Trials Sponsors Conditions Drugs Pricing

Conditions

Standard Bradycardia Pacing Indication

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

Number of Subjects Programmed With Advanced Pacemaker Features
1 year
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
Number of MRI Scans by Country
1 year

Interventions

Patients implanted with a St. Jude Medical pacemakersDevice

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients with a standard bradycardia pacing indication and implanted with a St. Jude Medical pacemaker

You may qualify if:

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.

Sponsors & Collaborators

Abbott Medical Devices
Industrylead

Study Sites (4)

114 Avenue d'Arès

Bordeaux, 33074, France

Kliniken der Friedrich-Alexander-Universität

Erlangen, 91054, Germany

Via Palermo 636

Catania, 951200, Italy

2-15 Yamadaoka

Suita, 565-0871, Japan

Results Point of Contact

Title: Grant Kim
Organization: Abbott (previously St Jude Medical)

Study Officials

Grant Kim
Abbott Medical Devices
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

2,101 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Target Duration: 1 Year
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 6, 2015

First Posted

October 16, 2015

Study Start

July 2015

Date type not reported

This date has not been verified as actual or estimated.

Advanced Bradycardia Device Feature Utilization and Clinical Outcomes II

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations