Clinical trial NCT06431815: ADVENT Post Approval Study
Official title: Prospective, Multi-site Safety and Effectiveness Post-Approval Study of FARAPULSE Pulsed Field Ablation in Paroxysmal Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Paroxysmal Atrial Fibrillation
Keywords: Pulsed Field Ablation
PFA
Pulmonary Vein Isolation
PVI
Ablation
Atrial Fibrillation
AF
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2024-05-29
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation (PAF) who are indicated for a de-novo pulmonary vein isolation ablation with the FARAPULSE Pulsed Field Ablation (PFA) System.

Brief summary: The ADVENT Post Approval Study (PAS) is a prospective, global, multicenter, observational study.

Detailed description: The objective of ADVENT PAS is to evaluate the long-term safety and effectiveness profile of the FARAPULSE Pulsed Field Ablation System when used to perform pulmonary vein isolation (PVI) in the de-novo ablation treatment of patients with paroxysmal atrial fibrillation (PAF).

Eligibility criteria: Inclusion Criteria:

* Subjects with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation (PAF) who are indicated for a treatment with the FARAPULSE Pulsed Field Ablation (PFA) System\*; (Subjects refractory, or intolerant or contraindicated to at least one class I or III antiarrhythmic medication or contraindicated to any class I or III medications.)
* Subjects who are willing and capable of providing informed consent;
* Subjects who are willing and capable of participating in all testing and follow-up associated with this clinical study at an approved clinical investigational site;
* Subjects who are of legal age to give informed consent specific to the national law.
* For the LUX-Dx Sub-Study: Subjects with an existing LUX-Dx Insertable Cardiac Monitor (ICM), inserted ≥ 180 days prior to enrollment, or having a LUX-Dx ICM inserted per the investigator's standard of care, up to 7 days after the ablation procedure. Subjects with or having a LUX-Dx ICM inserted per standard of care, up to 7 days after the ablation procedure.

Exclusion Criteria:

* Subjects with any known contraindication to an AF ablation or anticoagulation, including those listed in the Instructions For Use (IFU);
* Subjects with any prior left atrium (LA) ablation;
* Subjects who may need an ablation in the left atrium besides PVI, such as for left-sided atrioventricular reentrant tachycardia (AVRT), left-sided atrial tachycardia (AT) or atypical left-sided atrial flutter (AFL);
* Women of childbearing potential who are or plan to become pregnant during the time of the study (assessment per investigator's discretion);
* Life expectancy of \< 1 year, per investigator's medical judgement.

Primary outcomes:
measure: Composite incidence of patients with procedure-related and device-related serious adverse events at 7-Days and 12-months post-Index Procedure.
timeFrame: 12 Months
measure: Treatment success, defined as the incidence of subjects with successful isolation of clinically relevant pulmonary veins AND patients without recurrence or interventions for AF, AFL, AT after the blanking period through 12 months.
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Mobile Infirmary Medical Center
state: Alabama
city: Scottsdale
country: United States
facility: Scottsdale Healthcare - Shea
state: Arizona
city: Oakland
country: United States
facility: Alta Bates Summit Medical Center
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Florida Heart Rhythm Specialists, PLLC
state: Florida
city: Jacksonville
country: United States
facility: Baptist Medical Center
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
city: Tampa
country: United States
facility: AdventHealth Tampa
state: Florida
city: Savannah
country: United States
facility: Memorial Health University Medical Center
state: Georgia
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Flushing
country: United States
facility: New York Hospital Queens
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Northwell Health
state: New York
city: Greenville
country: United States
facility: East Carolina University Medical Center
state: North Carolina
city: Tulsa
country: United States
facility: Hillcrest Medical Center
state: Oklahoma
city: Harrisburg
country: United States
facility: Pinnacle Health at Harrisburg Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: Prisma Health Richland Hospital
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: University of Texas Houston Health Science Center
state: Texas
city: Houston
country: United States
facility: Orion Medical
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Florianópolis
country: Brazil
facility: Sos Cardio Servicoshospitalares Ltda
state: Santa Catarina
city: São Paulo
country: Brazil
facility: Instituto do Coração do HCFMUSP
state: Sao Paulo
city: Newmarket
country: Canada
facility: Southlake Regional General Hospital
state: Ontario
city: Montréal
country: Canada
facility: Institut de Cardiologie de Montreal-Hospital
state: Quebec
city: Québec
country: Canada
facility: Institut universitaire de Cardiologie et de Pneumologie de Quebec
state: Quebec
city: Concepción
country: Chile
facility: Hospital Regional de Concepcion
state: Biobio
Study officials:
affiliation: Northwell Health, Lenox Hill Hospital
name: Stavros E Mountantonakis, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: