BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF
NCT07181590 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2026-04-08
Summary
This study is designed to obtain real-world clinical evidence on the safety and effectiveness of the Volt PFA System in various use cases, with a sub study designed to address additional clinical evidence needs in electrophysiology.
Conditions
- Paroxysmal AF
- Atrial Arrhythmia
- Atrial Fibrillation
- Persistent Atrial Fibrillation
Interventions
- DEVICE
-
Pulsed Field Ablation
Pulsed Field Ablation using the Volt PFA System
Sponsors & Collaborators
-
Abbott Medical Devices
lead INDUSTRY
Principal Investigators
-
Sarah C Kammer · Abbott Medical Devices
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-11
- Primary Completion
- 2027-08-31
- Completion
- 2027-08-31
- FDA Device
- Yes
Countries
- Austria
- Belgium
- Denmark
- France
- Germany
- Ireland
- Italy
- Netherlands
- Poland
- Portugal
- Spain
- Sweden
Study Locations
More Related Trials
-
Local Potential Measurement In PFA: A Pilot Study
NCT06877156 ·Status: COMPLETED
-
Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation
NCT01687166 ·Status: COMPLETED ·Phase: NA
-
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NCT06495216 ·Status: WITHDRAWN ·Phase: NA
-
Assessment of Pulmonary Vein Isolation Using a Balloon Catheter With Pulsed Field Energy in Atrial Fibrillation
NCT07156877 ·Status: RECRUITING ·Phase: NA
-
FIRM Ablation Versus Pulmonary Vein Isolation for the Treatment of Paroxysmal Atrial Fibrillation (PAF)
NCT02703454 ·Status: TERMINATED ·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
-
A Single Arm Pilot Study of Pulsed Field Ablation in the Treatment of Paroxysmal Atrial Fibrillation
NCT04474054 ·Status: COMPLETED ·Phase: NA
-
VOLT CE Mark Study
NCT06106594 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
A Study of the TactiFlex SE Catheter and Volt PFA Generator in Subjects With PAF:
NCT06676072 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
The Effect of Pulse Field Ablation on Atrial Mechanics in Catheter Ablation of Paroxysmal Atrial Fibrillation
NCT06557876 ·Status: RECRUITING ·Phase: NA
-
Evaluation of the Impact of Pulsed Field Ablation on Autonomic Nervous System Modulation in Paroxysmal Atrial Fibrillation
NCT06647485 ·Status: RECRUITING ·Phase: NA
-
Burst Stimulation for Paroxysmal Atrial Fibrillation
NCT07281898 ·Status: RECRUITING ·Phase: NA
-
The FARAPULSE ADVENT PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial Fibrillation
NCT04612244 ·Status: COMPLETED ·Phase: NA
-
Pulsed ElectRic FiEld Versus Cryoballoon for PAF
NCT07100834 ·Status: COMPLETED ·Phase: NA
-
Pulsed Field Ablation for Non-valvular Atrial Fibrillation After Left Atrial Appendage Occlusion
NCT07313228 ·Status: NOT_YET_RECRUITING
-
A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)
NCT06455098 ·Status: RECRUITING ·Phase: NA
-
Real-world Experience of Catheter Ablation for the Treatment of Paroxysmal and Persistent Atrial Fibrillation
NCT04088071 ·Status: RECRUITING
-
Pulsed Field Ablation for Cavotricuspid Isthmus Dependent Atrial Flutter Cohort Study
NCT07012460 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
AcQBlate Force Sensing Ablation System US IDE Study for Atrial Fibrillation
NCT04904354 ·Status: WITHDRAWN ·Phase: NA
-
Safety and Effectiveness of Pulmonary Vein isOLation And posterioR Wall Ablation wIth pulSed Field Energy in Patients With Paroxysmal and Persistent AF
NCT06099730 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
PeAF-BOX: Feasibility, Safety and Efficacy of PVI + Box Ablation in Persistent Atrial Fibrillation
NCT05045131 ·Status: COMPLETED ·Phase: NA
-
AF Substrate Mapping and Guided Ablation
NCT02571218 ·Status: COMPLETED ·Phase: NA
-
Left Atrial Arrhythmia Substrate Identification After Confirmed durABLE Pulmonary Vein Isolation
NCT04111731 ·Status: COMPLETED ·Phase: NA
-
Multitarget Pulse Field Ablation Guided by Endocardial and Non-invasive Atrial Driver Mapping (PFA+ADM) Pilot Study. Development of an Ablation Strategy to Improve the Efficacy of Long Standing Atrial Fibrillation Ablation in Patients With High Comorbidity Burden or Heart Failure
NCT07118488 ·Status: RECRUITING ·Phase: NA
-
Pulsed Field Ablation and Pulsed Field CRyoAbLation in PErsistent AtriaL FibrilLation
NCT05408754 ·Status: COMPLETED ·Phase: NA