BRADYCARE: Advanced Bradycardia Device Feature Utilization & Clinical

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01062126
Study type	Observational
Source	Abbott Medical Devices
Contact
Status	Completed
Phase
Start date	February 2010
Completion date	September 2012

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

BRADYCARE: Advanced Bradycardia Device Feature Utilization and Clinical Outcomes — BRADYCARE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms