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The objective of the study is to demonstrate the safety and feasibility of the Adagio System in subjects with Atrial Flutter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Atrial flutter Ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PolarStart System | Device | Atrial flutter Ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety measured by the percentage of subjects experiencing cardiovascular specific adverse events (CSAE) within thirty 30 days of the ablation procedure. | 30 DAYS |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Success measured by Percentage of subjects with termination of AFl and complete bidirectional conduction block across the subeustachian (cavo-tricuspid) isthmus at the end of the ablation procedure. | 30 minutes | |
| Outcome success | Percent of subjects with absence of AFl at 30 days (30 day ECG and as reported by subject or holter monitor) |
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Inclusion Criteria:
Exclusion Criteria:
Subject had any previous left atrial ablation.
Subject has symptomatic carotid stenosis.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OLV Hospital | Aalst | 9300 | Belgium | |||
| St. Antonius Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34196991 | Derived | Klaver MN, De Potter TJR, Iliodromitis K, Babkin A, Cabrita D, Fabbricatore D, Boersma LVA. Ultralow temperature cryoablation using near-critical nitrogen for cavotricuspid isthmus-ablation, first-in-human results. J Cardiovasc Electrophysiol. 2021 Aug;32(8):2025-2032. doi: 10.1111/jce.15142. Epub 2021 Jul 9. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 6, 2026 |
| ID | Term |
|---|---|
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| 30 days |
| Nieuwegein |
| Netherlands |
| D013568 |
| Pathological Conditions, Signs and Symptoms |