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NCT03729830 · ClinicalTrials.gov registry record
Prospective Evaluation of Open Irrigated Ablation Catheters With High Resolution Mapping to Treat Paroxysmal Atrial Fibrillation
A clinical trial, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- 415
- Enrollment target
NCT03729830: Completed study, sponsored by Boston Scientific Corporation.
NCT03729830 is a clinical trial that has completed, run by Boston Scientific Corporation. The registered enrollment target is 415 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03729830 has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- 415 participants
- Enrollment target
Study Summary
To obtain data for the Rhythmia™ Mapping System in conjunction with Boston Scientific Open-Irrigated (OI) Catheters for ablation of Paroxysmal Atrial Fibrillation (PAF) according to current international and local guidelines. Primary objective: To assess acute and long-term outcomes for the Rhythmia Mapping System in conjunction with Boston Scientific Open-Irrigated Ablation Catheters to treat de novo Paroxysmal Atrial Fibrillation. De Novo PAF is defined as subjects undergoing first ablation procedure for PAF with no prior left atrial ablation (RF, Cryo, Surgical).
Primary Outcome
This measure reports the observed safety event -free rate at 12 Months follow up. The safety events are a composite of acute primary safety events (events occurring within seven days post-procedure or hospital discharge, whichever is later), and chronic primary safety events (events occurring through 3- or 12-months post-procedure, as listed below). Acute primary safety endpoint events are defined as the following: * Death * Myocardial infarction (MI) * Vagal Nerve Injury/Gastroparesis * Trans
Interventions
- DEVICE Boston Scientific Open Irrigated Ablation Catheters
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 415 participants |
| Start Date | 2019-03-04 |
| Est. Completion | 2024-05-03 |
What the finished NCT03729830 record still lists
NCT03729830 is an observational study that tracks outcomes without assigning an intervention. The registered 415 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Boston Scientific Open Irrigated Ablation Catheters is the first listed.
NCT03729830 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03729830 about?
NCT03729830 is a clinical study titled "Prospective Evaluation of Open Irrigated Ablation Catheters With High Resolution Mapping to Treat Paroxysmal Atrial Fibrillation". To obtain data for the Rhythmia™ Mapping System in conjunction with Boston Scientific Open-Irrigated (OI) Catheters for ablation of Paroxysmal Atrial Fibrillation (PAF) according to current international and local guidelines. Primary objective: To assess acute and long-term outcomes for the Rhythmi...
What is the current status of trial NCT03729830?
This trial is currently completed. The enrollment target is 415 participants. The study started on 2019-03-04. Estimated completion is 2024-05-03.
What interventions are being tested in trial NCT03729830?
The interventions under investigation include: Boston Scientific Open Irrigated Ablation Catheters (DEVICE).
Who is sponsoring clinical trial NCT03729830?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
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