BRADYCARE: Advanced Bradycardia Device Feature Utilization and Clinical Outcomes

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.

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Key information

Conditions

Pacemaker

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Complication Rate at 1-year Post-implant

Time frame: 12 months

Complication rate and 95% confidence interval at 1-year post-implant

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Advanced Bradycardia Device Feature Utilization and Clinical Outcomes

Acronym: BRADYCARE

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Feb 4, 2010
Registry last updated: Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed