Paroxysmal Atrial FibrillationADVENTPASNCT06431815
ADVENT Post Approval Study
An observational study of Paroxysmal Atrial Fibrillation, run by Boston Scientific Corporation at 30 sites in 4 countries.
Trial summary
The ADVENT Post Approval Study (PAS) is a prospective, global, multicenter, observational study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- FARAPULSE™ Pulsed Field Ablation System
- Type of treatment
- Medical device
- How many people
- 228 participants
- Where
- 30 sitesin 4 countries
- Study dates
- 25 Sep 2024to Oct 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
30 sites in 4 countries.
30 sites in 4 countries
United States25 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Medical University of South Carolina
Charleston, South Carolina, 29425
Prisma Health Richland Hospital
Columbia, South Carolina, 29203
New York Hospital Queens
Flushing, New York, 11355
Florida Heart Rhythm Specialists, PLLC
Fort Lauderdale, Florida, 33308
University of Texas Medical Branch
Galveston, Texas, 77555-0737
East Carolina University Medical Center
Greenville, North Carolina, 27834
Pinnacle Health at Harrisburg Hospital
Harrisburg, Pennsylvania, 17104
University of Texas Houston Health Science Center
Houston, Texas, 77030
Orion Medical
Houston, Texas, 77034
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4504
Baptist Medical Center
Jacksonville, Florida, 32207
Mount Sinai Medical Center
Miami Beach, Florida, 33140
Mobile Infirmary Medical Center
Mobile, Alabama, 36608
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Columbia University Medical Center
New York, New York, 10019
Northwell Health
New York, New York, 10075
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Alta Bates Summit Medical Center
Oakland, California, 94609
Memorial Health University Medical Center
Savannah, Georgia, 31404
Scottsdale Healthcare - Shea
Scottsdale, Arizona, 85258
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308
AdventHealth Tampa
Tampa, Florida, 33613
Montefiore Medical Center
The Bronx, New York, 10461
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Brazil2 sites
Sos Cardio Servicoshospitalares Ltda
Florianópolis, Santa Catarina, 88030-000
Instituto do Coração do HCFMUSP
São Paulo, São Paulo, 05403-900
Canada2 sites
Institut de Cardiologie de Montreal-Hospital
Montreal, Quebec, H1T 1C8
Institut universitaire de Cardiologie et de Pneumologie de Quebec
Québec, Quebec, G1V 4G5
About this study
Official title: 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.
Read the 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).
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- FARAPULSE™ Pulsed Field Ablation System
- Keywords
- Pulsed Field Ablation, PFA, Pulmonary Vein Isolation, PVI, Ablation, Atrial Fibrillation, AF
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FARAPULSE™ Pulsed Field Ablation SystemDevice
Also called FARAWAVE™ Pulsed Field Ablation Catheter
De-novo pulmonary vein isolation (PVI) will be performed with the FARAPULSE Pulsed Field Ablation (PFA) System.
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite incidence of patients with procedure-related and device-related serious adverse events at 7-Days and 12-months post-Index Procedure.
- 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)
Measured: 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.
- 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)
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start25 Sep 2024
- Primary completionOct 2028 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stavros E Mountantonakis, MD, MBA, Principal investigator, Northwell Health, Lenox Hill Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06431815
- Sponsor's protocol ID
- PF304
- Acronym
- ADVENTPAS
- Status last verified
- Oct 2026
- First submitted
- 22 May 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-site Safety and Effectiveness Post-Approval Study of FARAPULSE Pulsed Field Ablation in Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06431815
- Acronym / sponsor ID
- ADVENTPAS / PF304
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- Pulsed Field Ablation, PFA, Pulmonary Vein Isolation, PVI, Ablation, Atrial Fibrillation, AF
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 29 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ADVENT Post Approval Study (PAS) is a prospective, global, multicenter, observational study.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FARAPULSE™ Pulsed Field Ablation SystemAlso: FARAWAVE™ Pulsed Field Ablation CatheterDe-novo pulmonary vein isolation (PVI) will be performed with the FARAPULSE Pulsed Field Ablation (PFA) System. | Device | – |
Primary outcome
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: Undecided. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stavros E Mountantonakis, MD, MBA principal investigator
Northwell Health, Lenox Hill Hospital
30 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paroxysmal Atrial Fibrillation, run by Boston Scientific Corporation at 30 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Brazil, Canada, Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.