Primary objective 1To quantify the 24-hour AF burden accuracy in patients with more than 1% AF burden. Primary objective 2To quantify the detection accuracy of non-arrhythmia in patients with 1% or less AF burden.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is:
- the AF burden determined from the subcutaneous ECG.
Secondary endpoints are:
- R-wave sensing performance parameters, AF performance parameters, and
adverse events.
Secondary outcome
Secondary endpoints are:
- R-wave sensing performance parameters,
- AF performance parameters,
- and adverse events.
Background summary
The study will demonstrate the AF burden accuracy of the Reveal® XT, compared
to 2-day Holter recordings. The correct detection of non-arrhythmia segments
(specificity) is equally important clinically and will also be quantified. In
addition, the R-wave sensing performance and the overall system performance
will be quantified, user feedback obtained, and device safety data collected.
Two patient groups will be enrolled in the study. The first eligible patient
group will have had or be scheduled for pulmonary vein ablation or surgical
rhythm control intervention. Long term continuous arrhythmia monitoring is
expected to disclose AF recurrences post AF ablation and be helpful in making
informed therapeutic decisions in these patients.
The second eligible patient group will be patients with difficult to treat
paroxysmal AF with frequent symptoms. Arrhythmia monitoring is expected to
reveal the true AF burden for therapy management in this group.
Study objective
Primary objective 1
To quantify the 24-hour AF burden accuracy in patients with more than 1% AF
burden.
Primary objective 2
To quantify the detection accuracy of non-arrhythmia in patients with 1% or
less AF burden.
Study design
The study is a prospective, non-randomized, multi-center international
post-market study.
The primary study objectives will be assessed using a continuous recording of
the subcutaneous ECG and the marker channel from the Reveal® XT, which are
uplinked to the Holter and stored on the Holter*s memory card synchronously
with a conventional surface ECG. The Reveal® XT can be programmed to
continuously upload the subcutaneous ECG and the marker channel for up to 46
hours.
Study burden and risks
5.2.1 Potential risks and discomforts
The implantation of the Reveal® XT device is not part of the study. Standard
risks associated with the medical device are listed in the Reveal® XT 9529
Clinician Manual. This study is considered to entail minimal risk. The
potential risks to a subject are expected to be the same as those encountered
during standard ECG testing or Holter recording. Therefore the risks involved
include but are not limited to irritation of the skin or an allergic reaction
to the ECG electrodes or the adhesive plaster or tape used to secure the
electrodes or leads to the skin.
There may be additional risks related to study participation that are unknown
at this time.To minimize the risks, the center personnel will be well trained
on the study procedures and the patients will be closely observed and monitored
during the study visits.
5.2.2 Potential benefits
There are no direct personal benefits for participating subjects.
Participation in the study will contribute to a better understanding of the
performance of a new medical device, which will be important for future
developments and future treatments.
P.O. Box 5227
6802 EE
Nederland
P.O. Box 5227
6802 EE
Nederland
Listed location countries
Age
Inclusion criteria
• Patient is willing and able to provide his/her informed consent
• Patient has been implanted with a Reveal® XT
• Patient fulfills at least one of the following three additional requirements
1. is scheduled for PV ablation or surgical rhythm control intervention, and the
PV ablation or surgical intervention can be deferred until study completion or
2. has documented frequent AF or frequent symptoms attributable to AF or
3. has undergone PV ablation within the last 6 months and still has symptoms
attributable to AF
Exclusion criteria
- Patient has an implanted pacemaker or ICD
- Patient has persistent or permanent AF
- Patient is allergic to adhesive ECG electrodes
- The study will interfere with a therapeutic or diagnostic procedure which is
planned or expected during the study period
- Patient is participating in another study that is expected to compromise the
results of this study
- Patient is a minor, legally incompetent, or does not meet other local requirements
for participation in a clinical study
- Patient is pregnant
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 |
|---|---|
| CCMO | NL18217.094.07 |