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The study is a prospective, single-arm, pre-market clinical study and will enroll up to 300 subjects at up to 26 sites in the United States (US) for analysis of primary objectives. No single site may contribute more than 15% of the enrollments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary Vein Isolation Ablation | Experimental | Pulmonary Vein Isolation Ablation utilizing the Sphere-360 and Affera Mapping and Ablation System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sphere-360 Pulsed Field Ablation Catheter with the Affera Mapping and Ablation System | Device | Pulmonary Vein Isolation using the Sphere-360 Pulsed Field Ablation Catheter with the Affera Mapping and Ablation System |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from Atrial Tachyarrhythmia Recurrence Through 12 Months Post-Ablation | Freedom from documented recurrence of atrial fibrillation, atrial tachycardia, or atrial flutter based on electrocardiographic data through 12 months (365 days) and excluding a 90-day blanking period. The study requires 24-hour Holter monitoring at 6 and 12 months in addition to weekly and symptomatic trans-telephonic monitoring (TTM) transmissions through 12 months, and 12-lead ECGs at all follow up visits. Atrial tachyarrhythmia observed via any of those instruments, as well as acute procedural failure, repeat ablation, cardioversion, an increase in anti-arrhythmic drugs, or use of amiodarone at any time during the study will constitute a failure. | Index ablation procedure through 12 months of follow up. |
| Incidence of Device- and Procedure-Related Serious Adverse Events Through 6 Months | Primary safety events (device- and procedure-related serious adverse events, as adjudicated by the Clinical Events Committee) for the Sphere-360 Catheter and Affera Mapping and Ablation System: Within 7 days: heart block, major bleeding needing transfusion, MI, permanent phrenic nerve paralysis, pulmonary edema, severe pericarditis, significant effusion/tamponade, stroke/CVA, systemic/pulmonary embolism needing intervention, TIA, vagal nerve injury causing esophageal dysmotility/gastroparesis, vascular access complications needing intervention, AKI needing dialysis or hospitalization >48h or prolonged >48h, death, any device/procedure-related CV/pulmonary event causing/prolonging hospitalization >48h (excludes recurrent AF/AT/AFL). Within 3 months: atrioesophageal/esophago-pericardial fistula, esophageal perforation (device/procedure related; excludes TEE/nasogastric tube injury). Within 6 months: pulmonary vein stenosis (≥70% diameter reduction). | Index ablation procedure through 6 months of follow up. |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Endpoint: Quality of Life (AFEQT) | Change in AFEQT score from baseline to 12 months. The AFEQT is an AF-specific health-related quality of life questionnaire, scored 0-100 (higher scores indicate better quality of life). | Index ablation procedure through 12 months of follow up. |
| Secondary Endpoint: Quality of Life (EQ-5D) |
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Inclusion Criteria:
A diagnosis of recurrent symptomatic PAF, which is defined as continuous AF episode lasting longer than 30 seconds but terminates spontaneously or with intervention within 7 days of onset, documented by the following:
Adults who are ≥18 and ≤80 years of age on the day of enrollment.
Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leah Crocker | Contact | 763-526-6237 | leah.c.crocker@medtronic.com |
| Name | Affiliation | Role |
|---|---|---|
| Vivek Reddy, MD | Icahn School of Medicine at Mt Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arrhythmia Research Group | Recruiting | Jonesboro | Arkansas | 72401 | United States |
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Change in EQ-5D composite score from baseline to 12 months. The EQ-5D is a standardized instrument for generic health status, with composite scores indexed to a US reference population. |
| Index ablation procedure through 12 months follow up. |
| Scripps Memorial Hospital | Recruiting | La Jolla | California | 92037 | United States |
|
| NCH Rooney Heart Institute | Recruiting | Naples | Florida | 34102 | United States |
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| Memorial Health University Medical Center | Recruiting | Savannah | Georgia | 31404 | United States |
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| Northwestern University | Recruiting | Chicago | Illinois | 60611 | United States |
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| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| Southcoast Health System | Recruiting | Fall River | Massachusetts | 02720 | United States |
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| Minneapolis Heart Institute Foundation | Recruiting | Minneapolis | Minnesota | 55407 | United States |
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| Mayo Clinic | Recruiting | Rochester | Minnesota | 55902 | United States |
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| The Valley Hospital | Recruiting | Paramus | New Jersey | 07652 | United States |
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| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
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| Northwell Health Lenox Hill Hospital | Recruiting | New York | New York | 10075 | United States |
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| Duke University Medical Center | Recruiting | Durham | North Carolina | 27710 | United States |
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| Atrium Health Wake Forest Baptist Medical Center | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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| Bethesda North Hospital | Recruiting | Cincinnati | Ohio | 45220 | United States |
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| Cleveland Clinic Foundation | Recruiting | Cleveland | Ohio | 44195 | United States |
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| The Ohio State University Wexner Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
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| Ohio Health Research and Innovation Institute | Recruiting | Columbus | Ohio | 43214-3907 | United States |
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| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
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| Texas Cardiac Arrhythmia Research Foundation | Recruiting | Austin | Texas | 78705 | United States |
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| Inova Fairfax Hospital | Recruiting | Falls Church | Virginia | 22042 | United States |
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| Sentara Norfolk General Hospital | Recruiting | Norfolk | Virginia | 23507 | United States |
|
| 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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