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NCT05120193 · ClinicalTrials.gov registry record · NA
Treatment of Persistent Atrial Fibrillation With Sphere-9 Catheter and Affera Mapping and Ablation System
A NA study, sponsored by Medtronic Cardiac Ablation Solutions.
- Completed
- Registry status
- NA
- Development phase
- 477
- Enrollment target
NCT05120193: Completed NA study, sponsored by Medtronic Cardiac Ablation Solutions.
NCT05120193 is a NA study that has completed, run by Medtronic Cardiac Ablation Solutions. The registered enrollment target is 477 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05120193, a NA study, has completed, sponsored by Medtronic Cardiac Ablation Solutions.
- COMPLETED
- Registry status
- NA
- Development phase
- 477 participants
- Enrollment target
Study Summary
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).
Primary Outcome
The primary safety endpoint is the incidence of the following device- or procedure-related serious adverse events (SAEs) following the index ablation procedure: Within 7 days: * Death * Myocardial infarction * Phrenic nerve paralysis * Transient ischemic attack (TIA) * Stroke/cerebrovascular accident (CVA) * Thromboembolism * Major vascular access complications / bleeding * Heart block * Gastroparesis * Severe pericarditis * Hospitalization due to cardiovascular or pulmonary AE Within 30 days
Interventions
- DEVICE Mapping and Ablation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 477 participants |
| Start Date | 2021-12-14 |
| Est. Completion | 2024-01-10 |
| Phase | NA |
What the finished NCT05120193 record still lists
NCT05120193 is an interventional study that assigns participants to a tested intervention. The registered 477 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 1 intervention - of which Mapping and Ablation is the first listed.
NCT05120193 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05120193 about?
NCT05120193 is a clinical study titled "Treatment of Persistent Atrial Fibrillation With Sphere-9 Catheter and Affera Mapping and Ablation System". 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 ...
What is the current status of trial NCT05120193?
This trial is currently completed. It is a NA study. The enrollment target is 477 participants. The study started on 2021-12-14. Estimated completion is 2024-01-10.
What interventions are being tested in trial NCT05120193?
The interventions under investigation include: Mapping and Ablation (DEVICE).
Who is sponsoring clinical trial NCT05120193?
This trial is sponsored by Medtronic Cardiac Ablation Solutions, which has 20 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05120193's enrollment target sits among peer trials
477 219th of 2000 higher than 1,781 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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