Mapping Electrogram Morphology Recurrence for Atrial Fibrillation Ablation
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|ClinicalTrials.gov Identifier: NCT03082963|
Recruitment Status : Completed
First Posted : March 17, 2017
Last Update Posted : November 1, 2022
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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)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mapping Electrogram Morphology Recurrence for Atrial Fibrillation Ablation|
|Actual Study Start Date :||April 4, 2017|
|Actual Primary Completion Date :||June 18, 2022|
|Actual Study Completion Date :||June 18, 2022|
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.
- Real-time electrogram morphology recurrence mapping feasibility [ Time Frame: 2 hours ]Obtain multisite MRP map in the right and left atrium
- 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
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|Ages Eligible for Study:||21 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Male and female at least 21 years of age
- persistent Afib with one prior failed ablation for persistent or long standing persistent Afib
- 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.
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
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Raul Mitrani, MD||University of Miami|
|Responsible Party:||Jeffrey Goldberger, Chief, Cardiovascular Division, University of Miami|
|Other Study ID Numbers:||
1R41HL127907-01A1 ( U.S. NIH Grant/Contract )
|First Posted:||March 17, 2017 Key Record Dates|
|Last Update Posted:||November 1, 2022|
|Last Verified:||October 2022|
|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|