The FARAPULSE FARA-Freedom Trial A Prospective Open Label Single Arm Post Market Clinical Follow-Up Trial of the FARAPULSE Pulsed Field Ablation System in Patients With Paroxysmal Atrial Fibrillation

Paroxysmal Atrial Fibrillation Clinical Trial

— FARA-Freedom  

Official title:

The FARAPULSE FARA-Freedom Trial A Prospective Open Label Single Arm Post Market Clinical Follow-Up Trial of the FARAPULSE Pulsed Field Ablation System in Patients With Paroxysmal Atrial Fibrillation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05072964
• Other study ID #: CS1169
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 21, 2021
• Est. completion date: July 2024

Study information

• Verified date: January 2024
• Source: Farapulse, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Post-Market Clinical Follow-Up trial is a prospective, multi-center, open-label, single-arm clinical follow-up study designed to provide long-term safety feasibility, effectiveness and performance of the FARAPULSE Pulsed Field Ablation System for the treatment of Paroxysmal Atrial Fibrillation (PAF).

Description:

The primary and secondary Safety, Feasibility, Effectiveness and Performance will be evaluated against pre-specified criteria as determined by the Sponsor and FDA. The criteria set in this study have been previously used to demonstrate Safety, Feasibility, Effectiveness and Performance in FARAPULSE Pulsed Field Ablation System for the treatment of Paroxysmal Atrial Fibrillation (PAF).

The analysis of the primary safety and performance objective will take place once all the subjects with a study FARAPULSE Pulsed field ablation procedure attempt have reached 12 months of follow-up post-pulsed field ablation procedure.

The analyses of the primary effectiveness objective will take place once all the subjects with a study pulsed field ablation procedure attempt have reached 34 ~ 36 months of follow-up post-pulsed field ablation procedure.

The analyses for the secondary objectives will take place once all subjects with a study pulsed field ablation procedure attempt have reached 34~36 months of follow-up post-pulsed field ablation procedure.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosis of paroxysmal atrial fibrillation (PAF), AND

• Two (2) or more episodes of recurrent PAF during the 6 months preceding the consent Date, AND

• At least 1 episode of Atrial Fibrillation (AF) documented with a tracing within 12 months preceding the consent date.

• Age 18 years or older

• Therapeutic Failure for the treatment of Atrial Fibrillation (effectiveness or intolerance) of at least one active AAD for rhythm control.

• Willing and Capable of providing Informed Consent to undergo study procedures AND

• Participate in all examinations and follow-up visits and tests associated with this clinical study

Exclusion Criteria:

• Any previous left atrial (LA) ablation (except permissible retreatment subjects)

• Any previous LA surgery

• Current intracardiac thrombus (can be treated after thrombus is resolved)

• Presence of any pulmonary vein stents

• Presence of any pre-existing pulmonary vein stenosis

• Body Mass Index (BMI) >45.0

• Anteroposterior Left Atrial diameter > 5.5 cm by TTE/ICE

• Presence of any cardiac valve prosthesis

• Clinically significant mitral valve regurgitation or stenosis

• Myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3 month interval preceding the Consent Date

• Unstable angina

• Any cardiac surgery which occurred during the 3 month interval preceding the Consent Date

• Any significant congenital heart defect corrected or not (including atrial septal defects or pulmonary vein abnormalities but not including minor PFO)

• NYHA class III or IV congestive heart failure

• Left ventricular ejection fraction (LVEF) < 35%

• 2º (Type II) or 3º atrioventricular block

• Presence of a permanent pacemaker, biventricular pacemaker, atrial defibrillator or any type of implantable cardiac defibrillator (with or without biventricular pacing function)

• Hypertrophic cardiomyopathy

• Active Systemic infection

• Uncontrolled hyperthyroidism

• Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the Consent Date.

• Any woman known to be pregnant

• Solid organ or hematologic transplant, or currently being evaluated for an organ transplant

• Severe lung disease, pulmonary hypertension, or any lung disease associated with chronic abnormal blood gases or requiring supplemental oxygen

• Renal insufficiency with an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant

• Active malignancy, or history of treated malignancy within 24 months of enrollment (other than cutaneous basal cell or squamous cell carcinoma)

• Life expectancy less than one (1) year

• Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study (data collection for registries or retrospective studies is permitted)

• Unwilling or unable to comply fully with study procedures and followup

• Clinically significant psychological condition that in the Investigator's opinion would prohibit the subject's ability to meet the protocol requirements

• Other uncontrolled medical conditions that may modify device effect or increase risk, including uncontrolled diabetes mellitus, untreated sleep apnea or active alcohol abuse

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• FARAPULSE Pulsed Field Ablation System
A pulmonary vein isolation will be performed using catheter ablation

Locations

Country	Name	City	State
Belgium	AZ Sint-Jan Brugee	Brugge
Belgium	Jessa Ziekenhuis	Hasselt
Czechia	Neuron Medical	Brno
Czechia	IKEM Cardiac Center	Prague
Czechia	Nemocnice Na Homolce	Prague
Denmark	Copenhagen(Gentofte) Hospital	Hellerup
Germany	Rhön Klinikum	Bad Neustadt an der Saale
Germany	Heart- and Diabetescenter NRW	Bad Oeynhausen
Germany	UK Koln herzzentrum	Cologne
Germany	Alfried Krupp Krankenhays	Essen
Germany	CCB Frankfurt	Frankfurt
Germany	Asklepios-Hamburg,Germany	Hamburg
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Netherlands	Catherina	Eindhoven
Netherlands	UMCG	Groningen
Spain	CUN	Pamplona
Switzerland	Inselspital - Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Farapulse, Inc.

Countries where clinical trial is conducted

Belgium,  Czechia,  Denmark,  Germany,  Netherlands,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness: Percentage of Participants Free of Chronic Treatment Failure Through 12 Months and Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter	Evaluated by assessing the rate of subjects free of chronic treatment failure with paroxysmal atrial fibrillation who have failed one Antiarrhythmic Drugs (AAD).; Includes both acute procedural success ( Demonstration of Acute Vein Success in all attempted PVs using the FARAPULSE Pulsed Field Ablation System during the first ablation procedure (Index or or rescheduled index Procedure	12 Months
Primary	Safety: Percentage of Participants Experiencing Composite Safety Endpoint(CSE) Through 12 Months	To demonstrate safety of FARAPULSE Pulsed Field Ablation System, by assessing the rate of subjects experiencing Early and Late onset Composite Safety Endpoints(CSE) with paroxysmal atrial fibrillation who have therapeutic failure of at least one AntiArrhythmic Drug (AAD)	12 Months
Secondary	Additional Safety Analyses: Percentage of Participants free from any of the device or procedure related SAE	Freedom from a serious adverse event (SAE) which has not been categorized as a Pulsed Field Ablation procedure event.	12 Months
Secondary	Additional Performance Analyses: Acute Procedural Success; Acute Vein Success; Acute Chronic Success	Demonstration of Acute Vein Success in all attempted PVs using the FARAPULSE Pulsed Field Ablation System during the first ablation procedure (Index or Rescheduled Index Procedure)	12 Months