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Mapping Electrogram Morphology Recurrence for Atrial Fibrillation Ablation

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ClinicalTrials.gov Identifier: NCT03082963
Recruitment Status : Recruiting
First Posted : March 17, 2017
Last Update Posted : February 7, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jeffrey Goldberger, University of Miami

Brief Summary:

The overall goal of this project is to test the feasibility of performing real-time electrogram morphology recurrence (EMR) mapping in patients with persistent atrial fibrillation (AF) to locate areas of high electrogram morphology recurrence rate. The Investigator believe that the EMR mapping can be integrated into cardiac mapping and used to identify potential sites for ablation. Furthermore, this study could help demonstrate the efficacy of this technology's ability to terminate or slow AF.

The Investigator will test this technology on ten subjects undergoing a second ablation procedure. The Investigator will map the AF utilizing the EMR to indicate locations of stable activity and ablate the area. The Investigator believes that the study could produce acute AF termination or AF cycle length slowing. In addition to testing the real-time electrogram morphology recurrence mapping, the study would also like to determine the acute effects of radiofrequency ablation of areas of high recurrence rates and determine long term freedom from AF following ablation of areas of high recurrence rates.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: Electrogram Morphology Mapping (EMR) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mapping Electrogram Morphology Recurrence for Atrial Fibrillation Ablation
Actual Study Start Date : April 4, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
EMR Feasibility
In this feasibility study, all ten patients will undergo EMR mapping which will be used to guide ablation.
Device: Electrogram Morphology Mapping (EMR)
Fifteen second AF recordings will be made using a multipolar electrode catheter to map the entire right atrium & then the left atrium.




Primary Outcome Measures :
  1. Real-time electrogram morphology recurrence mapping feasibility [ Time Frame: 2 hours ]
    Obtain multisite MRP map in the right and left atrium


Secondary Outcome Measures :
  1. Ablation Acute Effects [ Time Frame: 2 hours ]
    ablation based on MRP map will either terminate atrial fibrillation or slow atrial fibrillation cycle length by at least 15%

  2. 30-day post ablation treatment emergent adverse events [ Time Frame: 30 days ]
    30 days post ablation procedure safety endpoints will be collected categorizing the type of adverse event, severity, and whether the AE/SAE is related to the mapping



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female at least 21 years of age
  • persistent Afib with one prior failed ablation for persistent or long standing persistent Afib

Exclusion Criteria:

  • Inability to sign consent
  • Patients with a life expectancy less than one (1) year
  • Patients with chronic kidney disease with sufficiently low GFR that precludes either CT angiogram of the heart or contrast MRI study
  • Pregnant women and women that are breast feeding
  • Patients with multiple (2 or more) prior failed ablations
  • Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.

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): NCT03082963


Contacts
Contact: Raul Mitrani, MD 305-243-5070 rmitrani@med.miami.edu

Locations
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Raul Mitrani, MD    305-243-5070    rmitrani@med.miami.edu   
Principal Investigator: Raul Mitrani, MD         
Sponsors and Collaborators
Jeffrey Goldberger
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Raul Mitrani, MD University of Miami

Responsible Party: Jeffrey Goldberger, Chief, Cardiovascular Division, University of Miami
ClinicalTrials.gov Identifier: NCT03082963     History of Changes
Other Study ID Numbers: 20150757
1R41HL127907-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 17, 2017    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Jeffrey Goldberger, University of Miami:
atrial fibrillation
ablation

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