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

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02577887
• Collaborator: (none)
• Enrollment: 2,101
• Locations: 4
• Duration (Months): 29.5
• Patients Per Site: 525.3
• Patients Per Site Per Month: 17.8

Study Details

Study Description

Brief Summary

The purpose of this study is to characterize the utilization of diagnostics capabilities in St. Jude Medical pacemakers to manage patients with a standard bradycardia pacing indication.

Condition or Disease	Intervention/Treatment	Phase
Standard Bradycardia Pacing Indication	Device: Patients implanted with a St. Jude Medical pacemakers

Detailed Description

The study is a prospective, non-randomized, multi-center observational study designed to evaluate the utilization of diagnostic capabilities, indications, MRI scanning capabilities and clinical outcomes of patients implanted with SJM pacemakers.

The total duration of the study is expected to be approximately 30 months. The clinical study will be conducted in up to 160 centers across Europe, Middle East, Africa, (EMEA region) and Asia, Australia and New Zealand (Asia-Pac region). Approximately 2016 subjects will be enrolled in this study. Subjects will be followed for 1 year after pacemaker implant.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 2101 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Advanced Bradycardia Device Feature Utilization and Clinical Outcomes II
• Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Nov 25, 2017
• Actual Study Completion Date: Dec 15, 2017

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Complications in the General Pacemaker Population [1 year]

   The rate of device related adverse events that require a medical intervention and/or hospitalization for treatment.

Secondary Outcome Measures

1. Number of Subjects Programmed With Advanced Pacemaker Features [1 year]

   Advanced pacemaker features include Autocapture, Auto sensitivity control (ASC), Ventricular Intrinsic Preference (VIP®), Patient Notifier, RF telemetry, and newer advanced features.

2. Number of Pacemaker Patients With Atrial Tachycardia/Fibrillation (AT/AF), Ventricular Tachycardia/Fibrillation (VT/VF), Pacemaker-mediated Tachycardia (PMT) and Automatic Mode Switching (AMS) Episodes [1 year]

   At each follow-up, devices were interrogated and device session records were uploaded. Episodes of AT/AF, VT/VF, PMT and AMS were measured by the pacemakers diagnostics features.

3. Number of MRI Scans by Country [1 year]

   The total number of scans performed by country

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients who have been implanted with an SJM Assurity MRI™, Endurity MRI™ or other SJM MRI compatible pacemakers in the EMEA region within 30 days or patients implanted with an Accent MRI™, Assurity MRI™, Endurity MRI™ or other SJM MRI compatible pacemakers in the Asia-Pac region within 30 days.

• Patient is geographically stable and willing to comply with the required follow-up schedule.

• Patient is not pregnant or planning to become pregnant during the course of the study.

• Patient is > 18 years of age

Exclusion Criteria:

• Patient's life expectancy is less than 1 year

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	114 Avenue d'Arès	Bordeaux		France	33074
2	Kliniken der Friedrich-Alexander-Universität	Erlangen		Germany	91054
3	Via Palermo 636	Catania		Italy	951200
4	2-15 Yamadaoka	Suita		Japan	565-0871

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Study Director: Grant Kim, Abbott Medical Devices

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 28, 2015

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT02577887
• Other Study ID Numbers: SJM-CIP-10073
• First Posted: Oct 16, 2015
• Last Update Posted: Mar 9, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Bradycardia

Study Results

Participant Flow

Arm/Group Title	All Consented Patients
Arm/Group Description	Patients implanted with Accent MRI, Assurity MRI, Endurity MRI or other newer SJM pacemakers, with a standard indication for implant.
Period Title: Overall Study
STARTED	2101
6 Month Follow-up	1938
COMPLETED	1803
NOT COMPLETED	298

Baseline Characteristics

Arm/Group Title	All Consented Patients
Arm/Group Description	Patients implanted with Accent MRI, Assurity MRI, Endurity MRI or other newer SJM pacemakers, with a standard indication for implant.
Overall Participants	2101
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	74.5 (10.6)
Sex: Female, Male (Count of Participants)
Female	896 42.6%
Male	1205 57.4%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Count of Participants)
Japan	234 11.1%
Italy	178 8.5%
France	241 11.5%
Germany	236 11.2%
Austria	96 4.6%
Belgium	64 3%
China	48 2.3%
Estonia	183 8.7%
Finland	92 4.4%
Hong Kong	10 0.5%
India	56 2.7%
Lithuania	46 2.2%
Netherlands	131 6.2%
Portugal	102 4.9%
South Korea	155 7.4%
Spain	157 7.5%
United Kingdom	72 3.4%
Primary Indication (Count of Participants)
Sinus Node Dysfunction	868 41.3%
AV Node Block	1026 48.8%
Syncope	189 9%
Prevention/Termination of Tachyarrhythmias by Paci	16 0.8%
Pacemaker replacement	2 0.1%
Cardiovascular History (Count of Participants)
Angina	62 3%
Cardiomyopathy	438 20.8%
Coronary Artery Disease	452 21.5%
Heart Failure	4 0.2%
Hypertension	1371 65.3%
Myocardial infarction	182 8.7%
Medication (Count of Participants)
ACE Inhibitors/ ARBs	1124 53.5%
Aldosterone Inhibitors	85 4%
Anti-Coagulants	679 32.3%
Antiarrhythmics- Class I	82 3.9%
Antiarrhythmics- Class III	98 4.7%
Antiplatelet	665 31.7%
Beta Blockers	711 33.8%
Calcium Channel Blockers	612 29.1%
Cardiac Glycosides	46 2.2%
Diuretics	730 34.7%
Nitrates	109 5.2%
Other Cardiac	96 4.6%
Positive Inotropics	3 0.1%
Statins	154 7.3%
Blood Pressure (mm Hg) (mm Hg) [Mean (Standard Deviation) ]
Diastolic Blood Pressure	74.8 (12.2)
Systolic Blood Pressure	138.3 (21.9)
Ejection Fraction (%) (% of blood leaving heart at contraction) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [% of blood leaving heart at contraction]	59.6 (9.4)
Heart Rate (bpm) (bpm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [bpm]	64.2 (16.4)
Other Medical History (Count of Participants)
Diabetes	509 24.2%
Heaptic/Renal disease	253 12%
Peripheral vascular disease	90 4.3%
Pulmonary disease	89 4.2%
Smoking	634 30.2%
Stroke	216 10.3%
Cardiovascular Interventions (Count of Participants)
Ablation	3 0.1%
Coronary Artery Bypass Grafting (CABG)	113 5.4%
Perc Coronary Intervention (PCI )/ Atherectomy	251 11.9%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Complications in the General Pacemaker Population
Description	The rate of device related adverse events that require a medical intervention and/or hospitalization for treatment.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

All subjects.

Arm/Group Title	All Consented Patients
Arm/Group Description	Patients implanted with Accent MRI, Assurity MRI, Endurity MRI or other newer SJM pacemakers, with a standard indication for implant.
Measure Participants	2101
Number (95% Confidence Interval) [percentage of subjects]	3.33

2. Secondary Outcome

Title	Number of Subjects Programmed With Advanced Pacemaker Features
Description	Advanced pacemaker features include Autocapture, Auto sensitivity control (ASC), Ventricular Intrinsic Preference (VIP®), Patient Notifier, RF telemetry, and newer advanced features.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

All study participants that completed that 12-month visit and had the feature enabled for the duration of the study. Subjects that had a change in the status of the feature (e.g. ON to OFF) are not included in the count shown here.

Arm/Group Title	All Consented Patients
Arm/Group Description	Patients implanted with Accent MRI, Assurity MRI, Endurity MRI or other newer SJM pacemakers, with a standard indication for implant.
Measure Participants	1803
Ventricular Intrinsic Preference	732 34.8%
AF Suppression	10 0.5%
Trigger Alert: High RV Rate	1738 82.7%
Trigger Alert: High V Rate during AT/AF	1439 68.5%
Trigger Alert: AT/AF	1432 68.2%
Trigger Alert: Exceeded AT/AF Burden	1433 68.2%
Trigger Alert: % V Pace	1280 60.9%
Trigger Alert: Atrial Impedance Out of Range	34 1.6%
Trigger Alert: Ventricular Impedance Out of Range	37 1.8%
Remote Monitoring	198 9.4%
Atrial Capture Confirm	245 11.7%
Right Ventricular Auto Capture	678 32.3%
Atrial Pace during PMT	1412 67.2%

3. Secondary Outcome

Title	Number of Pacemaker Patients With Atrial Tachycardia/Fibrillation (AT/AF), Ventricular Tachycardia/Fibrillation (VT/VF), Pacemaker-mediated Tachycardia (PMT) and Automatic Mode Switching (AMS) Episodes
Description	At each follow-up, devices were interrogated and device session records were uploaded. Episodes of AT/AF, VT/VF, PMT and AMS were measured by the pacemakers diagnostics features.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

All patients that completed the 12-month follow-up visit.

Arm/Group Title	All Consented Patients
Arm/Group Description	Patients implanted with Accent MRI, Assurity MRI, Endurity MRI or other newer SJM pacemakers, with a standard indication for implant.
Measure Participants	1803
Number of subjects with PMT	563 26.8%
Number of subjects with AT/AF	427 20.3%
Number of subjects with VT/VF	861 41%

4. Secondary Outcome

Title	Number of MRI Scans by Country
Description	The total number of scans performed by country
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

All study participants

Arm/Group Title	All Consented Patients
Arm/Group Description	Patients implanted with Accent MRI, Assurity MRI, Endurity MRI or other newer SJM pacemakers, with a standard indication for implant.
Measure Participants	2101
Estonia	34
Italy	14
Germany	13
Japan	13
France	10
Belgium	7
Austria	6
Netherland	5
Spain	4
South Korea	4
Finland	2
UK	2
Portugal	2

Adverse Events

Time Frame	1 year
Arm/Group Title	All Consented Patients
Arm/Group Description	Patients implanted with Accent MRI, Assurity MRI, Endurity MRI or other newer SJM pacemakers, with a standard indication for implant.
All Cause Mortality
	All Consented Patients
	Affected / at Risk (%)	# Events
Total	94/2101 (4.5%)
Serious Adverse Events
	All Consented Patients
	Affected / at Risk (%)	# Events
Total	70/2101 (3.3%)
Cardiac disorders
Arrhythmia	2/2101 (0.1%)	2
Cardiac Arrest	2/2101 (0.1%)	2
Cardiac Tamponade	2/2101 (0.1%)	2
Endocarditis	2/2101 (0.1%)	2
Pericarditis associated with Dressler's Syndrome	1/2101 (0%)	1
General disorders
Unknown Death	6/2101 (0.3%)	6
Immune system disorders
Inflammatory Allergic Reaction	1/2101 (0%)	1
Infections and infestations
Infection	1/2101 (0%)	1
Injury, poisoning and procedural complications
Cardiac Perforation	4/2101 (0.2%)	4
Device Migration	1/2101 (0%)	1
Lead Misplacement	1/2101 (0%)	1
Pocket Erosion	1/2101 (0%)	1
Investigations
Reduction of LVEF due to RV Pacing	1/2101 (0%)	1
Nervous system disorders
TIA	2/2101 (0.1%)	2
Stroke	1/2101 (0%)	1
Product Issues
Loss of Normal Desired Pacing and/or Sensing due to Lead Displacement	25/2101 (1.2%)	26
Lead Malfunction	3/2101 (0.1%)	3
Pacemaker Mediated Tachycardia	2/2101 (0.1%)	2
Loss of Normal Device Function due to Battery Failure or Component Malfunction	1/2101 (0%)	1
Threshold Elevation	1/2101 (0%)	1
Respiratory, thoracic and mediastinal disorders
Pneumothorax	9/2101 (0.4%)	9
Vascular disorders
Hematoma	4/2101 (0.2%)	4
Other (Not Including Serious) Adverse Events
	All Consented Patients
	Affected / at Risk (%)	# Events
Total	19/2101 (0.9%)
Cardiac disorders
Arrhythmia	3/2101 (0.1%)	3
General disorders
Pain at IPG Site	2/2101 (0.1%)	2
Product Issues
Lead Noise	3/2101 (0.1%)	3
Threshold Elevation	3/2101 (0.1%)	3
Extracardiac Stimulation	2/2101 (0.1%)	2
Pacemaker Mediated Tachycardia	2/2101 (0.1%)	2
Respiratory, thoracic and mediastinal disorders
Pneumothorax	2/2101 (0.1%)	2
Vascular disorders
Hematoma	5/2101 (0.2%)	5

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.