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OpenTrials
Completed

NCT Number: NCT03082963

Mapping Electrogram Morphology Recurrence for Atrial Fibrillation Ablation

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Electrogram Morphology Mapping (EMR)

Device

Fifteen second AF recordings will be made using a multipolar electrode catheter to map the entire right atrium & then the left atrium.

Primary outcomes

  1. Real-time Electrogram Morphology Recurrence (EMR) Mapping Feasibility

    Time frame: 2 hours

    As measured by number of patients where real-time EMR mapping is completed.

Secondary outcomes

  1. Ablation Acute Effects

    Time frame: 2 hours

    ablation based on EMR map as measured by number of participants that terminate atrial fibrillation.

  2. Number of Participants With Treatment Emergent Adverse Events

    Time frame: 30 days

    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

  3. Ablation Acute Effects

    Time frame: 2 hours

    ablation based on EMR map as measured by number of participants that slow atrial fibrillation cycle length by at least 15%.

Sponsors and collaborators

Lead sponsor

Jeffrey Goldberger

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Mar 17, 2017
Registry last updated
Aug 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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