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NCT01150214 · ClinicalTrials.gov registry record

DECAAF: Delayed-Enhancement MRI (DE-MRI) Determinant of Successful Radiofrequency Catheter Ablation of Atrial Fibrillation

A clinical trial of Atrial Fibrillation, sponsored by University of Utah.

Completed
Registry status
339
Enrollment target
15
Study locations

NCT01150214 is a study of Atrial Fibrillation that has completed, run by University of Utah. The registered enrollment target is 339 participants, below the 2,995-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (89% lower). The trial reports 15 study locations across 8 states.

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The verdict

NCT01150214, a study of Atrial Fibrillation, has completed, sponsored by University of Utah.

COMPLETED
Registry status
339 participants
Enrollment target
15
Study locations

Study Summary

This is a multi-center, observational, 1-year prospective cohort study (1 year follow-up, at 3, 6 and 12 month) with approximately 675 participants. We will conduct a thorough outcomes assessment utilizing data from Magnetic Resonance Imaging (MRI) scans, as well as pre-procedure and follow-up data. Scans will be blinded to location of participating site. MRI scans will be sequenced and analyzed as they arrive from the database. Imaging Protocol: All patients will undergo a Delayed-Enhancement MRI (DE-MRI) within 30 days prior to the atrial fibrillation (AF) ablation procedure. The purpose of the initial MRI is to quantify the degree of atrial structural remodeling or fibrosis pre-ablation. Following ablation, DE-MRI will be obtained at 3, 6, and 12 months follow-up to detect and quantify ablation-related scar formation. Clinical Follow-up: The institution where the ablation was performed will continue post-procedural care following standard of care procedures. Atrial arrhythmia recurrences will be catalogued up to one year post-ablation and predictors of recurrences of AF will be determined by statistical analysis. The specific mechanism and electrophysiological characteristics of atrial arrhythmia recurrence will also be analyzed. Our hypotheses are (1) DE-MRI will reproducibly stage the progression left atrium fibrosis in AF; (2) DE-MRI will reproducibly aid in quantifying and identifying the distribution of catheter ablation-related scarring in the left atrium; and (3) the stage of left atrium fibrosis pre-ablation and the amount and location of scarring will predict success of catheter ablation therapy for AF.

Conditions Studied

Atrial Fibrillation

Interventions

  • PROCEDURE DE-MRI

Study Locations (15)

Other

  • Universitair Ziekenhuis Ghent - Ghent
  • Hôpital Cardiologique du Haut-Lévêque/Bordeaux - Bordeaux
  • Kerckhoff Klinik - Bad Nauheim
  • Coburg Klinik - Coburg
  • Institut für Diagnostische und Interventionelle Radiologie - koln - Cologne
  • Asklepios Klinik St. Georg - Hamburg
  • Universitatsklinikum Leipzig - Leipzig
  • St Antonius Ziekenhuis Hospital - Nieuwegein

Florida

  • Florida Heart Rhythm Institute - Tampa

Illinois

  • Loyola University Medical Center - Chicago

Ohio

  • Ohio State University Medical Center - Columbus

Pennsylvania

  • University of Pennsylvania Hospital - Philadelphia

Tennessee

  • Sarah Cannon Research Institute (Centennial) - Nashville

South Australia

  • Royal Adelaide Hospital - Norwood

Catalonia

  • Hospital Clinic de Barcelona - Barcelona

Trial Details

FieldValue
Enrollment Target 339 participants
Start Date 2010-07
Est. Completion 2012-09

Sponsor

University of Utah

818 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01150214

The ClinicalTrials.gov registry entry for NCT01150214 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 339 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,995-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (89% lower). The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Atrial Fibrillation appearing as the primary indexed condition, and to 1 intervention - of which DE-MRI is the first listed.

NCT01150214 reports 15 study locations spanning 8 distinct geographic areas - top geographies include Other, Florida, Illinois.

Frequently Asked Questions

What is clinical trial NCT01150214 about?

NCT01150214 is a clinical study titled "DECAAF: Delayed-Enhancement MRI (DE-MRI) Determinant of Successful Radiofrequency Catheter Ablation of Atrial Fibrillation". This is a multi-center, observational, 1-year prospective cohort study (1 year follow-up, at 3, 6 and 12 month) with approximately 675 participants. We will conduct a thorough outcomes assessment utilizing data from Magnetic Resonance Imaging (MRI) scans, as well as pre-procedure and follow-up data....

What is the current status of trial NCT01150214?

This trial is currently completed. The enrollment target is 339 participants. The study started on 2010-07. Estimated completion is 2012-09.

What conditions does trial NCT01150214 study?

This clinical trial studies the following conditions: Atrial Fibrillation.

What interventions are being tested in trial NCT01150214?

The interventions under investigation include: DE-MRI (PROCEDURE).

Who is sponsoring clinical trial NCT01150214?

This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01150214 being conducted?

This trial has 15 study locations across Florida, Illinois, Ohio, Pennsylvania, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.