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NCT06144632 · ClinicalTrials.gov registry record · NA
A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic PAF
A NA study, sponsored by Biosense Webster.
- Completed
- Registry status
- NA
- Development phase
- 237
- Enrollment target
NCT06144632: Completed NA study, sponsored by Biosense Webster.
NCT06144632 is a NA study that has completed, run by Biosense Webster. The registered enrollment target is 237 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06144632, a NA study, has completed, sponsored by Biosense Webster.
- COMPLETED
- Registry status
- NA
- Development phase
- 237 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate safety and effectiveness of the Biosense Webster (BWI) ablation system (THERMOCOOL SMARTTOUCH surround flow \[STSF\] catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF), an irregular heart rate that causing abnormal blood flow.
Primary Outcome
PAEs occurring within 7 days of an ablation which uses the BWI ablation system (including atrio-esophageal fistula and pulmonary vein stenosis occurring greater than 7 days of post ablation procedure) will be reported.
Interventions
- DEVICE THERMOCOOL STSF Bi- Directional Navigation Catheter
- DEVICE TRUPULSE Generator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 237 participants |
| Start Date | 2023-12-07 |
| Est. Completion | 2025-10-30 |
| Phase | NA |
What the finished NCT06144632 record still lists
NCT06144632 is an interventional study that assigns participants to a tested intervention. The registered 237 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 (83% lower).
The record links to 0 conditions, and to 2 interventions - of which THERMOCOOL STSF Bi- Directional Navigation Catheter is the first listed.
NCT06144632 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06144632 about?
NCT06144632 is a clinical study titled "A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic PAF". The purpose of this study is to demonstrate safety and effectiveness of the Biosense Webster (BWI) ablation system (THERMOCOOL SMARTTOUCH surround flow \[STSF\] catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal a...
What is the current status of trial NCT06144632?
This trial is currently completed. It is a NA study. The enrollment target is 237 participants. The study started on 2023-12-07. Estimated completion is 2025-10-30.
What interventions are being tested in trial NCT06144632?
The interventions under investigation include: THERMOCOOL STSF Bi- Directional Navigation Catheter (DEVICE), TRUPULSE Generator (DEVICE).
Who is sponsoring clinical trial NCT06144632?
This trial is sponsored by Biosense Webster, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06144632's enrollment target sits among peer trials
237 461st of 2000 higher than 1,540 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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