DIAL-F
Mild Cognitive Impairment (MCI) in Patients With Atrial Fibrillation (AF), Trajectories of the Progression of MCI and Factors Associated With the Progression
Sponsor study identifier
observational
888
1 country
1
Study Start
July 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This study aims to compare the incidence of new-onset cognitive impairments and change in existing impairment status between AF patients undergoing either catheter ablation or remaining on anti-arrhythmic drugs (AAD) as assessed by Montreal Cognitive Assessment (MoCA).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 20, 2013
Actual (reported)March 22, 2013
Actual (reported)July 2014
Date type not reportedThis date has not been verified as actual or estimated.
June 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
improvement or no-worsening in MoCA score assessed at baseline and 2 year follow-up
The primary efficacy endpoint of this study will be the objective response rate (ORR); objective response being defined as improvement or no-worsening in MoCA score assessed at baseline and 2 year follow-up.
2 years
Correlation between MoCA score and physical activity, social support, anxiety and depression
2 years
Detail study information will be provided to the patients and written informed consent will be obtained from the each patient or family member before enrolling in the study. Consenting patients will be evaluated and the appropriate treatment strategy for managing arrhythmia will be independently determined by the physicians at the participating centers. Patients undergoing catheter ablation for AF will be included in the study group and those determined to stay on AAD will form the control group.
Texas Cardiac Arrhythmia Institute, St. david's Medical Center
Austin, Texas, 78705, United States
Mohanty S, Mohanty P, Trivedi C, Assadourian J, Mayedo AQ, MacDonald B, Della Rocca DG, Gianni C, Horton R, Al-Ahmad A, Bassiouny M, Burkhardt JD, Di Biase L, Gurol ME, Natale A. Impact of Oral Anticoagulation Therapy Versus Left Atrial Appendage Occlusion on Cognitive Function and Quality of Life in Patients With Atrial Fibrillation. J Am Heart Assoc. 2021 May 4;10(9):e019664. doi: 10.1161/JAHA.120.019664. Epub 2021 Apr 19.
Andrea Natale, MD
TCAI
Mitra Mohanty, MD
TCAI
First Submitted
March 20, 2013
First Posted
March 22, 2013
Study Start
July 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2020
Estimated (date passed)Impact of Anxiety on Cardiac Substrate Modification in Women With Atrial Fibrillation Undergoing Catheter Ablation
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 9, 2019
Record last verified: 2019-09
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Source: ClinicalTrials.gov.
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