Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 12:09 PM
Study NCT ID:
NCT07444320
Status:
RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Novel Waveforms Delivered Using the FARAPULSE™ PFA System
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
A Multicenter Evaluation of Novel Waveforms Delivered Using the FARAPULSE™ PFA System in Patients With Atrial Fibrillation
Status:
RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPULSE-EVO
Brief Summary:
This is a multicenter, prospective, single-arm, feasibility study to evaluate the safety and effectiveness of the waveforms being delivered using the FARAPULSE PFA System in patients with Paroxysmal Atrial Fibrillation (PAF) and Persistent Atrial Fibrillation (PersAF).
Detailed Description:
The objective of this feasibility study is to:
* Evaluate the initial safety and acute performance of investigational waveform(s) delivered using the FARAPULSE™ PFA System in patients with Paroxysmal Atrial Fibrillation (PAF) and Persistent Atrial Fibrillation (PersAF).
* Assess the feasibility of the ablation workflow and waveform delivery.
* Characterize acute and chronic lesion durability, procedure efficiency, and waveform exposure patterns.
* Evaluate the initial safety and acute performance of investigational waveform(s) delivered using the FARAPULSE™ PFA System in patients with Paroxysmal Atrial Fibrillation (PAF) and Persistent Atrial Fibrillation (PersAF).
* Assess the feasibility of the ablation workflow and waveform delivery.
* Characterize acute and chronic lesion durability, procedure efficiency, and waveform exposure patterns.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: