Mapping Electrogram Morphology Recurrence for Atrial Fibrillation Ablation
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electrogram Morphology Mapping (EMR)
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, ablation
Eligibility 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.
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
EMR Feasibility
Arm Description
In this feasibility study, all ten patients will undergo EMR mapping which will be used to guide ablation.
Outcomes
Primary Outcome Measures
Real-time Electrogram Morphology Recurrence (EMR) Mapping Feasibility
As measured by number of patients where real-time EMR mapping is completed.
Secondary Outcome Measures
Ablation Acute Effects
ablation based on EMR map as measured by number of participants that terminate atrial fibrillation.
Number of Participants With Treatment Emergent Adverse Events
Number of participants with treatment emergent adverse events will be measured by the type of adverse event, severity, and whether the AE/SAE is related to the mapping
Ablation Acute Effects
ablation based on EMR map as measured by number of participants that slow atrial fibrillation cycle length by at least 15%.
Full Information
NCT ID
NCT03082963
First Posted
February 27, 2017
Last Updated
July 17, 2023
Sponsor
Jeffrey Goldberger
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT03082963
Brief Title
Mapping Electrogram Morphology Recurrence for Atrial Fibrillation Ablation
Official Title
Mapping Electrogram Morphology Recurrence for Atrial Fibrillation Ablation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 4, 2017 (Actual)
Primary Completion Date
June 18, 2022 (Actual)
Study Completion Date
June 18, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jeffrey Goldberger
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EMR Feasibility
Arm Type
Other
Arm Description
In this feasibility study, all ten patients will undergo EMR mapping which will be used to guide ablation.
Intervention Type
Device
Intervention Name(s)
Electrogram Morphology Mapping (EMR)
Intervention Description
Fifteen second AF recordings will be made using a multipolar electrode catheter to map the entire right atrium & then the left atrium.
Primary Outcome Measure Information:
Title
Real-time Electrogram Morphology Recurrence (EMR) Mapping Feasibility
Description
As measured by number of patients where real-time EMR mapping is completed.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Ablation Acute Effects
Description
ablation based on EMR map as measured by number of participants that terminate atrial fibrillation.
Time Frame
2 hours
Title
Number of Participants With Treatment Emergent Adverse Events
Description
Number of participants with treatment emergent adverse events will be measured by the type of adverse event, severity, and whether the AE/SAE is related to the mapping
Time Frame
30 days
Title
Ablation Acute Effects
Description
ablation based on EMR map as measured by number of participants that slow atrial fibrillation cycle length by at least 15%.
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raul Mitrani, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mapping Electrogram Morphology Recurrence for Atrial Fibrillation Ablation
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