Trials / Withdrawn
WithdrawnNCT06495216
Exploratory Safety and Effectiveness Evaluation of Pulsed Field Ablation (PFA) by Balloon Catheter With TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF)
Exploratory Safety and Effectiveness Evaluation of Pulsed Field Ablation by a Balloon Catheter With the TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF)
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Biosense Webster, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to explore preliminary safety and acute effectiveness of pulsed field ablation by the ablation system (pulsed field ablation balloon 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 causes abnormal blood flow.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Pulsed Field Ablation by a Balloon Catheter with the TRUPULSE Generator | Pulsed field ablation balloon catheter and TRUPULSE generator will be used for PV ablation. |
Timeline
- Start date
- 2024-08-17
- Primary completion
- 2025-03-26
- Completion
- 2025-12-26
- First posted
- 2024-07-10
- Last updated
- 2025-02-04
Source: ClinicalTrials.gov record NCT06495216. Inclusion in this directory is not an endorsement.