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Evaluation of Novel Waveforms Delivered Using the FARAPULSE™ PFA System

Study acronym: IMPULSE-EVO
StatusRecruiting
PhaseNot applicable
Started2026-02-12
View on ClinicalTrials.gov ↗

Amendment history

2026-08-26
minor
3 amendments v4-v6
3 re-verifications since 2026-06-26, no change to tracked fields
2026-05-26
minor
Study Status, Contacts/Locations v3
Study sites3→4
2026-04-29
minor
Study Status, Contacts/Locations v2
Study sites2→3
2026-03-26
minor
Study Status, Eligibility, Contacts/Locations v1
Study sites1→2
Eligibility criteria+21 characters
[...] lation and the arrhythmia symptoms Within 180 days prior to enrollmentEnrollment: A 24-hour continuous ECG recording confirming continuous A [...] rom any regulatory-cleared rhythm monitoring device showing atrial Fibrillation (AF) Willing and capable of providing informed consent Willing a [...] evice, except a WATCHMAN™ device implanted > 90 days before enrollmentEnrollment Valvular Disease - PresensePresence of any of the following: Any prosthetic heart valve, ring o [...] pectancy of less than one (1) year per investigator medical judgementjudgment Concurrent Enrollment - Subjects who are currently enrolled [...]
2026-02-26
minor
Original filing
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).
Trial Details
NCT Number NCT07444320
Lead Sponsor Boston Scientific Corporation
Conditions Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Enrollment 200 participants
Start Date 2026-02-12
Primary Completion 2028-02 (estimated)
Study Completion 2028-02 (estimated)
Updated on ClinicalTrials.gov 2026-09-24