A Single Arm Pilot Study of Pulsed Field Ablation in the Treatment of Paroxysmal Atrial Fibrillation

NCT04474054 | Completed Results DMC FDA Device

• 1 other identifier: CS0766
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this pilot study is to confirm that endocardial ablation using the FARAPULSE Ablation System Plus with commercial design devices is both safe and effective for treating drug-resistant paroxysmal atrial fibrillation (PAF).

Conditions

Paroxysmal Atrial Fibrillation

Keywords

Catheter Ablation; Paroxysmal Atrial Fibrillaltion; Pulmonary Vein Isolation; Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Occurence of Device-or Procedure-related Early and Late-onset of Serious Adverse Events

  Includes serious adverse events which are device- or procedure-related, and as define din Composite Safety Endpoint definition table occurring within 7 days of the index procedure or hospital discharge, whichever is later, and diagnosed at any time during the follow-up period.

  7 days to12 Months

• Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter

  Includes both acute procedural success (successful electrical isolation of set of lesions around the ostia of all pulmonary veins) and therapeutic success (Re-treatment for AF with ablation using study devices, or if necessary, a commercially approved ablation device after a 3 month blanking period constitute a treatment failure.

  12 months

Study Arms (1)

FARAPULSE Ablation System Plus

EXPERIMENTAL

Ablation using the FARAPULSE Ablation System Plus

Device: Catheter ablation to treat paroxysmal atrial fibrillation

Interventions

Catheter ablation to treat paroxysmal atrial fibrillation DEVICE

A pulmonary vein isolation will be performed using catheter ablation

FARAPULSE Ablation System Plus

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with documented drug resistant symptomatic PAF
• Patients who are ≥ 18 and ≤ 75 years of age on the day of enrollment.
• Patient participation requirements:
• Lives locally.
• Is willing and capable of providing Informed Consent to undergo study procedures.
• Is willing to participate in all examinations and follow-up visits and tests associated with this clinical study.

You may not qualify if:

• AF that is:
• Persistent
• Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible / non-cardiac causes
• Longstanding
• Left atrial anteroposterior diameter ≥ 5.0 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT)
• Any of the following cardiac procedures, implants or conditions:
• Clinically significant arrhythmias other than AF, AFL or AT
• Previous endocardial or epicardial ablation or surgery for AF
• Hemodynamically significant valvular disease
• Prosthetic heart valve
• Heart Failure for example NYHA Class III or IV CHF, LVEF \<40%, Heart failure hospitalization
• Atrial or ventricular septal defect closure
• Atrial myxoma
• Left atrial thrombus
• Left atrial appendage device or occlusion

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

KBC Split

Split, Croatia

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Christopher (Kit) Schneider
• Organization: FARAPULSE

christopher.schneider@bsci.com

617-686-7661

Study Officials

• Ante Anic

  University Hospital of Split

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 16, 2020
• Study Start: July 7, 2020
• Primary Completion: December 21, 2021
• Study Completion: December 21, 2021
• Last Updated: April 21, 2023
• Results First Posted: April 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)