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| ID | Type | Description | Link |
|---|---|---|---|
| S-20080066 |
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The primary aim of the study is to assess the efficacy of continuous rhythm monitoring with an implantable loop recorder (ILR) compared to conventional ambulatory electrocardiography in detecting episodes of atrial fibrillation after pulmonary vein isolation (PVI). The secondary aim is to assess the efficacy of PVI during a two years follow-up and to assess the reliability of the implantable loop recorder in detecting atrial fibrillation.
50 patients will be enrolled into the study. After enrollment an implantable loop recorder will be implanted at least 6 weeks before scheduled PVI. All patients will be followed for 24 months after PVI. During the follow-up period a 72-hours ambulatory electrocardiographic monitoring will be performed at 1, 6, 12, 18, and 24 months. Transthoracic echocardiography will be performed at enrollment, 3, 12, and 24 months after PVI. Moreover, quality of life will be assessed at baseline, and 6 and 12 months after PVI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | There is only one group in this cohort study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantable loop recorder (ILR) | Device | The ILR will be implanted subcutaneous following standard surgical procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with atrial fibrillation detected by implantable loop recorder and number of patients with atrial fibrillation detected by conventional ambulatory electrocardiographic monitoring | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of asymptomatic and symptomatic atrial fibrillation episodes | 12 months | |
| Number of symptomatic and asymptomatic atrial fibrillation episodes | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Axel Brandes, MD | Odense University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Odense | 5000 | Denmark | |||
| Academician E. N. Meshalkin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29478027 | Derived | Bjorkenheim A, Brandes A, Magnuson A, Chemnitz A, Edvardsson N, Poci D. Patient-Reported Outcomes in Relation to Continuously Monitored Rhythm Before and During 2 Years After Atrial Fibrillation Ablation Using a Disease-Specific and a Generic Instrument. J Am Heart Assoc. 2018 Feb 24;7(5):e008362. doi: 10.1161/JAHA.117.008362. | |
| 27418324 |
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| Novosibirsk |
| 630055 |
| Russia |
| Örebro University Hospital | Örebro | 70185 | Sweden |
| Bjorkenheim A, Brandes A, Chemnitz A, Magnuson A, Edvardsson N, Poci D. Rhythm Control and Its Relation to Symptoms during the First Two Years after Radiofrequency Ablation for Atrial Fibrillation. Pacing Clin Electrophysiol. 2016 Sep;39(9):914-25. doi: 10.1111/pace.12916. Epub 2016 Aug 5. |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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