Treatment of Persistent Atrial Fibrillation With Sphere-9 Catheter and Affera Mapping and Ablation System
Public ClinicalTrials.gov record NCT05120193. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Treatment of Persistent Atrial Fibrillation With the Sphere-9 Mapping and Ablation Catheter and the Affera Mapping and Ablation System
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a prospective, multicenter, randomized clinical evaluation of the Sphere-9 Mapping and Ablation Catheter with the Affera Mapping and Ablation System. Subjects will be randomly assigned 1:1 to receive treatment with either the Sphere-9 Mapping and Ablation Catheter and the Affera Mapping and Ablation System (investigational device) or the THERMOCOOL SMARTTOUCH® SF radiofrequency ablation catheter (control device).
Study identification
- NCT ID
- NCT05120193
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 477 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 14, 2021 (Actual)
- Primary completion
- Jan 10, 2024 (Actual)
- Completion
- Jan 10, 2024 (Actual)
- Last update posted
- Apr 23, 2025
2021 – 2024
United States locations
- U.S. sites
- 19
- U.S. states
- 13
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arrhythmia Institute at Grandview | Birmingham | Alabama | 35243 | — |
| Banner University Medical Center Phoenix | Phoenix | Arizona | 85006 | — |
| Arrhythmia Research Group | Jonesboro | Arkansas | 72401 | — |
| Pacific Heart Institute | Santa Monica | California | 90404 | — |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| Naples Heart Institute | Naples | Florida | 34102 | — |
| AdventHealth Orlando | Orlando | Florida | 32803 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Maimonides Medical Center | Brooklyn | New York | 11219 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Northwell Health | New York | New York | 10075 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | — |
| The OhioHealth Research Institute | Columbus | Ohio | 43214 | — |
| Doylestown Hospital | Doylestown | Pennsylvania | 18901 | — |
| University of Pittsburgh Medical Center Pinnacle Health | Wormleysburg | Pennsylvania | 17043 | — |
| Vanderbilt Medical Center | Nashville | Tennessee | 37232 | — |
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78705 | — |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05120193, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 23, 2025 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05120193 live on ClinicalTrials.gov.