Reveal® DX or Reveal® XT Insertable Cardiac Monitor
DeviceReveal® DX and Reveal® XT Insertable Cardiac Monitors are implantable patient-activated and automatically-activated monitoring systems that record subcutaneous ECG.
NCT Number: NCT01168427
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
La Jolla, California, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Reveal® DX and Reveal® XT Insertable Cardiac Monitors are implantable patient-activated and automatically-activated monitoring systems that record subcutaneous ECG.
Time frame: 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.
Time frame: 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).
Time frame: At implant
Observational analysis of surgical staff present at the Reveal Implants
Time frame: 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.
Time frame: At implant
Observational survey of physicians satisfaction post implant At implant
Time frame: Implant procedure and 30 days post-implant procedure
Average R-wave amplitude at implant and 30-days post procedure
Medtronic Cardiac Rhythm and Heart Failure
Industry
Reveal® In-Office Implants Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04869527
Arrhythmias, Cardiac, Cardiovascular Diseases
Porto Alegre, Rio Grande do Sul, Brazil
View Trial DetailsNCT06890208
Anxiety Disorders, Arrhythmias, Cardiac
Hamburg, Germany
View Trial DetailsNCT06939478
Arrhythmias, Cardiac, Cardiovascular Diseases
Birmingham, Alabama, United States
View Trial DetailsNCT04876963
Arrhythmias, Cardiac, Cardiovascular Diseases
Copenhagen, Denmark
View Trial Details