The Vanderbilt Atrial Fibrillation Ablation Registry (VAFAR)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02404415 |
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Recruitment Status :
Recruiting
First Posted : March 31, 2015
Last Update Posted : March 5, 2024
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Sponsor:
Vanderbilt University
Information provided by (Responsible Party):
M. Benjamin Shoemaker, Vanderbilt University
| Tracking Information | |||||||||
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| First Submitted Date | March 19, 2015 | ||||||||
| First Posted Date | March 31, 2015 | ||||||||
| Last Update Posted Date | March 5, 2024 | ||||||||
| Study Start Date | October 2011 | ||||||||
| Estimated Primary Completion Date | October 2026 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Atrial fibrillation recurrence [ Time Frame: 2 years ] | ||||||||
| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | The Vanderbilt Atrial Fibrillation Ablation Registry | ||||||||
| Official Title | The Vanderbilt Atrial Fibrillation Ablation Registry | ||||||||
| 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. | ||||||||
| Study Type | Observational [Patient Registry] | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | 10 Years | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Adults scheduled to undergo an atrial fibrillation ablation | ||||||||
| Condition | Atrial Fibrillation | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
3000 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | October 2026 | ||||||||
| Estimated Primary Completion Date | October 2026 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion criteria:
Exclusion criteria: 1. None |
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT02404415 | ||||||||
| Other Study ID Numbers | 110881 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product | Not Provided | ||||||||
| IPD Sharing Statement | Not Provided | ||||||||
| Current Responsible Party | M. Benjamin Shoemaker, Vanderbilt University | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor | Vanderbilt University | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Vanderbilt University Medical Center | ||||||||
| Verification Date | March 2024 | ||||||||