Safety And FEasibility of a Simplified Deep Sedation Protocol for Pulsed-Field Ablation
NCT07633548 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 40
Last updated 2026-06-08
Summary
The aim of the SAFE-PFA study is to demonstrate the feasibility and safety of a simplified deep-sedation protocol for pulsed-field ablation of atrial fibrillation, with a specific focus on patient-reported outcomes.
Conditions
- Pulsed-field Ablation
- Deep Sedation
- Atrial Fibrillation (AF)
Sponsors & Collaborators
-
University Hospital, Caen
lead OTHER
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-01
- Primary Completion
- 2026-11-11
- Completion
- 2026-12-12
Countries
- France
Study Locations
More Related Trials
-
Pulsed Field Ablation in the Coronary Sinus: Feasibility and Safety of a Novel Approach for Mitral Isthmus Block
NCT07577544 ·Status: NOT_YET_RECRUITING
-
The Effect of Pulse Field Ablation of Atrial Fibrillation Involving Posterior Wall Ablation on Atrial Mechancis Assessed by Cardiac Magnetic Resonance Imaging
NCT07499531 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Pulsed Field Ablation Outcomes With Efficacy and Randomization in Atrial Fibrillation (POWER-AF)
NCT07601763 ·Status: RECRUITING ·Phase: NA
-
Application-Based Integrated Care in Patients After Pulse Field Ablation
NCT07119528 ·Status: RECRUITING ·Phase: NA
-
A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE)
NCT04524364 ·Status: COMPLETED ·Phase: NA
-
Cardiac Surgical Treatment by Radiofrequency Ablation on Valvular Patients: Efficacy at 3 Months
NCT00259623 ·Status: COMPLETED ·Phase: NA
-
Atrial Remodeling After PFA Substrate Modification for Persistent AF (PeAF)
NCT07675395 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Inflammatory Response Following " Pulsed Field Ablation " vs. Radiofrequency Ablation-2
NCT06160076 ·Status: COMPLETED
-
Exploratory Safety and Effectiveness Evaluation of Pulsed Field Ablation (PFA) by Balloon Catheter With TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF)
NCT06495216 ·Status: WITHDRAWN ·Phase: NA
-
Safety and Initial Efficacy Study of a Cardiac Surgical Pulsed Field Ablation System for the Treatment of Atrial Fibrillation
NCT07410962 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
A Single Arm Pilot Study of Pulsed Field Ablation in the Treatment of Paroxysmal Atrial Fibrillation
NCT04474054 ·Status: COMPLETED ·Phase: NA
-
Prospective Study on the Effectiveness and Safety of Bi-polar Pulse-field Tip-catheter Ablation for Atrial Fibrillation in China（POTENTIAL-AF）
NCT07627685 ·Status: NOT_YET_RECRUITING
-
AcQForce Pulsed Field Ablation-CE
NCT05113056 ·Status: COMPLETED ·Phase: NA
-
Pulsed Field Ablation for Cavotricuspid Isthmus Dependent Atrial Flutter Cohort Study
NCT07012460 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Safety and Efficacy of Conscious Sedation Versus General Anesthesia in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation
NCT07541339 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
EUropean Real World Outcomes With Pulsed Field AblatiOn
NCT05823818 ·Status: COMPLETED
-
Left Atrial Function After Pulsed Field Ablation of Atrial Fibrillation
NCT06478342 ·Status: NOT_YET_RECRUITING
-
Pulsed-Field Ablation With/Without Electrogram Mapping
NCT07541989 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Pulsed Field Ablation With Concomitant Radiofrequency Cardioneuroablation in Patients With Paroxysmal Atrial Fibrillation
NCT07171463 ·Status: RECRUITING ·Phase: NA
-
Evaluation of the Safety and Efficacy of the CardioPulseTM PuLsed fiEld Ablation SystEm in Patients With Paroxysmal Atrial Fibrillation (PLEASE-AF Study)
NCT05114954 ·Status: COMPLETED ·Phase: NA
-
Clinical Outcomes of Persistent Atrial Fibrillation Ablation Using Ablation Index-guided Radiofrequency Catheter Ablation in Patients With Continuous Monitoring
NCT05406310 ·Status: WITHDRAWN
-
Association Between Early Recurrence and Long-Term Recurrence After Pulsed Field Ablation for Atrial Fibrillation: Prospective Real-World Evidence From China
NCT07518966 ·Status: RECRUITING
-
Pulsed Field Ablation (PFA) vs Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation
NCT06096337 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Evaluation of the Efficacy of Pulmonary Vein Isolation by Pulsed-field Ablation in Persistent Atrial Fibrillation: a Multicenter Study With Follow-up by Implantable Cardiac Monitor
NCT06985901 ·Status: RECRUITING ·Phase: NA
-
NS-PFA Catheter Ablation of Paroxysmal Atrial Fibrillation With the Pulse Biosciences CellFX System
NCT07018596 ·Status: RECRUITING ·Phase: NA