Evaluation of the AF detection performance of the BioMonitor III ICM in patients who are scheduled for a PVI in comparison to simultaneous Holter monitoring.
ID
Bron
Verkorte titel
Aandoening
Paroxysmal and persistent atrial fibrillation
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
AF detection performance metrics of the BioMonitor III ICM device compared to that of simultaneous Holter monitoring in patients before and after PVI.
AF detection performance of the BioMonitor III ICM device will be expressed as sensitivity, specificity, positive predictive value and negative predictive value (both for episodes and duration).
Achtergrond van het onderzoek
Rationale: The BioMonitor III is an insertable cardiac monitor (ICM) which is capable to automatically detect atrial fibrillation (AF). As ICMs are increasingly being used to detect AF recurrence after pulmonary vein isolation (PVI), data on the performance of the AF detection algorithm in this specific population is important.
Objective: Evaluation of the AF detection performance of the BioMonitor III ICM in patients who are scheduled for a PVI in comparison to simultaneous Holter monitoring.
Study design: Single-center prospective observational study in which the AF detection performance of the BioMonitor III ICM will be investigated before and after PVI.
Study population: Thirty adult patients with paroxysmal or persistent AF who are scheduled to undergo PVI.
Intervention: A BioMonitor III ICM will be implanted at study entry. At the 1-week post-insertion visit (scheduled in the 3 months prior to PVI), patients will receive a Holter for up to 4 consecutive days (minimum 48 hours). In the period 3 to 5 months post-PVI, patients will receive another Holter monitor for up to 4 consecutive days (minimum 48 hours). After completion of the second Holter monitoring period, the study will end for the patient. The follow-up period after ICM insertion will be at least 6 months.
Main study parameters/endpoints: Primary endpoints are the sensitivity, specificity, positive predictive value and negative predictive value of AF detection by the BioMonitor III in comparison to Holter monitoring at the 2 timepoints (pre- and post PVI). Secondary endpoint is the freedom from ICM- or insertion-related complications at 6 months post-ICM insertion.
Doel van het onderzoek
Evaluation of the AF detection performance of the BioMonitor III ICM in patients who are scheduled for a PVI in comparison to simultaneous Holter monitoring.
Onderzoeksopzet
Start 01-12-2019, FPI 18-12-2019
Inclusion period 9 months scheduled
Follow-up minimal 6 months after ICM implantation in last patient included
Onderzoeksproduct en/of interventie
Implantation of the BioMonitor III ICM device.
Publiek
Sing-Chien Yap
+3150031551
s.c.yap@erasmusmc.nl
Wetenschappelijk
Sing-Chien Yap
+3150031551
s.c.yap@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
1. Diagnosis of paroxysmal or persistent AF
2. Subject scheduled to undergo PVI within 6 months
3. Subject willing and able to comply with the follow-up requirements of the study
4. Written informed consent obtained from subject aged 18 years or older
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
A potential subject who meets any of the following criteria will be excluded from participation in this study:
1. Diagnosis of long-standing persistent AF
2. Subjects implanted with a previous ICM, pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy device
3. Subjects with an active infection
4. Subjects enrolled in another clinical study which may confound the results of this study
5. Subjects with a life expectancy of <1 year due to any condition
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7777 |
| CCMO | NL70462.078.19 |
| OMON | NL-OMON48234 |