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 : October 17, 2018
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)|
|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|
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
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
|Contact: Raul Mitrani, MDfirstname.lastname@example.org|
|United States, Florida|
|University of Miami||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Raul Mitrani, MD 305-243-5070 email@example.com|
|Principal Investigator: Raul Mitrani, MD|
|Principal Investigator:||Raul Mitrani, MD||University of Miami|