Atrial FibrillationVIBRANT-AFNCT05504356
Volunteers to Investigate Best Results for Ablation and Novel Therapies for Atrial Fibrillation
An observational study of Atrial Fibrillation, run by University of California, San Francisco at 1 site in United States.
Trial summary
VIBRANT-AF seeks to: Identify clinically relevant predictors of effectiveness and complications of AF ablation procedures in a prospective, US-based, multi-center, real-world longitudinal study Assess changes in modifiable lifestyle-related exposures influence the effectiveness of AF ablation Determine incidence and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 1,125 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2022to 31 Jul 2027
- How long will I take part?
- 1 Year
- 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 a diagnosis of AF (i.e. new onset AF, paroxysmal AF, persistent AF, Permanent AF), who have recently or will imminently be undergoing AF ablation. Subjects will be at least 18 years of age or older, and be English-speakers, as well as adhere to the inclusion criteria pertaining to access to the Eureka mobile app (owning a smartphone device and cell phone number, email address)
Who may be able to join
- Adults age 18 and older
- Must have a smartphone device (iOS and/or Android) and cell phone number to participate on the mobile app, and will be willing to download the Eureka Research Platform mobile application
- Must have email address to participate on the web portal (accessible on any web-connected device)
- Undergone a catheter ablation procedure for atrial fibrillation in the week prior to recruitment, or have an ablation planned for within a week from recruitment
Who cannot join
- Unable to consent for themselves
- Unable to read, speak, comprehend English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Greg Marcus, greg.marcus@ucsf.edu
About this study
VIBRANT-AF seeks to:
- Identify clinically relevant predictors of effectiveness and complications of AF ablation procedures in a prospective, US-based, multi-center, real-world longitudinal study
- Assess changes in modifiable lifestyle-related exposures influence the effectiveness of AF ablation
- Determine incidence and predictors of complications of AF ablation procedures
Participants will connect with the Eureka Research Platform and answer a series of surveys and activities over a one-year period. They will be asked about lifestyle habits, recurrence of AFib, hospitalizations, and general feelings and emotions.
Read the detailed description
Catheter ablation for Atrial Fibrillation is the most commonly performed cardiac electrophysiology procedure. Although now standard of care in professional society guidelines, recommendations favoring the procedure are predominately based on randomized trials or single-center experiences from high-volume institutions staffed by expert operators. Participants enrolled in those randomized trials are healthier than those undergoing the procedure in the "real world," and the actual experiences of patients throughout the US are not represented by those referred to tertiary-referral centers that most frequently publish their retrospective observations. Although administrative databases provide a glimpse into what happens in the real-world, ICD-9, ICD-10, and CPT codes cannot capture specific procedural approaches or patient perspectives. For this reason, this study aims to leverage the Eureka Research Platform, a digital health infrastructure to enable longitudinal follow-up and ascertainment of patient reported outcomes.
This is a longitudinal, observational cohort study. 15,000 subjects are planned to be enrolled, and will be followed for a period of one year. Subjects will be asked weekly survey questions on weekly habits, complications, medication usage, and hospitalizations. They will have the option to receive AliveCor Kardia devices for remote ECG monitoring, as well as connect their Apple HealthKit data. Surveys will be conducted via the Eureka mobile app.
In conjunction with the Eureka Research Platform, the study will leverage the AF Ablation National Cardiovascular Data Registry (NCDR) run by the American College of Cardiology (ACC). This rapidly growing registry includes comprehensive data regarding patient, procedure, and institution-level characteristics, now includes over 200 institutions around the US, and has already enrolled more than 47,000 patients. However, the registry is limited to data collected during the index procedure visit, without longitudinal follow-up or patient reported outcomes. The study will link the Eureka Research Platform data to NCDR registry data on the index procedure for a subset of participants, allowing for analysis of longitudinal follow-up together with index procedure data.
- Conditions
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Atrial Fibrillation Recurrence
Time to atrial fibrillation, after employing a 3-month blanking period. Atrial Fibrillation Recurrence includes patient-reported symptoms of AF or Kardia-based ECG evidence of AF.
Measured: 1 year
Secondary outcomes (1)
Mean Change in the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Score
Atrial Fibrillation Effect on Quality-of-Life will be measured using the AFEQT, the score ranges from 0 to 100, with higher scores indicating better quality of life
Measured: 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start27 Apr 2022
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
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 Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- 1,125 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Cardiology
- Responsible party
- Sponsor
- Investigators
- Gregory Marcus, MD, MAS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504356
- Sponsor's protocol ID
- P0548846
- Acronym
- VIBRANT-AF
- Status last verified
- Sep 2026
- First submitted
- 15 Aug 2022
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elias A, Holtzman JN, Djomaleu ML, Freeman JV, Natale A, Hsu JC, Tzou WS, Garg L, Dukes JW, Cooper DH, Gionfriddo W, Whitman IR, Isakadze N, Spragg DD, Satti DI, Rosenthal DG, Riles EM, Hills MT, McCall D, Montenegro GC, Oo HH, Lowe DA, Gerstenfeld EP, Moss JD, Dewland TA, Hsia HH, Lee RJ, Tseng ZH, Vedantham V, Marcus GM. Feasibility of Self-Reported Surveillance After Catheter Ablation for Atrial Fibrillation Using A Mobile Application. JACC Adv. 2026 Mar;5(3):102625. doi: 10.1016/j.jacadv.2026.102625.
PubMed 41906612
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volunteers to Investigate Best Results for Ablation and Novel Therapies for Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05504356
- Acronym / sponsor ID
- VIBRANT-AF / P0548846
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,125 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- American College of Cardiology
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 17 Aug 2022 (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.
VIBRANT-AF seeks to:
- Identify clinically relevant predictors of effectiveness and complications of AF ablation procedures in a prospective, US-based, multi-center, real-world longitudinal study
- Assess changes in modifiable lifestyle-related exposures influence the effectiveness of AF ablation
- Determine incidence and predictors of complications of AF ablation procedures
Participants will connect with the Eureka Research Platform and answer a series of surveys and activities over a one-year period. They will be asked about lifestyle habits, recurrence of AFib, hospitalizations, and general feelings and emotions.
Detailed description
Catheter ablation for Atrial Fibrillation is the most commonly performed cardiac electrophysiology procedure. Although now standard of care in professional society guidelines, recommendations favoring the procedure are predominately based on randomized trials or single-center experiences from high-volume institutions staffed by expert operators. Participants enrolled in those randomized trials are healthier than those undergoing the procedure in the "real world," and the actual experiences of patients throughout the US are not represented by those referred to tertiary-referral centers that most frequently publish their retrospective observations. Although administrative databases provide a glimpse into what happens in the real-world, ICD-9, ICD-10, and CPT codes cannot capture specific procedural approaches or patient perspectives. For this reason, this study aims to leverage the Eureka Research Platform, a digital health infrastructure to enable longitudinal follow-up and ascertainment of patient reported outcomes.
This is a longitudinal, observational cohort study. 15,000 subjects are planned to be enrolled, and will be followed for a period of one year. Subjects will be asked weekly survey questions on weekly habits, complications, medication usage, and hospitalizations. They will have the option to receive AliveCor Kardia devices for remote ECG monitoring, as well as connect their Apple HealthKit data. Surveys will be conducted via the Eureka mobile app.
In conjunction with the Eureka Research Platform, the study will leverage the AF Ablation National Cardiovascular Data Registry (NCDR) run by the American College of Cardiology (ACC). This rapidly growing registry includes comprehensive data regarding patient, procedure, and institution-level characteristics, now includes over 200 institutions around the US, and has already enrolled more than 47,000 patients. However, the registry is limited to data collected during the index procedure visit, without longitudinal follow-up or patient reported outcomes. The study will link the Eureka Research Platform data to NCDR registry data on the index procedure for a subset of participants, allowing for analysis of longitudinal follow-up together with index procedure data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with a diagnosis of AF (i.e. new onset AF, paroxysmal AF, persistent AF, Permanent AF), who have recently or will imminently be undergoing AF ablation. Subjects will be at least 18 years of age or older, and be English-speakers, as well as adhere to the inclusion criteria pertaining to access to the Eureka mobile app (owning a smartphone device and cell phone number, email address)
Key inclusion criteria (4 listed)
- Adults age 18 and older
- Must have a smartphone device (iOS and/or Android) and cell phone number to participate on the mobile app, and will be willing to download the Eureka Research Platform mobile application
- Must have email address to participate on the web portal (accessible on any web-connected device)
- Undergone a catheter ablation procedure for atrial fibrillation in the week prior to recruitment, or have an ablation planned for within a week from recruitment
Key exclusion criteria (2 listed)
- Unable to consent for themselves
- Unable to read, speak, comprehend English
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
Time to Atrial Fibrillation Recurrence
Time frame: 1 year
Time to atrial fibrillation, after employing a 3-month blanking period. Atrial Fibrillation Recurrence includes patient-reported symptoms of AF or Kardia-based ECG evidence of AF.
1 secondary outcome
Mean Change in the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Score
Time frame: 6 months, 1 year
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 5 Oct 2026.
- Derived from this study: PubMed 41906612Elias A, Holtzman JN, Djomaleu ML, Freeman JV, Natale A, Hsu JC, Tzou WS, Garg L, Dukes JW, Cooper DH, Gionfriddo W, Whitman IR, Isakadze N, Spragg DD, Satti DI, Rosenthal DG, Riles EM, Hills MT, McCall D, Montenegro GC, Oo HH, Lowe DA, Gerstenfeld EP, Moss JD, Dewland TA, Hsia HH, Lee RJ, Tseng ZH, Vedantham V, Marcus GM. Feasibility of Self-Reported Surveillance After Catheter Ablation for Atrial Fibrillation Using A Mobile Application. JACC Adv. 2026 Mar;5(3):102625. doi: 10.1016/j.jacadv.2026.102625.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
Gregory Marcus, MD, MAS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by University of California, San Francisco at 1 site 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 2 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: looking for participants now, as of the sponsor's last update on 5 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 1 site 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?
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?
Contact Bella Peña, BA (415-502-3053, bella.pena@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Atrial Fibrillation Recurrence (time frame: 1 year). 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 NCT05504356, 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 5 Oct 2026.