The purpose of the Confirm RxTM SMART Registry is to collect real world data to assess the safety and performance of the Confirm RxTM Insertable Cardiac Monitor (ICM) and system over a 12 month period.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary safety endpoint is the freedom from serious adverse device effects
(SADEs) and procedure related serious adverse events (SAEs) through 1 month
post insertion procedure is greater than the pre-specified performance goal.
Secondary outcome
• Freedom from device SADEs and procedure related SAEs through 12 months post
insertion procedure.
• R wave amplitude at scheduled follow-up intervals through 12 months post
insertion procedure.
Background summary
Insertable cardiac monitors (ICM) have been on the market for a while to
diagnose Complaints like syncope, dizzyness, fatique, arithmias like AF and in
case of cryptogenic stroke. The latest generation ICM has a volume which has
been reduced by 78% and is injectable. This should theoretically reduce the
infection rate.
This study will be conducted to evaluate the safety profile up to 12 months
post insertion and the clinical utility of this ICM device.
Furthermore the first 85 subjects in the study are a PMCF requirement.
Study objective
The purpose of the Confirm RxTM SMART Registry is to collect real world data to
assess the safety and performance of the Confirm RxTM Insertable Cardiac
Monitor (ICM) and system over a 12 month period.
Study design
This is a prospective, single arm, multi-center registry study of subjects with
a Confirm Rx* ICM device inserted
Study burden and risks
There is no additional risk in participating in the study. The burden consists
of filling out different questionnaires at baseline and the 1 and 12 month
follow up visits.
For subjects who participate in the Holter substudy the burden consists of
wearing the Holter device for 4 days.
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Listed location countries
Age
Inclusion criteria
• Have an approved indication for continuous arrhythmia monitoring with an ICM.
• Have a cellular phone or the ability or willing to use a St. Jude Medical
mobile transmitter that is compatible with the MyMerlin* App and able to
communicate with the Confirm RxTM ICM device. If a subject doesn*t have a cell
phone or loses their cell phone, then the site can provide a St. Jude Medical
mobile transmitter to the subject. The study will not provide cell phones.
• Have the ability to provide informed consent for study participation and be
willing and able to comply with the prescribed follow-up tests and schedule of
evaluations.
• Are 18 years of age or older, or of legal age to give informed consent
specific to state and national law.
Exclusion criteria
• Subject is implanted with or indicated for implant with a pacemaker,
implantable cardioverter defibrillator (ICD), or cardiac resynchronization
therapy (CRT) device.
• Enrolled or intend to participate in a clinical drug and/or device study,
which could confound the results of this trial as determined by the sponsor,
during the course of this clinical study.
• Have a life expectancy of less than 1 year due to any condition.
• Have a previous ICM placement.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03505801 |
| CCMO | NL65984.075.18 |