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Efficacy of Delayed Enhancement MRI-Guided Ablation vs Conventional Catheter Ablation of Atrial Fibrillation (DECAAFII)

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ClinicalTrials.gov Identifier: NCT02529319
Recruitment Status : Recruiting
First Posted : August 20, 2015
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Nassir F. Marrouche, MD, University of Utah

Brief Summary:

This proposal is aiming at modifying and improving persistent AF management guidelines by evaluating targeting DE-MRI detected atrial fibrosis during AF ablation and its related effect on procedural outcome.

OBJECTIVES:

Primary Objective: To examine the efficacy of targeting atrial fibrosis tissue during an ablation procedure in treating persistent AF. Results from the DECAAF study show that one of the most important predictors of ablation outcome was the degree of ablation of the fibrotic tissue; the more fibrotic tissue that was overlapped with scar during ablation, the better the outcome. These results were the impetus for the primary outcome of DECAAF II. Patients will be randomized to receive conventional pulmonary vein isolation (PVI) ablation or PVI + fibrosis-guided ablation. The investigators will follow patients longitudinally to assess the primary outcome identified as recurrence of persistent atrial arrhythmias (AA) (atrial fibrillation, atrial flutter or atrial tachycardia as defined by recent guidelines [2]). The investigators hypothesize that patients receiving fibrosis-guided ablation in addition to conventional PVI ablation will have fewer AA recurrences than those who receive PVI ablation alone.

The investigators will also examine the efficacy of the fibrosis-guided ablation intervention on a number of secondary or exploratory outcomes including the individual components of the primary outcome (atrial fibrillation, atrial flutter and atrial tachycardia), symptomatic atrial arrhythmia, AF cycle length/regularity/termination, cardiovascular (CV)-related hospitalization, CV-related mortality, quality of life measurements (University of Toronto Atrial Fibrillation Severity Scale (AFSS), and AF burden.

The safety of the two interventions will be evaluated by evaluating peri-procedural complications including stroke, peripheral vascular stenosis, bleeding, esophageal injury, cardiac perforation, heart failure, and death.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Fibrosis Procedure: MRI-Guided Ablation Procedure: Conventional Ablation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy of Delayed Enhancement MRI-Guided Ablation vs Conventional Catheter Ablation of Atrial Fibrillation: The DECAAF II Study
Study Start Date : July 2016
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MRI-Guided Ablation

Surgery

Patients will undergo catheter ablation using DE-MRI as a guide for fibrosis imaging.

Procedure: MRI-Guided Ablation
Catheter ablation of AF will be guided by a DE-MRI of the patient's heart prior to the procedure.

Active Comparator: Conventional Ablation

Surgery

Patients will undergo conventional catheter ablation as described by the HRS guidelines.

Procedure: Conventional Ablation
Catheter ablation of AF using pulmonary vein isolation (PVI) will be performed using the HRS guidelines.




Primary Outcome Measures :
  1. AF Recurrence [ Time Frame: 18 months ]
    recurrence of 30 seconds of any atrial arrythmia as evidenced by a 45 second ECG strip.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients with persistent AF undergoing first AF ablation as per recent HRS consensus document. Persistent AF is defined by 7 days or more in AF as evidenced by either 1) rhythm strip or 2) written documentation.
  2. Must have some proportion of atrial fibrosis (not limited to advanced stage fibrosis)
  3. Able to understand and willing to sign the Informed Consent Form
  4. Age ≥ 18 years

Exclusion Criteria:

  1. Contraindication for DE-MRI with a full dose of Gadolinium-based contrast agent
  2. Previous left atrial ablation or surgical procedure
  3. Women currently pregnant
  4. Mental or physical inability to take part in the study
  5. Uncontrolled hypertension
  6. Inability to be placed in MRI due to body mass

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02529319


Contacts
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Contact: Christina Pacchia 8015873889 christina.pacchia@hsc.utah.edu

Locations
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United States, Utah
CARMA Center, University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Principal Investigator: Nassir F Marrouce, MD, FHRS         
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Nassir Marrouche, MD, FHRS Associate Professor

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Responsible Party: Nassir F. Marrouche, MD, Associate PRofessor, University of Utah
ClinicalTrials.gov Identifier: NCT02529319     History of Changes
Other Study ID Numbers: IRB_00076945
First Posted: August 20, 2015    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019

Keywords provided by Nassir F. Marrouche, MD, University of Utah:
atrial fibrillation
ablation

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes