Arrhythmia Type Unknown
Conditions
Brief summary
The purpose of the Medtronic SEEQ™ Performance study is to build further evidence on the clinical and economic benefit of the Medtronic market-released SEEQ™ Mobile Cardiac Telemetry System/External Cardiac Monitor System (MCT/ECM).
Interventions
None listed
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is indicated for a SEEQ™ MCT/ECM System for approved indications * Patient is 18 years of age or older * Patient is willing and able to provide consent and authorize the use and disclosure of health information * Patient is willing and able to comply with the protocol
Exclusion criteria
* Patient has known allergy and/or hypersensitivity to adhesives or hydrogel. * Patient has suspected potential life-threatening arrhythmias, or requires in-subject/in-hospital monitoring. * Patient will undergo a medical procedure that would preclude full participate during the prescribed duration of the SEEQ™ * Patient has an implanted cardiac device, (e.g., pacemaker, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic Yield of the SEEQ™ MCT/ECM System | 120 Days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SEEQ™ MCT/ECM System SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias. | 200 |
| Total | 200 |
Baseline characteristics
| Characteristic | SEEQ™ MCT/ECM System |
|---|---|
| Age, Continuous | 73.6 years STANDARD_DEVIATION 11.1 |
| Region of Enrollment United States | 200 participants |
| Sex: Female, Male Female | 109 Participants |
| Sex: Female, Male Male | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 63 / 182 |
| serious Total, serious adverse events | 0 / 182 |
Outcome results
Primary
Diagnostic Yield of the SEEQ™ MCT/ECM System
Time frame: 120 Days
Population: Subjects prescribed the SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SEEQ™ MCT/ECM System | Diagnostic Yield of the SEEQ™ MCT/ECM System | 85.7 percentage of subjects with CRA |