Clinical trial NCT06526546: ADVENT Trial Long Term Outcomes Evaluating Atrial Fibrillation Progression Study
Official title: ADVENT Trial Long Term Outcomes Evaluating Atrial Fibrillation Progression (ADVENT LTO Study)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Paroxysmal Atrial Fibrillation
Keywords: Persistent Atrial Fibrillation
Pulsed Field Ablation
Cardiovascular Heart Diseases
Antiarrhythmic Anticoagulation
Cardiac monitor
Atrial Fibrillation
Atrial Flutter
Atrial Tachycardia
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2024-07-30
Enrollment: 583
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: Study eligibility criteria are defined below. Subjects who became deceased after completion of the ADVENT Trial will remain eligible for chart review data upon consent of a legally authorized representative (LAR). Subjects unable to complete the 7-day Holter monitor may consent to participate in the chart review portion only.

Brief summary: The (ADVENT LTO) is an observational, non-significant risk study to assess the progression of atrial fibrillation in subjects who received ablation treatment with either the FARAPULSE Pulsed Field Ablation System or thermal ablation in the ADVENT Trial.

Detailed description: This study is an observational, non-significant risk study. Subjects who participated in the FARAPULSE ADVENT Trial (NCT04612244) will be approached for participation.

Eligibility criteria: Inclusion Criteria:

* Subjects who meet all of the following criteria may be given consideration for inclusion in this clinical investigation.
* Subjects who were enrolled, randomized and treated for paroxysmal atrial fibrillation, classified as Modified Intention-to-Treat subjects, and completed the 12-Month Follow-Up in the FARAPULSE ADVENT Trial (CIP CS0934; NCT04612244).
* Subjects or legally authorized representatives who are willing and capable of providing informed consent.
* Subjects who are willing to comply with the protocol requirements.

Exclusion Criteria:

* There are no exclusion criteria for this study.

Primary outcomes:
measure: Chronic success in ADVENT Trial treated subjects compared between treatment groups.
timeFrame: 90 day-3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Grandview Medical Center
state: Alabama
city: Phoenix
country: United States
facility: Banner University Medical Center Phoenix
state: Arizona
city: Burlingame
country: United States
facility: Mills Peninsula Health Services
state: California
city: La Jolla
country: United States
facility: Scripps Memorial Hospital
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Boise
country: United States
facility: St. Lukes Idaho Cardiology Associates
state: Idaho
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital (MGH)
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Kansas City
country: United States
facility: St. Luke's Hospital of Kansas City
state: Missouri
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: New York City
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: Mount Sinai, Icahn School of Medicine
state: New York
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Doylestown
country: United States
facility: Doylestown Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Presbyterian University of Pennsylvania Medical Center
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Pinnacle Health at Harrisburg Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Trident Medical Center
state: South Carolina
city: Nashville
country: United States
facility: St. Thomas Research Institute, LLC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University Health System
state: Virginia
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Vivek Reddy
role: PRINCIPAL_INVESTIGATOR
References: