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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: Completed study of Atrial Fibrillation, sponsored by University of Utah.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The percentage of pre-ablation fibrosis in atrial fibrillation patients can significantly impact the incidence of recurrences post-ablation.

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
University of Utah

818 total trials

What the finished NCT01150214 record still lists

NCT01150214 is an observational study that tracks outcomes without assigning an intervention. The registered 339 participants enrollment target is mid-sized for trials with a published cap, below the 2,995-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (89% lower).

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 lists 15 locations in 8 states (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.

Learn More About Clinical Trials

Similar trials for Atrial Fibrillation

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01150214's enrollment target sits among peer trials

339 78th of 202 higher than 125 of 202 other Atrial Fibrillation trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Atrial Fibrillation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01150214, the US trial registry maintained by the National Library of Medicine. NCT01150214 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.