ADVENT Post Approval Study (ADVENTPAS)

August 26, 2026 updated by: Boston Scientific Corporation

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Actual)

228

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Santa Catarina
      • Florianópolis, Santa Catarina, Brazil, 88030-000
        • Sos Cardio Servicoshospitalares Ltda
    • São Paulo
      • São Paulo, São Paulo, Brazil, 05403-900
        • Instituto do Coração do HCFMUSP
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Institut de Cardiologie de Montreal-Hospital
      • Québec, Quebec, Canada, G1V 4G5
        • Institut Universitaire de Cardiologie et de Pneumologie de Quebec
  • Chile
    • Biobio
      • Concepción, Biobio, Chile, 4070022
        • Hospital Regional de Concepcion
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Mobile Infirmary Medical Center
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Scottsdale Healthcare - Shea
    • California
      • Oakland, California, United States, 94609
        • Alta Bates Summit Medical Center
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Washington Hospital Center
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Florida Heart Rhythm Specialists, PLLC
      • Jacksonville, Florida, United States, 32207
        • Baptist Medical Center
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Memorial Hospital
      • Tampa, Florida, United States, 33613
        • AdventHealth Tampa
    • Georgia
      • Savannah, Georgia, United States, 31404
        • Memorial Health University Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Mississippi
      • Jackson, Mississippi, United States, 39216-4504
        • University of Mississippi Medical Center
    • New York
      • Flushing, New York, United States, 11355
        • New York Hospital Queens
      • New York, New York, United States, 10019
        • Columbia University Medical Center
      • New York, New York, United States, 10075
        • Northwell Health
      • The Bronx, New York, United States, 10461
        • Montefiore Medical Center
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • East Carolina University Medical Center
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17104
        • Pinnacle Health at Harrisburg Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Columbia, South Carolina, United States, 29203
        • Prisma Health Richland Hospital
    • Texas
      • Galveston, Texas, United States, 77555-0737
        • University of Texas Medical Branch
      • Houston, Texas, United States, 77030
        • University of Texas Houston Health Science Center
      • Houston, Texas, United States, 77034
        • Orion Medical
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General Hospital

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite incidence of patients with procedure-related and device-related serious adverse events at 7-Days and 12-months post-Index Procedure.
Time Frame: 12 Months

  • Early Onset: Acute primary safety endpoint events, events occurring up to 7 days post-Index Procedure or hospital discharge, whichever is later including serious procedure-related and device-related adverse events.

    • Death
    • Myocardial infarction (MI)
    • Persistent phrenic nerve palsy
    • Stroke/Cerebrovascular accident (CVA)
    • Transient ischemic attack (TIA)
    • Peripheral or organ thromboembolism
    • Cardiac tamponade / perforation
    • Pericarditis
    • Pulmonary edema
    • Serious vascular access complications
    • Heart block
    • Gastric motility / pyloric spasm disorders
    • Severe hemolysis with subsequent renal injury or significant anemia
  • Late Onset: Either of the following with an onset date any time through 12-month post-Index Procedure:
  • Atrial esophageal fistula
  • Pulmonary vein stenosis (≥ 70% reduction of diameter)
12 Months
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.
Time Frame: 12 Months

- Acute Procedural Success: Acute procedural success is defined as isolation of all clinically relevant pulmonary veins or anatomical equivalents using the FARAPULSE Pulsed Field Ablation System only

AND

- Chronic Success, defined as freedom from the following:

After the Blanking Period up to the 12-Month Follow-up visit:

  • Occurrence of any Detectable AF, AFL, AT
  • ≥ 30 seconds in duration from any approved clinical recording devices considered standard of care at the study center (excluding implantable loop recorders) or
  • ≥ 10-second of continuous AF, AFL or AT documented on any 12-lead ECG
  • Following interventions:
  • Any cardioversion for AF, AFL or AT
  • Prescribed a higher dose of any failed Class I or III Antiarrhythmic Drug (AAD) documented at baseline or any new Class I or III AAD
  • Re-ablation for AF, AFL or AT (other than for cavotricuspid isthmus (CTI)-dependent flutter only)
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: Stavros E Mountantonakis, MD, MBA, Northwell Health, Lenox Hill Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2024

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2029

Study Registration Dates

First Submitted

May 22, 2024

First Submitted That Met QC Criteria

May 22, 2024

First Posted (Actual)

May 29, 2024

Study Record Updates

Last Update Posted (Actual)

August 28, 2026

Last Update Submitted That Met QC Criteria

August 26, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PF304

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

No requests for study data have been made at this time, however Boston's Scientific's policy on data sharing can be found at http://www.bostonscientific.com/en-US/data-sharing-requests.html

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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