The Vanderbilt Atrial Fibrillation Ablation Registry

NCT ID: NCT02404415

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2028-10-31

Brief 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. 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.

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Age >18 years

2. Able to give written, informed consent

3. Scheduled for an ablation procedure to treat atrial fibrillation

Exclusion Criteria

1. None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

M. Benjamin Shoemaker

Clinical Instructor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Moore B Shoemaker, MD, MSCI

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Moore B Shoemaker, MD, MSCI

Role: CONTACT

615 322 ext. 2318

Diane M Crawford, RN

Role: CONTACT

Diane.m.crawford@vanderbilt.edu

615-936-6069

Facility Contacts

Diane M Crawford, RN

Role: primary

Diane.m.crawford@vumc.org

615-936-6069

Moore B Shoemaker, MD, MSCI

Role: backup

moore.b.shoemaker@vumc.org

615 322-2318

References

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.

Reference Type: RESULT

PMID: 23168290 (View on PubMed)

Benjamin 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.

Reference Type: RESULT

PMID: 23178686 (View on PubMed)

Shoemaker 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.

Reference Type: RESULT

PMID: 24214203 (View on PubMed)

Shoemaker 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.

Reference Type: RESULT

PMID: 25684755 (View on PubMed)

Farrell 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.

Reference Type: DERIVED

PMID: 28880943 (View on PubMed)

Other Identifiers

110881

Identifier Type: -

Identifier Source: org_study_id