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NCT06431815Active, not recruiting

ADVENT Post Approval Study

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

Source: ClinicalTrials.gov · Last updated 23 Oct 2026

Brief summary (registry, in English)

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

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
228 (actual)
First submitted
22 May 2024
Start date
25 Sept 2024
Primary completion date
Oct 2028
Lead sponsor
Boston Scientific Corporation
NCT number
NCT06431815

What you commit to

  • Study type: Observational
  • Participants enrolled: 228
  • From 25 Sept 2024 to the primary completion date, Oct 2028
  • 30 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Subjects with any prior left atrium (LA) ablation;

Other

  • Subjects with any known contraindication to an AF ablation or anticoagulation, including those listed in the Instructions For Use (IFU);
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (30)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Sos Cardio Servicoshospitalares Ltda
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FlorianópolisBrazilUnknown status
Instituto do Coração do HCFMUSP
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São PauloBrazilUnknown status
Institut de Cardiologie de Montreal-Hospital
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MontrealCanadaUnknown status
Institut universitaire de cardiologie et de pneumologie de Québec
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QuébecCanadaUnknown status
Hospital Regional de Concepción
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ConcepciónChileUnknown status
Beth Israel Deaconess Medical Center
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BostonUnited StatesUnknown status
Medical University of South Carolina
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CharlestonUnited StatesUnknown status
Prisma Health Richland Hospital
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ColumbiaUnited StatesUnknown status
New York Hospital Queens
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FlushingUnited StatesUnknown status
Florida Heart Rhythm Specialists, PLLC
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Fort LauderdaleUnited StatesUnknown status
University of Texas Medical Branch
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GalvestonUnited StatesUnknown status
East Carolina University Medical Center
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GreenvilleUnited StatesUnknown status
Pinnacle Health at Harrisburg Hospital
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HarrisburgUnited StatesUnknown status
Orion Medical
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HoustonUnited StatesUnknown status
University of Texas Houston Health Science Center
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HoustonUnited StatesUnknown status
University of Mississippi Medical Center
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JacksonUnited StatesUnknown status
Baptist Medical Center
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JacksonvilleUnited StatesUnknown status
Mount Sinai Medical Center
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Miami BeachUnited StatesUnknown status
Mobile Infirmary Medical Center
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MobileUnited StatesUnknown status
Ochsner Clinic Foundation
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New OrleansUnited StatesUnknown status
Northwell Health
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New YorkUnited StatesUnknown status
Columbia University Medical Center
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New YorkUnited StatesUnknown status
Sentara Norfolk General Hospital
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NorfolkUnited StatesUnknown status
Alta Bates Summit Medical Center
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OaklandUnited StatesUnknown status
Memorial Health University Medical Center
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SavannahUnited StatesUnknown status
Scottsdale Healthcare - Shea
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ScottsdaleUnited StatesUnknown status
Tallahassee Memorial Hospital
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TallahasseeUnited StatesUnknown status
AdventHealth Tampa
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TampaUnited StatesUnknown status
Montefiore Medical Center
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The BronxUnited StatesUnknown status
Washington Hospital Center
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Washington D.C.United StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.