Atrial FibrillationVAFARNCT02404415
The Vanderbilt Atrial Fibrillation Ablation Registry
An observational study of Atrial Fibrillation, run by Vanderbilt University at 1 site in United States.
Trial summary
The Vanderbilt Atrial Fibrillation Ablation registry (VAFAR) is a prospective clinical and genetic biorepository that systematically enrolls patients undergoing atrial fibrillation (AF) ablation. The registry was started in 2011 and has greater than 1000 AF ablation records with stored blood and DNA samples. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 2,478 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Oct 2028
- How long will I take part?
- 10 Years
- 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: Adults scheduled to undergo an atrial fibrillation ablation
Who may be able to join
- Age >18 years
- Able to give written, informed consent
- Scheduled for an ablation procedure to treat atrial fibrillation
Who cannot join
- 1. None
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
The Vanderbilt Atrial Fibrillation Ablation registry (VAFAR) is a prospective clinical and genetic biorepository that systematically enrolls patients undergoing atrial fibrillation (AF) ablation. The registry was started in 2011 and has greater than 1000 AF ablation records with stored blood and DNA samples. The goals of VAFAR are to: 1) identify clinical, genetic, and serological predictors of response to AF ablation in order to improve patient selection, and 2) to provide a resource for translational research investigating the electrophysiologic mechanisms of AF pathogenesis.
Read the detailed description
The study population consists of patients at least 18 years of age who are scheduled for AF ablation at Vanderbilt University. Data recorded at enrollment includes a detailed past medical history and measurements from pre-ablation imaging (cardiac MRI or CT). At the time of ablation, a blood sample is collected for storage of plasma/serum and extraction of DNA, and details of the ablation procedure are recorded. Post-ablation monitoring for arrhythmia recurrence is performed according to a standard clinical follow-up schedule at 3, 6, and 12-months. ECG's are performed at each follow-up visit along with placement of an ambulatory ECG-monitor. At 6-months post-ablation, cardiac imaging with a repeat cardiac MRI or CT is performed.
- Conditions
- Atrial Fibrillation
- Keywords
- catheter ablation, genomics
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation recurrence
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startOct 2011
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- 2,478 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Davogustto, Vanderbilt University
- Investigators
- Moore B Shoemaker, MD, MSCI, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404415
- Sponsor's protocol ID
- 110881
- Acronym
- VAFAR
- Status last verified
- Apr 2026
- First submitted
- 19 Mar 2015
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shoemaker MB, Muhammad R, Farrell M, Parvez B, White BW, Streur M, Stubblefield T, Rytlewski J, Parvathaneni S, Nagarakanti R, Roden DM, Saavedra P, Ellis C, Whalen SP, Darbar D. Relation of morbid obesity and female gender to risk of procedural complications in patients undergoing atrial fibrillation ablation. Am J Cardiol. 2013 Feb 1;111(3):368-73. doi: 10.1016/j.amjcard.2012.10.013. Epub 2012 Nov 17.
PubMed 23168290Benjamin Shoemaker M, Muhammad R, Parvez B, White BW, Streur M, Song Y, Stubblefield T, Kucera G, Blair M, Rytlewski J, Parvathaneni S, Nagarakanti R, Saavedra P, Ellis CR, Patrick Whalen S, Roden DM, Darbar R D. Common atrial fibrillation risk alleles at 4q25 predict recurrence after catheter-based atrial fibrillation ablation. Heart Rhythm. 2013 Mar;10(3):394-400. doi: 10.1016/j.hrthm.2012.11.012. Epub 2012 Nov 23.
PubMed 23178686Shoemaker MB, Gidfar S, Pipilas DC, Tamboli RA, Savio Galimberti E, Williams DB, Clements RH, Darbar D. Prevalence and predictors of atrial fibrillation among patients undergoing bariatric surgery. Obes Surg. 2014 Apr;24(4):611-6. doi: 10.1007/s11695-013-1123-8.
PubMed 24214203Shoemaker MB, Bollmann A, Lubitz SA, Ueberham L, Saini H, Montgomery J, Edwards T, Yoneda Z, Sinner MF, Arya A, Sommer P, Delaney J, Goyal SK, Saavedra P, Kanagasundram A, Whalen SP, Roden DM, Hindricks G, Ellis CR, Ellinor PT, Darbar D, Husser D. Common genetic variants and response to atrial fibrillation ablation. Circ Arrhythm Electrophysiol. 2015 Apr;8(2):296-302. doi: 10.1161/CIRCEP.114.001909. Epub 2015 Feb 14.
PubMed 25684755El-Harasis MA, Yoneda ZT, Anderson KC, Ye F, Quintana JA, Martinez-Parachini JR, Jackson GG, Varghese BT, Crawford DM, Sun L, Williams HL, O'Neill MJ, Davogustto GE, Laws JL, Murphy BS, Tomasek K, Su YR, McQuillen E, Metz E, Smith C, Stubbs D, Grauherr DD, Wells QS, Michaud GF, Saavedra P, Carlos Estrada J, Richardson TD, Shen ST, Kanagasundram AN, Montgomery JA, Tandri H, Ellis CR, Crossley GH, Kannankeril PJ, Stevenson LW, Stevenson WG, Lubitz SA, Ellinor PT, Roden DM, Shoemaker MB. Ablation for Atrial Fibrillation in Patients With Rare Pathogenic Variants in Cardiomyopathy and Arrhythmia Genes. JACC Clin Electrophysiol. 2024 Nov;10(11):2359-2370. doi: 10.1016/j.jacep.2024.06.035. Epub 2024 Sep 4.
PubMed 39243256Farrell M, Yoneda Z, Montgomery J, Crawford D, Wray LL, Xu M, Kolek MJ, Richardson T, Lugo R, Metawee M, Michaud G, Estrada JC, Saavedra P, Shen S, Kanagasundram A, Ellis CR, Crossley G, Roden D, Shoemaker MB. Non-pulmonary vein mediated atrial fibrillation: A novel sub-phenotype. PLoS One. 2017 Sep 7;12(9):e0184354. doi: 10.1371/journal.pone.0184354. eCollection 2017.
PubMed 28880943
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Vanderbilt Atrial Fibrillation Ablation Registry
- ClinicalTrials.gov ID
- NCT02404415
- Acronym / sponsor ID
- VAFAR / 110881
- Conditions
- Atrial Fibrillation
- Keywords
- catheter ablation, genomics
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,478 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 31 Mar 2015 (estimated)
- 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 Vanderbilt Atrial Fibrillation Ablation registry (VAFAR) is a prospective clinical and genetic biorepository that systematically enrolls patients undergoing atrial fibrillation (AF) ablation. The registry was started in 2011 and has greater than 1000 AF ablation records with stored blood and DNA samples. The goals of VAFAR are to: 1) identify clinical, genetic, and serological predictors of response to AF ablation in order to improve patient selection, and 2) to provide a resource for translational research investigating the electrophysiologic mechanisms of AF pathogenesis.
Detailed description
The study population consists of patients at least 18 years of age who are scheduled for AF ablation at Vanderbilt University. Data recorded at enrollment includes a detailed past medical history and measurements from pre-ablation imaging (cardiac MRI or CT). At the time of ablation, a blood sample is collected for storage of plasma/serum and extraction of DNA, and details of the ablation procedure are recorded. Post-ablation monitoring for arrhythmia recurrence is performed according to a standard clinical follow-up schedule at 3, 6, and 12-months. ECG's are performed at each follow-up visit along with placement of an ambulatory ECG-monitor. At 6-months post-ablation, cardiac imaging with a repeat cardiac MRI or CT is performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults scheduled to undergo an atrial fibrillation ablation
Key inclusion criteria (3 listed)
- Age >18 years
- Able to give written, informed consent
- Scheduled for an ablation procedure to treat atrial fibrillation
Key exclusion criteria (1 listed)
- 1. None
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
Atrial fibrillation recurrence
Time frame: 2 years
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 27 Apr 2026.
- Results publication: PubMed 23168290Shoemaker MB, Muhammad R, Farrell M, Parvez B, White BW, Streur M, Stubblefield T, Rytlewski J, Parvathaneni S, Nagarakanti R, Roden DM, Saavedra P, Ellis C, Whalen SP, Darbar D. Relation of morbid obesity and female gender to risk of procedural complications in patients undergoing atrial fibrillation ablation. Am J Cardiol. 2013 Feb 1;111(3):368-73. doi: 10.1016/j.amjcard.2012.10.013. Epub 2012 Nov 17.
- Results publication: PubMed 23178686Benjamin Shoemaker M, Muhammad R, Parvez B, White BW, Streur M, Song Y, Stubblefield T, Kucera G, Blair M, Rytlewski J, Parvathaneni S, Nagarakanti R, Saavedra P, Ellis CR, Patrick Whalen S, Roden DM, Darbar R D. Common atrial fibrillation risk alleles at 4q25 predict recurrence after catheter-based atrial fibrillation ablation. Heart Rhythm. 2013 Mar;10(3):394-400. doi: 10.1016/j.hrthm.2012.11.012. Epub 2012 Nov 23.
- Results publication: PubMed 24214203Shoemaker MB, Gidfar S, Pipilas DC, Tamboli RA, Savio Galimberti E, Williams DB, Clements RH, Darbar D. Prevalence and predictors of atrial fibrillation among patients undergoing bariatric surgery. Obes Surg. 2014 Apr;24(4):611-6. doi: 10.1007/s11695-013-1123-8.
- Results publication: PubMed 25684755Shoemaker MB, Bollmann A, Lubitz SA, Ueberham L, Saini H, Montgomery J, Edwards T, Yoneda Z, Sinner MF, Arya A, Sommer P, Delaney J, Goyal SK, Saavedra P, Kanagasundram A, Whalen SP, Roden DM, Hindricks G, Ellis CR, Ellinor PT, Darbar D, Husser D. Common genetic variants and response to atrial fibrillation ablation. Circ Arrhythm Electrophysiol. 2015 Apr;8(2):296-302. doi: 10.1161/CIRCEP.114.001909. Epub 2015 Feb 14.
- Derived from this study: PubMed 39243256El-Harasis MA, Yoneda ZT, Anderson KC, Ye F, Quintana JA, Martinez-Parachini JR, Jackson GG, Varghese BT, Crawford DM, Sun L, Williams HL, O'Neill MJ, Davogustto GE, Laws JL, Murphy BS, Tomasek K, Su YR, McQuillen E, Metz E, Smith C, Stubbs D, Grauherr DD, Wells QS, Michaud GF, Saavedra P, Carlos Estrada J, Richardson TD, Shen ST, Kanagasundram AN, Montgomery JA, Tandri H, Ellis CR, Crossley GH, Kannankeril PJ, Stevenson LW, Stevenson WG, Lubitz SA, Ellinor PT, Roden DM, Shoemaker MB. Ablation for Atrial Fibrillation in Patients With Rare Pathogenic Variants in Cardiomyopathy and Arrhythmia Genes. JACC Clin Electrophysiol. 2024 Nov;10(11):2359-2370. doi: 10.1016/j.jacep.2024.06.035. Epub 2024 Sep 4.
- Derived from this study: PubMed 28880943Farrell M, Yoneda Z, Montgomery J, Crawford D, Wray LL, Xu M, Kolek MJ, Richardson T, Lugo R, Metawee M, Michaud G, Estrada JC, Saavedra P, Shen S, Kanagasundram A, Ellis CR, Crossley G, Roden D, Shoemaker MB. Non-pulmonary vein mediated atrial fibrillation: A novel sub-phenotype. PLoS One. 2017 Sep 7;12(9):e0184354. doi: 10.1371/journal.pone.0184354. eCollection 2017.
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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.
Moore B Shoemaker, MD, MSCI principal investigator
Vanderbilt University
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 Vanderbilt University 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 3 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: under way, not looking for participants, as of the sponsor's last update on 27 Apr 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?
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?
Atrial fibrillation recurrence (time frame: 2 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 NCT02404415, which also lists 6 linked publications.
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 27 Apr 2026.