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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02997254
Other study ID # COMPARE_AF
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2016
Est. completion date November 30, 2026

Study information

Verified date November 2023
Source Stanford University
Contact Sanjiv M Narayan, MD, PhD
Phone (650) 723-9363
Email sanjiv1@stanford.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a cohort study to evaluate algorithms for mapping atrial fibrillation by mapping atrial structure and mapping electrical activity to detect focal and rotational activity.


Description:

In this study, the investigators will compare mapping approaches for atrial fibrillation ablation. First, investigators will compare approaches to map atrial structure from collected computed tomography (CT) scans or magnetic resonance imaging (MRI) scans acquired routinely in patients undergoing ablation for atrial fibrillation. Imaging will be acquired from a variety of clinically approved Second, investigators will compare approaches to analyze electrograms collected routinely at clinical electrophysiology study (EPS) in patients undergoing ablation for atrial fibrillation. Electrograms will be recorded from a variety of clinically approved catheters under standard of care conditions, and will be analyzed to better understand the mechanisms for atrial fibrillation and its relationship to outcomes. The investigators anticipate analyzing data from 200 patients through December 2017.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date November 30, 2026
Est. primary completion date November 30, 2025
Accepts healthy volunteers No
Gender All
Age group 21 Years to 90 Years
Eligibility Inclusion Criteria: - aged 21-80 yrs who underwent electrophysiology study for ablation of Atrial Fibrillation Exclusion Criteria: - Poor data quality of recordings of AF

Study Design


Locations

Country Name City State
United States Stanford University Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (7)

Benharash P, Buch E, Frank P, Share M, Tung R, Shivkumar K, Mandapati R. Quantitative analysis of localized sources identified by focal impulse and rotor modulation mapping in atrial fibrillation. Circ Arrhythm Electrophysiol. 2015 Jun;8(3):554-61. doi: 10.1161/CIRCEP.115.002721. Epub 2015 Apr 14. — View Citation

Haissaguerre M, Hocini M, Denis A, Shah AJ, Komatsu Y, Yamashita S, Daly M, Amraoui S, Zellerhoff S, Picat MQ, Quotb A, Jesel L, Lim H, Ploux S, Bordachar P, Attuel G, Meillet V, Ritter P, Derval N, Sacher F, Bernus O, Cochet H, Jais P, Dubois R. Driver domains in persistent atrial fibrillation. Circulation. 2014 Aug 12;130(7):530-8. doi: 10.1161/CIRCULATIONAHA.113.005421. Epub 2014 Jul 15. — View Citation

Jalife J, Filgueiras Rama D, Berenfeld O. Letter by Jalife et al Regarding Article, "Quantitative Analysis of Localized Sources Identified by Focal Impulse and Rotor Modulation Mapping in Atrial Fibrillation". Circ Arrhythm Electrophysiol. 2015 Oct;8(5):1296-8. doi: 10.1161/CIRCEP.115.003324. No abstract available. — View Citation

Kuklik P, Zeemering S, Maesen B, Maessen J, Crijns HJ, Verheule S, Ganesan AN, Schotten U. Reconstruction of instantaneous phase of unipolar atrial contact electrogram using a concept of sinusoidal recomposition and Hilbert transform. IEEE Trans Biomed Eng. 2015 Jan;62(1):296-302. doi: 10.1109/TBME.2014.2350029. Epub 2014 Aug 20. — View Citation

Kuklik P, Zeemering S, van Hunnik A, Maesen B, Pison L, Lau DH, Maessen J, Podziemski P, Meyer C, Schaffer B, Crijns H, Willems S, Schotten U. Identification of Rotors during Human Atrial Fibrillation Using Contact Mapping and Phase Singularity Detection: Technical Considerations. IEEE Trans Biomed Eng. 2017 Feb;64(2):310-318. doi: 10.1109/TBME.2016.2554660. Epub 2016 Apr 15. — View Citation

Narayan SM, Krummen DE, Enyeart MW, Rappel WJ. Computational mapping identifies localized mechanisms for ablation of atrial fibrillation. PLoS One. 2012;7(9):e46034. doi: 10.1371/journal.pone.0046034. Epub 2012 Sep 26. — View Citation

Narayan SM, Krummen DE, Shivkumar K, Clopton P, Rappel WJ, Miller JM. Treatment of atrial fibrillation by the ablation of localized sources: CONFIRM (Conventional Ablation for Atrial Fibrillation With or Without Focal Impulse and Rotor Modulation) trial. J Am Coll Cardiol. 2012 Aug 14;60(7):628-36. doi: 10.1016/j.jacc.2012.05.022. Epub 2012 Jul 18. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic Accuracy Comparing mapping systems to diagnose sites of importance in Atrial Fibrillation At the time of procedure
Primary Diagnostic Accuracy Comparing algorithms to segment atrial structures from computed tomography or Magnetic resonance images. At time of procedure.
Secondary Analysis Time Comparing time required to segment atrial structures from computed tomography or magnetic resonance images. At time of procedure.
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