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
- Diseases
- Atrial fibrillation
- 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
Sites (30)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sos Cardio Servicoshospitalares Ltda Coordinator of this site? Confirm its status | Florianópolis | Brazil | Unknown status |
| Instituto do Coração do HCFMUSP Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Institut de Cardiologie de Montreal-Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Institut universitaire de cardiologie et de pneumologie de Québec Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Hospital Regional de Concepción Coordinator of this site? Confirm its status | Concepción | Chile | Unknown status |
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Prisma Health Richland Hospital Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| New York Hospital Queens Coordinator of this site? Confirm its status | Flushing | United States | Unknown status |
| Florida Heart Rhythm Specialists, PLLC Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Unknown status |
| University of Texas Medical Branch Coordinator of this site? Confirm its status | Galveston | United States | Unknown status |
| East Carolina University Medical Center Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Pinnacle Health at Harrisburg Hospital Coordinator of this site? Confirm its status | Harrisburg | United States | Unknown status |
| Orion Medical Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| University of Texas Houston Health Science Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| University of Mississippi Medical Center Coordinator of this site? Confirm its status | Jackson | United States | Unknown status |
| Baptist Medical Center Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Mount Sinai Medical Center Coordinator of this site? Confirm its status | Miami Beach | United States | Unknown status |
| Mobile Infirmary Medical Center Coordinator of this site? Confirm its status | Mobile | United States | Unknown status |
| Ochsner Clinic Foundation Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Northwell Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Sentara Norfolk General Hospital Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| Alta Bates Summit Medical Center Coordinator of this site? Confirm its status | Oakland | United States | Unknown status |
| Memorial Health University Medical Center Coordinator of this site? Confirm its status | Savannah | United States | Unknown status |
| Scottsdale Healthcare - Shea Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| Tallahassee Memorial Hospital Coordinator of this site? Confirm its status | Tallahassee | United States | Unknown status |
| AdventHealth Tampa Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Washington Hospital Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.