Atrial Fibrillation Clinical Trials

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Feasibility Study of the FARAFLEX Mapping and Pulsed Field Ablation (PFA) System in the Treatment of Persistent Atrial Fibrillation

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The objective of this feasibility study is to evaluate the safety and effectiveness of the FARAFLEX mapping and pulsed field ablation (PFA) catheter, a novel catheter in treating persistent atrial fibrillation (PersAF) or symptomatic Paroxysmal Atrial Fibrillation (PAF).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years of age, or older if required by local law

• Symptomatic, documented, Persistent AF or Paroxysmal AF

• Willing and capable of providing informed consent

• Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center

• Meets all inclusion criteria according to the ELEVATE-PF Protocol

• Planned for adjunctive CTI ablation

• Willing and capable of participating in all assessments and testing associated with this sub-study protocol.

Locations
Other Locations
Belgium
UZ Brussel Hospital
RECRUITING
Brussels
Croatia
Klinicki bolnicki centar Split
RECRUITING
Split
Italy
Fondazione PTV - Policlinico Tor Vergata
RECRUITING
Roma
Contact Information
Primary
Sharda Mehta
sharda.mehta@bsci.com
800-227-3422
Backup
Maria Grazia Pietropaolo
MariaGrazia.Pietropaolo@bsci.com
+393463514999
Time Frame
Start Date: 2025-02-17
Estimated Completion Date: 2027-09-15
Participants
Target number of participants: 250
Treatments
Other: FARAFLEX Treatment group
200 subjects scheduled to undergo endocardial mapping and ablation in the treatment of persistent atrial fibrillation or paroxysmal atrial fibrillation with FARAFLEX mapping PFA catheter and other BSC devices.
Other: ELEVATE-COR sub-study group
Approximately 50 subjects meeting study eligibility requirements will be enrolled in the sub-study at a subset of centers and randomized to undergo endocardial mapping and ablation in the treatment of persistent atrial fibrillation or paroxysmal atrial fibrillation with either the FARAFLEX™ Mapping and PFA System or a commercially approved ablation system. Subjects will also undergo IVUS imaging of their RCA at the following time points: pre- and post-ablation, 3-Months, 12-Months.
Related Therapeutic Areas
Atrial Fibrillation
Sponsors
Leads: Boston Scientific Corporation

This content was sourced from clinicaltrials.gov

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