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The objective of this study is to evaluate whether local impedance (DIRECTSENSEâ„¢) drop on the INTELLANAV STABLEPOINTâ„¢ ablation catheter is associated with late pulmonary vein (PV) reconnections and durable conduction block in patients undergoing de novo PV isolation (PVI) for treatment of paroxysmal atrial fibrillation (PAF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PVI procedure | Other | Subjects will undergo ablation treatment of the pulmonary veins with the Rhythmia HDx mapping system with DirectSense technology. Subjects indicated for ablation treatment of de-novo PAF will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the Informed Consent Form. For all enrolled subjects who undergo the ablation procedure, the subjects will be treated with the commercial Rhythmia HDx System with commercially available Software Version 4.0.1 or greater (commercially approved version) with DIRECTSENSEâ„¢ and Force Computation Software Module; the IntellaMap Orion mapping catheter and the IntellaNav StablePoint ablation catheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablation procedure | Device | Catheter ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav StablePoint ablation catheter |
| Measure | Description | Time Frame |
|---|---|---|
| Association between Local Impedance drop values and PV reconnections | Correlation between local impedance drop collected during the blinded index procedure and sites of late PV reconnection/durable block at 3-months. | 0-3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Association between Local Impedance drop values and acute PV reconnections | Correlation between local impedance drop collected during the blinded index procedure and sites of acute gaps/block after a 20-minute wait period. | 0-1 month |
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Inclusion Criteria:
Exclusion Criteria:
Any known contraindication to an AF ablation or anticoagulation
Continuous AF lasting longer than seven days from onset (no episodes within 365 days from enrollment)
History of previous LA ablation or surgical treatment for AF/AT/AFL
AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
Subjects with life expectancy ≤ 6 months
Structural heart disease, heart conditions, or implanted devices as described below:
History of blood clotting or bleeding disease
Any prior history of documented cerebral infarct, TIA, or systemic embolism [excluding a post-operative deep vein thrombosis (DVT)] ≤180 days prior to enrollment
Active systemic infection
Pregnant, lactating (current or anticipated during study follow up), or women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion)
Subjects who are currently enrolled in any other concurrent study, with the exception of local mandatory governmental registries and observational studies/registries, without written approval from the sponsor
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| Name | Affiliation | Role |
|---|---|---|
| Ignacio Garcia Bolao, MD | Clinica Universitaria de Navarra | Principal Investigator |
| Hüseyin Ince, MD | Vivantes Klinikum am Urban | Principal Investigator |
| Francesco Solimene, MD | Casa Di Cura 'Montevergine' S.P.A. | Principal Investigator |
| Armin Luik, MD | Staedtisches Klinikum Karlsruhe | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vivantes Klinikum Am Urban | Berlin | 10967 | Germany | |||
| Städtisches Klinikum Karlsruhe |
No requests for study data have been made at this time, however Boston's Scientific's policy on data sharing can be found at http:// www.bostonscientific.com/en-US/data-sharing-requests.html
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 20, 2023 | |
| Reset | Mar 6, 2024 |
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| Karlsruhe |
| 76133 |
| Germany |
| Casa di Cura Montevergine S.p.A. | Mercogliano | Avellino | 83013 | Italy |
| Centro Cardiologico Monzino | Milan | 20138 | Italy |
| Clinica Universidad de Navarra | Pamplona | 31008 | Spain |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 20, 2023 | Mar 6, 2024 |
| 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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