Heart Failure, Cardiac Arrhythmia
Conditions
Keywords
utility of MediGuide system, CRT, EP
Brief summary
The goal of this registry/observational study is to collect data on the clinical utility of MediGuide™ system in cardiac resynchronization therapy (CRT) implantation and electrophysiology (EP) procedures.
Detailed description
The intent of this worldwide registry/observational study is to understand the utility of the MediGuide™ technology in real world clinical practice during CRT implantation and study-specific-EP procedures. The study should provide an understanding of the effect of MediGuide™ technology on: * The amount of fluoroscopy time and the radiation exposure * Total procedure time * Peri-procedural clinical event rate Additionally, this study will address the following * Identification of procedural challenges which may aid in developing future MediGuide tools * Evaluation of newly available MediGuide tools during the study * Correlation between MediGuide operator experience and the radiation exposure amount and time
Interventions
PROCEDURECRT implantation
It is a novel 3D electromagnetic navigation system (MediGuide™) that is capable of non-fluoroscopic navigation of sensor-enabled tools in the x-ray environment
DEVICEMediGuide
PROCEDUREEP
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Anybody coming for CRT or EP procedure utilizing MediGuide system and tools
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Fluoroscopy Time | Expected time frame is day 1 of the study | Amount of fluoroscopy time during CRT implant or EP procedure |
| Periprocedural Adverse Event | From the day of CRT and EP procedure until patient discharge, expected stay is an average of 3 days | Adverse event until patients are discharged from the site center |
Countries
Australia, Austria, Canada, Estonia, Germany, Netherlands, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CRT Group All subjects willing to provide written informed consent from participating sites, who were indicated for a CRT-D/P device implant (including an upgrade with a new LV lead) and were implanted with a SJM pulse generator, utilizing the MediGuide system and tools, were enrolled in this registry. Subjects could be implanted with non-SJM leads. | 147 |
| EP Group All subjects willing to provide written informed consent from participating sites, who were undergoing ablation procedures for atrial fibrillation, atrial flutter and ventricular tachycardia, utilizing the MediGuide system and tools, were enrolled in this registry. | 431 |
| Total | 578 |
Baseline characteristics
| Characteristic | Total | EP Group | CRT Group |
|---|---|---|---|
| Age, Continuous | 64.6 years STANDARD_DEVIATION 12.5 | 62.5 years STANDARD_DEVIATION 12.5 | 70.8 years STANDARD_DEVIATION 10.3 |
| LEFT VENTRICULAR EJECTION FRACTION | 48.0 PERCENTAGE STANDARD_DEVIATION 16.1 | 55.1 PERCENTAGE STANDARD_DEVIATION 11.5 | 29.1 PERCENTAGE STANDARD_DEVIATION 10.2 |
| NYHA classification NOT AVAILABLE | 210 Participants | 178 Participants | 32 Participants |
| NYHA classification NYHA I | 122 Participants | 120 Participants | 2 Participants |
| NYHA classification NYHA II | 147 Participants | 102 Participants | 45 Participants |
| NYHA classification NYHA III | 93 Participants | 27 Participants | 66 Participants |
| NYHA classification NYHA IV | 6 Participants | 4 Participants | 2 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Region of Enrollment Australia | 26 participants | 26 participants | 0 participants |
| Region of Enrollment Austria | 11 participants | 11 participants | 0 participants |
| Region of Enrollment Canada | 64 participants | 28 participants | 36 participants |
| Region of Enrollment Estonia | 52 participants | 27 participants | 25 participants |
| Region of Enrollment Germany | 139 participants | 132 participants | 7 participants |
| Region of Enrollment Italy | 5 participants | 3 participants | 2 participants |
| Region of Enrollment Netherlands | 16 participants | 16 participants | 0 participants |
| Region of Enrollment Spain | 46 participants | 46 participants | 0 participants |
| Region of Enrollment Taiwan | 10 participants | 10 participants | 0 participants |
| Region of Enrollment United States | 162 participants | 90 participants | 72 participants |
| Sex: Female, Male Female | 171 Participants | 129 Participants | 42 Participants |
| Sex: Female, Male Male | 407 Participants | 302 Participants | 105 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 142 | 0 / 419 |
| other Total, other adverse events | 0 / 142 | 11 / 11 |
| serious Total, serious adverse events | 5 / 142 | 12 / 419 |
Outcome results
Primary
Amount of Fluoroscopy Time
Amount of fluoroscopy time during CRT implant or EP procedure
Time frame: Expected time frame is day 1 of the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CRT Group | Amount of Fluoroscopy Time | 9.5 MINUTES | Standard Deviation 8 |
| EP Group | Amount of Fluoroscopy Time | 6.0 MINUTES | Standard Deviation 9.9 |
Primary
Periprocedural Adverse Event
Adverse event until patients are discharged from the site center
Time frame: From the day of CRT and EP procedure until patient discharge, expected stay is an average of 3 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CRT Group | Periprocedural Adverse Event | 6 ADVERSE EVENTS |
| EP Group | Periprocedural Adverse Event | 12 ADVERSE EVENTS |