
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients indicated for standard Pacemaker indications

Brief summary: Pacemaker technology is constantly evolving. In the past 10 years, numerous advancements have been made in pacemaker therapy, diagnostics and connectivity. These advancements include automated capture, automated sensing, patient alert functions, algorithms minimizing ventricular pacing, automatic mode switching in response to atrial tachyarrhythmia, rate responsive pacing, advanced diagnostic features, remote monitoring and radiofrequency (RF) technology. However, little information is available on how these new features are being utilized by physicians in the real world and how these features impact patient outcomes.

This observational study will gather data on the patients' presenting clinical status, indication for device implantation, utilization of advanced device features, device therapy choices, clinical management and outcomes in a general pacemaker population.

The primary aim of the study is to evaluate the usage of advanced features and diagnostics in patients with St. Jude Medical pacemakers. The secondary aim of the study is to learn more about the progressive clinical outcomes in the general pacemaker patient population. The tertiary aim of the study is to evaluate the correlation between the usage of advanced features in pacemaker patients and the patient's clinical outcomes.

Detailed description: Evaluation of Device Features and Diagnostics

* Programmed parameters: Advanced pacemaker features (Autocapture, Auto sensitivity control (ASC), Ventricular Intrinsic Preference (VIP®), Patient Notifier, RF telemetry, and newer advanced features)
* Device and lead measurements
* Number of AT/AF, VT/VF, PMT and AMS episodes

Evaluation of Clinical Parameters

* Indication for device implantation
* Cardiac and arrhythmia history
* Cardiac drug utilization
* Cardiac events: incidence and onset of symptomatic atrial fibrillation (AF), onset of heart failure (HF), incidence and onset of angina, occurrence of myocardial infarction (MI), occurrence of transient ischemic attack (TIA)/ischemic stroke, and occurrence of hemorrhagic stroke
* Modified Specific Activity Scale (SAS)
* Intrinsic QRS duration
* Left ventricular ejection fraction (LVEF)
* Adverse events
* All-cause, cardiovascular and heart failure hospitalizations
* All-cause, cardiovascular and heart failure mortality

Eligibility criteria: Inclusion Criteria:

* Patient has a current indication for a single-chamber (SR) or dual-chamber (DR) pacemaker or CRT-P device.
* Patient is implanted with an SJM Accent™ SR/DR, Accent™ SR/DR RF, Anthem™ CRT-P, Anthem™ CRT-P RF, or newer SJM pacemaker device.
* Patient is geographically stable and willing to comply with the required follow-up schedule.
* Patient is not pregnant or planning to become pregnant.
* Patient is \>18 years of age.

Exclusion Criteria:

* Patient's life expectancy is less than 12 months.

Primary outcomes:
measure: Complication Rate at 1-year Post-implant
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Abbott (previously St. Jude Medical)
name: Grant Kim
role: STUDY_DIRECTOR
References: