Arrhythmias, Cardiac
Conditions
Brief summary
The purpose of this study is to gather evidence about the safety and feasibility of performing the implant procedure for the Reveal Insertable Cardiac Monitor (ICM) in an office or clinic setting rather than the traditional hospital operating room, cardiac catheterization or electrophysiology (EP) laboratory setting.
Interventions
DEVICEReveal® DX or Reveal® XT Insertable Cardiac Monitor
Reveal® DX and Reveal® XT Insertable Cardiac Monitors are implantable patient-activated and automatically-activated monitoring systems that record subcutaneous ECG.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is indicated for continuous arrhythmia monitoring with an Insertable Cardiac Monitor (ICM) * Patient is willing to undergo implant in clinic setting with only local anesthetic and/or oral anti-anxiety medications for sedation * 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 including the required follow-up
Exclusion criteria
* Patient has reduced immune function or is otherwise at high risk for infection * Patient has had a recent (within 30 days) or otherwise unresolved infection * Patient is implanted or indicated for implant with a pacemaker, Implantable Cardioverter-Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT), or hemodynamic monitoring system * Patient is participating in another clinical study that may have an impact on the study endpoints * Patient's life expectancy is less than 1 year * Patient is pregnant * Patient has unusual thoracic anatomy or scarring at the implant site which may adversely affect the success of the implant procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure-related Complications Rate Requiring Resolution by Surgical Intervention | From Implant to 90 days post-implant procedure | This objective estimates the proportion of patients having procedure-related complication requiring resolution by surgical intervention at 90 days post-implant procedure using Kaplan-Meier method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Having Procedure-related Adverse Events | From Implant to 90 days post-implant procedure | Report number of participants having procedure-related adverse events that meet the primary endpoint (requiring surgical intervention), and number of participants having other procedure-related adverse events (not requiring surgical intervention). |
| Surgical Staff Utilized for Reveal In-office Implants | At implant | Observational analysis of surgical staff present at the Reveal Implants |
| Techniques and Procedures Utilized During Reveal In-office Implants | At implant | Observational data collection as to the technics and procedures utilized during all implants including (but not limited to): device orientation, suturing, wound closure, instrument and material use, and time. |
| Physician Satisfaction With Reveal In-office Implants | At implant | Observational survey of physicians satisfaction post implant At implant |
| R-wave Amplitude Measurement | Implant procedure and 30 days post-implant procedure | Average R-wave amplitude at implant and 30-days post procedure |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enrollment Cohort Enrollment cohort includes any patients who meet the inclusion and exclusion criteria and have a signed inform consent. | 66 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Patient exited prior to implant | 1 |
Baseline characteristics
| Characteristic | Enrollment Cohort |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 25 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants |
| Age, Continuous | 59.9 years STANDARD_DEVIATION 17.98 |
| Region of Enrollment United States | 66 participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 65 |
| serious Total, serious adverse events | 0 / 65 |
Outcome results
Primary
Procedure-related Complications Rate Requiring Resolution by Surgical Intervention
This objective estimates the proportion of patients having procedure-related complication requiring resolution by surgical intervention at 90 days post-implant procedure using Kaplan-Meier method.
Time frame: From Implant to 90 days post-implant procedure
Population: Reveal device indicated patients, enrolled in the study and implanted per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Implant Cohort | Procedure-related Complications Rate Requiring Resolution by Surgical Intervention | 2 participants |
Secondary
Number of Participants Having Procedure-related Adverse Events
Report number of participants having procedure-related adverse events that meet the primary endpoint (requiring surgical intervention), and number of participants having other procedure-related adverse events (not requiring surgical intervention).
Time frame: From Implant to 90 days post-implant procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Implant Cohort | Number of Participants Having Procedure-related Adverse Events | AEs that meet the primary endpoint | 2 participants |
| Implant Cohort | Number of Participants Having Procedure-related Adverse Events | Other procedure-related AEs | 4 participants |
Secondary
Physician Satisfaction With Reveal In-office Implants
Observational survey of physicians satisfaction post implant At implant
Time frame: At implant
Secondary
R-wave Amplitude Measurement
Average R-wave amplitude at implant and 30-days post procedure
Time frame: Implant procedure and 30 days post-implant procedure
Secondary
Surgical Staff Utilized for Reveal In-office Implants
Observational analysis of surgical staff present at the Reveal Implants
Time frame: At implant
Secondary
Techniques and Procedures Utilized During Reveal In-office Implants
Observational data collection as to the technics and procedures utilized during all implants including (but not limited to): device orientation, suturing, wound closure, instrument and material use, and time.
Time frame: At implant