See protocol page 9This study designed to determine, via continuous monitoring with the Reveal XT implantable cardiac monitor (ICM) or newer approved version, the incidence of atrial fibrillation (AF) in patients suspected to be at high risk for…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
See protocol page 14
Primary objective
Determine the incidence rate of atrial fibrillation lasting greater than or
equal to six minutes in patients who are at high risk of having atrial
fibrillation.
Secondary outcome
See protocol page 14
Secondary objectives
* Identify predictors of AF onset in patients who are at high risk of having
atrial fibrillation.
* Characterize the timing and nature of clinical actions relative to detection
of AF in patients who are at high risk of having atrial fibrillation.
Background summary
See protocol page 9-10
Atrial fibrillation (AF) is the most common diagnosed cardiac arrhythmia. AF is
associated with significant morbidity and mortality due to cerebrovascular
complications such as stroke; which lead to a substantial economic impact on
the health care system. Therefore, the ability to
identify AF is paramount for guiding preventative therapy decisions in patients
suspected of, or who have clinical risk factors for having AF or a stroke.
However, the incidence of AF in patients suspected to be at high risk for
having AF is not known. Several aspects make AF difficult to diagnosis, such as
patient symptoms not being reliably correlated with AF episodes, the frequency
of the episodes and frequency of ECG monitoring.
Continuous cardiac monitoring may provide an important tool in both the
diagnosis and follow-up management of AF.
Study objective
See protocol page 9
This study designed to determine, via continuous monitoring with the Reveal XT
implantable cardiac monitor (ICM) or newer approved version, the incidence of
atrial fibrillation (AF) in patients suspected to be at high risk for having AF
and to understand how physicians manage these patients once AF has been
detected. Furthermore, the study will seek to identify what patient
characteristics are most predictive of developing AF. This information may
facilitate the ability to identify those patients that are at highest risk for
developing AF, and for whom Reveal ICM may be most beneficial and potentially
cost saving.
Study design
See protocol page 9
The REVEAL AF study is a prospective, single arm, open-label, multicenter,
post-market interventional clinical study. The study is expected to be
conducted at approximately 60 clinical centers located in the United States
(~45 centers) and Europe (~15 centers). Up to 450 subjects are planned to be
enrolled into the study, to have approximately 400 patients implanted with the
Reveal ICM.
Subjects will have required follow up visits at baseline, implant, 6 months, 12
months, 18 months (24 and 30 months). Follow-up wil continue until the last
subject has completed the 18 month follow-up.
Intervention
Interverstions are;
- Questionnaire (EQ5D) at basline and the (unplanned) follow-ups
- blood collection at baseline
- 24h ECG monitoring at baseline if the subject has not had one within the
previous 90 days prior to enrollment
- echo at baseline if the subject has not had one within the previous 6 months
prior to enrollment
Study burden and risks
See protocol page 34-35
All the equipment and the implantable devices in the REVEAL AF study are
market-released and are used in accordance with medical, technical, and
ethical standards and in accordance with their approved and intended use. There
are no incremental risks introduced to the subject as a result of participation
in the REVEAL AF study. There are potential risks and discomforts associated
with receiving a subcutaneous
insertable cardiac monitor.
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Listed location countries
Age
Inclusion criteria
* Patient meets the approved indications to receive the Reveal ICM
* Patient is suspected, based on symptomatology and/or demographics, of having atrial fibrillation or at high risk of having AF, as determined by the clinical investigator
* Patient has a CHADS2 score >= 3 OR has a CHADS2 score = 2 with at least one of the following documented:
o Coronary artery disease
o Renal impairment (GFR 30-60 ml/min)
o Sleep apnea
o COPD
Exclusion criteria
* Patient has a documented history of AF or atrial flutter
* Patient had an ischemic stroke or TIA within past year prior to enrollment
* Patient has a history of a hemorrhagic stroke
* Patient is currently implanted with an IPG, ICD, CRT-P, or CRT-D device
* NYHA Class IV Heart Failure patient
* Patient had heart surgery within previous 90 days prior to enrollment
* Patient had an MI within the previous 90 days prior to enrollment
* Patient is taking chronic immuno-suppressant therapy
* Patient is taking an anti-arrhythmic drug
* Patient is contraindicated for long term anticoagulation medication
* Patient is taking a long-term anticoagulation medication
Design
Recruitment
Medical products/devices used
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 | NCT01727297 |
| CCMO | NL44898.060.13 |