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NCT03691571 · ClinicalTrials.gov registry record · NA
Esophageal Cooling for AF Ablation
A NA study of Atrial Fibrillation, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 55
- Enrollment target
- 1
- Study location
NCT03691571: Completed NA study of Atrial Fibrillation, sponsored by University of Pennsylvania.
NCT03691571 is a NA study of Atrial Fibrillation that has completed, run by University of Pennsylvania. The registered enrollment target is 55 participants, below the 2,997-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03691571, a NA study of Atrial Fibrillation, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- NA
- Development phase
- 55 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine if esophageal cooling using the Attune Medical Esophageal Heat Transfer Device (EnsoETM) limits the number or seriousness of injury to the esophagus during atrial fibrillation ablation procedures. The EnsoETM is an FDA cleared device used for temperature management, but is not routinely used during atrial fibrillation ablation procedures.
Primary Outcome
Any injury, occurrence rate measured by EGD
Conditions Studied
Interventions
- DEVICE Control
- DEVICE Esophageal Cooling
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Perelman Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2018-10-11 |
| Est. Completion | 2021-02-28 |
| Phase | NA |
What the finished NCT03691571 record still lists
NCT03691571 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 2,997-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions - of which Control is the first listed.
NCT03691571 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03691571 about?
NCT03691571 is a clinical study titled "Esophageal Cooling for AF Ablation". The purpose of this study is to determine if esophageal cooling using the Attune Medical Esophageal Heat Transfer Device (EnsoETM) limits the number or seriousness of injury to the esophagus during atrial fibrillation ablation procedures. The EnsoETM is an FDA cleared device used for temperature man...
What is the current status of trial NCT03691571?
This trial is currently completed. It is a NA study. The enrollment target is 55 participants. The study started on 2018-10-11. Estimated completion is 2021-02-28.
What conditions does trial NCT03691571 study?
This clinical trial studies the following conditions: Atrial Fibrillation.
What interventions are being tested in trial NCT03691571?
The interventions under investigation include: Control (DEVICE), Esophageal Cooling (DEVICE).
Who is sponsoring clinical trial NCT03691571?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03691571 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03691571's enrollment target sits among peer trials
55 171st of 202 higher than 32 of 202 other Atrial Fibrillation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atrial Fibrillation 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.
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