ADVENT Post-Approval Study

Description

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

Conditions

Paroxysmal Atrial Fibrillation

Study Overview

Study Details

Study overview

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

Prospective, Multi-site Safety and Effectiveness Post-Approval Study of FARAPULSE Pulsed Field Ablation in Paroxysmal Atrial Fibrillation

ADVENT Post-Approval Study

Condition
Paroxysmal Atrial Fibrillation
Intervention / Treatment

-

Contacts and Locations

Mobile

Mobile Infirmary Medical Center, Mobile, Alabama, United States, 36608

Scottsdale

Scottsdale Healthcare - Shea, Scottsdale, Arizona, United States, 85258

Oakland

Alta Bates Summit Medical Center, Oakland, California, United States, 94609

Washington

Washington Hospital Center, Washington, District of Columbia, United States, 20010

Fort Lauderdale

Florida Heart Rhythm Specialists, PLLC, Fort Lauderdale, Florida, United States, 33308

Jacksonville

Baptist Medical Center, Jacksonville, Florida, United States, 32207

Miami Beach

Mount Sinai Medical Center, Miami Beach, Florida, United States, 33140

Tallahassee

Tallahassee Memorial Hospital, Tallahassee, Florida, United States, 32308

Tampa

AdventHealth Tampa, Tampa, Florida, United States, 33613

Savannah

Memorial Health University Medical Center, Savannah, Georgia, United States, 31404

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Boston Scientific Corporation,

Stavros E Mountantonakis, MD, MBA, PRINCIPAL_INVESTIGATOR, Northwell Health, Lenox Hill Hospital

Study Record Dates

2029-10