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Mapping Electrogram Morphology Recurrence for Atrial Fibrillation Ablation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03082963
Recruitment Status : Recruiting
First Posted : March 17, 2017
Last Update Posted : December 9, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jeffrey Goldberger, University of Miami

Tracking Information
First Submitted Date  ICMJE February 27, 2017
First Posted Date  ICMJE March 17, 2017
Last Update Posted Date December 9, 2019
Actual Study Start Date  ICMJE April 4, 2017
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2017)
Real-time electrogram morphology recurrence mapping feasibility [ Time Frame: 2 hours ]
Obtain multisite MRP map in the right and left atrium
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2017)
  • 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%
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mapping Electrogram Morphology Recurrence for Atrial Fibrillation Ablation
Official Title  ICMJE Mapping Electrogram Morphology Recurrence for Atrial Fibrillation Ablation
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE 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.
Study Arms  ICMJE EMR Feasibility
In this feasibility study, all ten patients will undergo EMR mapping which will be used to guide ablation.
Intervention: Device: Electrogram Morphology Mapping (EMR)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 12, 2017)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Raul Mitrani, MD 305-243-5070 rmitrani@med.miami.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03082963
Other Study ID Numbers  ICMJE 20150757
1R41HL127907-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jeffrey Goldberger, University of Miami
Study Sponsor  ICMJE Jeffrey Goldberger
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Raul Mitrani, MD University of Miami
PRS Account University of Miami
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP