Safety & Effectiveness of the CardioWave Pulsed Field Ablation System With the QuickShot Nav Large-Area Focal Catheter for Ablation of Persistent Atrial Fibrillation

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The study evaluates the safety and effectiveness of the investigational QuickShot Nav configuration of the CardioWave System for focal catheter ablation of persistent atrial fibrillation (PerAF).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Diagnosis of recurrent symptomatic paroxysmal AF (PAF) or persistent AF (PerAF) with the following documentation:

• Paroxysmal AF (Phase A participants)

⁃ Physician's note indicating symptoms consistent with recurrent symptomatic PAF AND

⁃ At least one documented episode of AF captured continuously on 12-lead ECG, or for at least 30 seconds on transtelephonic monitor (TTM), Holter monitor, telemetry strip, or similar within 12 months prior to enrollment

• Persistent AF (Phase A, B, and C participants)

⁃ Physician's note indicating symptoms consistent with recurrent symptomatic PerAF AND

⁃ Any 24-hour ECG recording of continuous AF within 12 months prior to enrollment OR

⁃ Two ECGs from any form of rhythm monitoring showing continuous AF taken at least 7 days apart within 12 months prior to enrollment OR

⁃ History of ≥2 direct current cardioversion (DCCV) performed within 12 months prior to enrollment

• Failure or intolerance of at least one antiarrhythmic drug (AAD) (Class I - IV) for AF, as evidenced by recurrent symptomatic PerAF or intolerable side effects due to the AAD

• Age 18 through 75 years-old on the day of enrollment

• Patient is indicated for an ablation procedure according to society guidelines or study site practice

• Patient is willing and able to give informed consent and is willing, able, and committed to participate in baseline and follow-up evaluations for the full duration of the study

Locations
Other Locations
Croatia
KBC Split
RECRUITING
Split
Contact Information
Primary
Tine Wouters
twouters@cardiofocus.com
+32 498 774371
Backup
Vikramaditya Mediratta
vmediratta@cardiofocus.com
714-717-2376
Time Frame
Start Date: 2023-02-27
Estimated Completion Date: 2027-06
Participants
Target number of participants: 200
Treatments
Experimental: Pulsed Field Ablation Treatment
The treatment arm will undergo catheter ablation for persistent atrial fibrillation with the PFA system with a Large-Area Focal Catheter
Related Therapeutic Areas
Sponsors
Leads: CardioFocus

This content was sourced from clinicaltrials.gov