BRADYCARE: Advanced Bradycardia Device Feature Utilization and Clinical Outcomes

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01062126
• Collaborator: (none)
• Enrollment: 3,389
• Duration (Months): 31

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pacemaker

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

Study Design

• Study Type: Observational
• Actual Enrollment: 3389 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Advanced Bradycardia Device Feature Utilization and Clinical Outcomes
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Outcome Measures

Primary Outcome Measures

1. Complication Rate at 1-year Post-implant [12 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Study Director: Grant Kim, Abbott (previously St. Jude Medical)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT01062126
• Other Study ID Numbers: CRD525
• First Posted: Feb 4, 2010
• Last Update Posted: Oct 14, 2020
• Last Verified: Sep 1, 2020

• Keywords provided by Abbott Medical Devices: Pacemaker; Advanced Features; Clinical Outcomes
• Additional relevant MeSH terms: Bradycardia

Study Results

Participant Flow

Arm/Group Title	All Subjects Enrolled in the Study
Arm/Group Description	Patients implanted with an SJM Accent SR/DR, Accent SR/DR RF, Anthem CRT-P, Anthem CRT-P RF, or newer SJM pacemaker device
Period Title: Overall Study
STARTED	3389
COMPLETED	2856
NOT COMPLETED	533

Baseline Characteristics

Arm/Group Title	All Subjects Enrolled in the Study
Arm/Group Description	All subjects that were enrolled in the study.
Overall Participants	3389
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	559 16.5%
>=65 years	2830 83.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	74.8 (11.1)
Sex: Female, Male (Count of Participants)
Female	1546 45.6%
Male	1843 54.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	185 5.5%
Not Hispanic or Latino	3175 93.7%
Unknown or Not Reported	29 0.9%
Region of Enrollment (participants) [Number]
United States	3389 100%
Primary Indication for Pacemaker Implant (Count of Participants)
Sinus Node Dysfunction	2427 71.6%
AV Node Block	754 22.2%
Syncope	220 6.5%
Pacemaker Replacement	329 9.7%
PAVE	55 1.6%
Others	20 0.6%
Cardiovascular History (Count of Participants)
Coronary Artery Disease	1361 40.2%
Angina	156 4.6%
Myocardial Infarction	204 6%
Heart Failure	25 0.7%
Hypertension	2668 78.7%
Ejection Fraction (% of blood leaving heart at contraction) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [% of blood leaving heart at contraction]	56.8 (9.9)
Other Medical History (Count of Participants)
Pulmonary disease	335 9.9%
Hepatic/Renal disease	306 9%
Diabetes	869 25.6%
Peripheral vascular disease	240 7.1%
Medications (Count of Participants)
ACE Inhibitors/ARBs	1659 49%
Aldosterone inhibitors	64 1.9%
Anti-coagulants	1064 31.4%
Antiarrhythmics - Class I	103 3%
Antiarrhythmics - Class III	356 10.5%
Antiplatelet	1833 54.1%
Beta Blockers	1653 48.8%
Calcium channel blockers	936 27.6%
Cardiac glycosides	239 7.1%
Diuretics	1172 34.6%
Nitrates	360 10.6%
Other cardiac	351 10.4%
Positive Ionotropics	11 0.3%
Statins	150 4.4%
Systolic BP (mm Hg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm Hg]	130.1 (19.6)
Diastolic BP (mm Hg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm Hg]	72.2 (11.3)
Heart Rate (beats per min (bpm)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [beats per min (bpm)]	69.4 (12.1)

Outcome Measures

1. Primary Outcome

Title	Complication Rate at 1-year Post-implant
Description	Complication rate and 95% confidence interval at 1-year post-implant
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All subjects enrolled in the study.

Arm/Group Title	All Subjects Enrolled in the Study
Arm/Group Description	All subjects that were enrolled in the study.
Measure Participants	3389
Number (95% Confidence Interval) [percentage of enrolled subjects]	1.12

Adverse Events

Time Frame	Adverse events reported during the 1-year study.
Arm/Group Title	All Subjects Enrolled in the Study
Arm/Group Description	All subjects that were enrolled in the study.
All Cause Mortality
	All Subjects Enrolled in the Study
	Affected / at Risk (%)	# Events
Total	209/3389 (6.2%)
Serious Adverse Events
	All Subjects Enrolled in the Study
	Affected / at Risk (%)	# Events
Total	38/3389 (1.1%)
Cardiac disorders
Atrial Fibrillation	1/3389 (0%)	1
Gastrointestinal disorders
Bleeding/Hematoma	1/3389 (0%)	1
Infections and infestations
Infection	6/3389 (0.2%)	6
Injury, poisoning and procedural complications
Dehisence	1/3389 (0%)	1
Mid-sternal pain at the location of RA and RV leads	2/3389 (0.1%)	2
Open wound at PG incision site	1/3389 (0%)	1
Pericardial effusion	2/3389 (0.1%)	2
Pericardial tamponade	1/3389 (0%)	1
Pocket Revision- not Healing	1/3389 (0%)	1
Set Screw not secured at Implant	1/3389 (0%)	1
Product Issues
Lead dislodgement or migration	14/3389 (0.4%)	15
Elevated pacing thresholds	3/3389 (0.1%)	3
Diaphragmatic/Phrenic Nerve Stimulation	1/3389 (0%)	1
Lead Malfunction	1/3389 (0%)	1
Lead fracture	4/3389 (0.1%)	4
Loss of capture	1/3389 (0%)	1
Oversensing	1/3389 (0%)	1
Other (Not Including Serious) Adverse Events
	All Subjects Enrolled in the Study
	Affected / at Risk (%)	# Events
Total	17/3389 (0.5%)
Cardiac disorders
Atrial Arrhythmia	2/3389 (0.1%)	2
Product Issues
Elevated pacing thresholds	6/3389 (0.2%)	6
Oversensing	3/3389 (0.1%)	3
Inappropriate device interaction	2/3389 (0.1%)	2
Loss of capture	2/3389 (0.1%)	2
Vascular disorders
Syncope	2/3389 (0.1%)	2
Hematoma	3/3389 (0.1%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.