Paroxysmal Atrial FibrillationADVENT LTONCT06526546
ADVENT Trial Long Term Outcomes Evaluating Atrial Fibrillation Progression Study
An observational study of Paroxysmal Atrial Fibrillation, run by Boston Scientific Corporation at 25 sites in United States.
Trial summary
The (ADVENT LTO) is an observational, non-significant risk study to assess the progression of atrial fibrillation in subjects who received ablation treatment with either the FARAPULSE Pulsed Field Ablation System or thermal ablation in the ADVENT Trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- How many people
- 364 participants
- Where
- 25 sitesUnited States
- Study dates
- 31 Oct 2024to 8 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Study eligibility criteria are defined below. Subjects who became deceased after completion of the ADVENT Trial will remain eligible for chart review data upon consent of a legally authorized representative (LAR). Subjects unable to complete the 7-day Holter monitor may consent to participate in the chart review portion only.
Who may be able to join
- Subjects who meet all of the following criteria may be given consideration for inclusion in this clinical investigation.
- Subjects who were enrolled, randomized and treated for paroxysmal atrial fibrillation, classified as Modified Intention-to-Treat subjects, and completed the 12-Month Follow-Up in the FARAPULSE ADVENT Trial (CIP CS0934; NCT04612244).
- Subjects or legally authorized representatives who are willing and capable of providing informed consent.
- Subjects who are willing to comply with the protocol requirements.
Who cannot join
- There are no exclusion criteria for this study.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Emory University Hospital
Atlanta, Georgia, 30322
Texas Cardiac Arrhythmia Research
Austin, Texas, 78705
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Grandview Medical Center
Birmingham, Alabama, 35243
St. Lukes Idaho Cardiology Associates
Boise, Idaho, 83702
Massachusetts General Hospital (MGH)
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Mills Peninsula Health Services
Burlingame, California, 94010
Trident Medical Center
Charleston, South Carolina, 29406
Medical University of South Carolina
Charleston, South Carolina, 29425
Doylestown Hospital
Doylestown, Pennsylvania, 18901
St. Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Scripps Memorial Hospital
La Jolla, California, 92037
St. Thomas Research Institute, LLC
Nashville, Tennessee, 37205
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Mount Sinai, Icahn School of Medicine
New York, New York, 10029
Northwell Health
New York, New York, 10075
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
Presbyterian University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Virginia Commonwealth University Health System
Richmond, Virginia, 23219
University of California, San Francisco
San Francisco, California, 94143-0628
Washington Hospital Center
Washington D.C., District of Columbia, 20010-2975
Pinnacle Health at Harrisburg Hospital
Wormleysburg, Pennsylvania, 17043
About this study
Official title: ADVENT Trial Long Term Outcomes Evaluating Atrial Fibrillation Progression (ADVENT LTO Study)
The (ADVENT LTO) is an observational, non-significant risk study to assess the progression of atrial fibrillation in subjects who received ablation treatment with either the FARAPULSE Pulsed Field Ablation System or thermal ablation in the ADVENT Trial.
Read the detailed description
This study is an observational, non-significant risk study. Subjects who participated in the FARAPULSE ADVENT Trial (NCT04612244) will be approached for participation.
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- Persistent Atrial Fibrillation, Pulsed Field Ablation, Cardiovascular Heart Diseases, Antiarrhythmic Anticoagulation, Cardiac monitor, Atrial Fibrillation, Atrial Flutter, Atrial Tachycardia
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic success in ADVENT Trial treated subjects compared between treatment groups.
Occurrence of any of the following between the end of the Blanking Period (Day 90) in the ADVENT Trial through completion of follow-up in the ADVENT LTO study:
Detectable AF, AFL+, or AT
- ≥ 30 seconds in duration as adjudicated within the ADVENT Trial
- Investigator assessed ≥ 30 seconds in duration from any approved clinical recording devices considered standard of care* at the study center post-ADVENT Trial completion
- ≥ 30 seconds in duration recorded on the Holter monitor collected during the ADVENT Trial and the 3-4 Year Holter Monitor.
- ≥ 10-second of continuous AF, AFL or AT documented on any 12-lead ECG
Any Cardioversion for AF, AFL, or AT
Re-ablation for AF, AFL, or AT
Measured: 90 day-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start31 Oct 2024
- Primary completion8 Dec 2025
- Study completion8 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vivek Reddy, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526546
- Sponsor's protocol ID
- PF116
- Acronym
- ADVENT LTO
- Status last verified
- Feb 2026
- First submitted
- 25 Jul 2024
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- 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
Publications
Reddy VY, Gerstenfeld EP, Mountantonakis SE, Patel C, Ellenbogen KA, Harding JD, Gibson DN, Natale A, Waks JW, Calkins H, Gupta SK, Woods CE, Whang W, Daccarett M, Cuoco FA, Delurgio DB, Richards E, Martens MD, Sutton B, Mansour M; ADVENT-LTO Study Investigators. Pulsed field ablation versus conventional thermal ablation for paroxysmal atrial fibrillation: 4-year outcomes in the ADVENT-LTO study. Nat Med. 2026 Apr;32(4):1444-1453. doi: 10.1038/s41591-026-04246-4. Epub 2026 Feb 6.
PubMed 41652117
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADVENT Trial Long Term Outcomes Evaluating Atrial Fibrillation Progression (ADVENT LTO Study)
- ClinicalTrials.gov ID
- NCT06526546
- Acronym / sponsor ID
- ADVENT LTO / PF116
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- Persistent Atrial Fibrillation, Pulsed Field Ablation, Cardiovascular Heart Diseases, Antiarrhythmic Anticoagulation, Cardiac monitor, Atrial Fibrillation, Atrial Flutter, Atrial Tachycardia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 8 Dec 2025 (actual)
- Study completion
- 8 Dec 2025 (actual)
- First posted
- 30 Jul 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 LTO) is an observational, non-significant risk study to assess the progression of atrial fibrillation in subjects who received ablation treatment with either the FARAPULSE Pulsed Field Ablation System or thermal ablation in the ADVENT Trial.
Detailed description
This study is an observational, non-significant risk study. Subjects who participated in the FARAPULSE ADVENT Trial (NCT04612244) will be approached for participation.
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
- Study eligibility criteria are defined below. Subjects who became deceased after completion of the ADVENT Trial will remain eligible for chart review data upon consent of a legally authorized representative (LAR). Subjects unable to complete the 7-day Holter monitor may consent to participate in the chart review portion only.
Key inclusion criteria (4 listed)
- Subjects who meet all of the following criteria may be given consideration for inclusion in this clinical investigation.
- Subjects who were enrolled, randomized and treated for paroxysmal atrial fibrillation, classified as Modified Intention-to-Treat subjects, and completed the 12-Month Follow-Up in the FARAPULSE ADVENT Trial (CIP CS0934; NCT04612244).
- Subjects or legally authorized representatives who are willing and capable of providing informed consent.
- Subjects who are willing to comply with the protocol requirements.
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Chronic success in ADVENT Trial treated subjects compared between treatment groups.
Time frame: 90 day-3 years
Occurrence of any of the following between the end of the Blanking Period (Day 90) in the ADVENT Trial through completion of follow-up in the ADVENT LTO study: Detectable AF, AFL+, or AT * ≥ 30 seconds in duration as adjudicated within the ADVENT Trial * Investigator assessed ≥ 30 seconds in duration from any approved clinical recording devices considered standard of care* at the study center post-ADVENT Trial completion * ≥ 30 seconds in duration recorded on the Holter monitor collected during the ADVENT Trial and the 3-4 Year Holter Monitor. * ≥ 10-second of continuous AF, AFL or AT documented on any 12-lead ECG Any Cardioversion for AF, AFL, or AT Re-ablation for AF, AFL, or AT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Derived from this study: PubMed 41652117Reddy VY, Gerstenfeld EP, Mountantonakis SE, Patel C, Ellenbogen KA, Harding JD, Gibson DN, Natale A, Waks JW, Calkins H, Gupta SK, Woods CE, Whang W, Daccarett M, Cuoco FA, Delurgio DB, Richards E, Martens MD, Sutton B, Mansour M; ADVENT-LTO Study Investigators. Pulsed field ablation versus conventional thermal ablation for paroxysmal atrial fibrillation: 4-year outcomes in the ADVENT-LTO study. Nat Med. 2026 Apr;32(4):1444-1453. doi: 10.1038/s41591-026-04246-4. Epub 2026 Feb 6.
- 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.
Vivek Reddy principal investigator
MOUNT SINAI HOSPITAL
25 sites in 1 country: 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 25 sites in United States.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Chronic success in ADVENT Trial treated subjects compared between treatment groups. (time frame: 90 day-3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06526546, which also lists 1 linked publication.
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 2 Mar 2026.