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| ID | Type | Description | Link |
|---|---|---|---|
| 1R41HL127907-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMR Feasibility | Other | In this feasibility study, all ten patients will undergo EMR mapping which will be used to guide ablation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Real-time Electrogram Morphology Recurrence (EMR) Mapping Feasibility | As measured by number of patients where real-time EMR mapping is completed. | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Ablation Acute Effects | ablation based on EMR map as measured by number of participants that terminate atrial fibrillation. | 2 hours |
| Number of Participants With Treatment Emergent Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raul Mitrani, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | EMR Feasibility | In this feasibility study, all ten patients will undergo EMR mapping which will be used to guide ablation. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | EMR Feasibility | In this feasibility study, all ten patients will undergo EMR mapping which will be used to guide ablation. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Real-time Electrogram Morphology Recurrence (EMR) Mapping Feasibility | As measured by number of patients where real-time EMR mapping is completed. | Posted | Count of Participants | Participants | 2 hours |
|
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EMR Feasibility | In this feasibility study, all ten patients will undergo EMR mapping which will be used to guide ablation. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post ablation procedure -Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain from blood pressure cuff | Injury, poisoning and procedural complications | Non-systematic Assessment | Pain from blood pressure cuff in the left upper extremity during procedure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Jeffrey Goldberger | University of Miami | 305-243-4356 | j-goldberger@miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 19, 2019 | Jun 13, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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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
| 30 days |
| Ablation Acute Effects | ablation based on EMR map as measured by number of participants that slow atrial fibrillation cycle length by at least 15%. | 2 hours |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
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| Secondary | Ablation Acute Effects | ablation based on EMR map as measured by number of participants that terminate atrial fibrillation. | Posted | Count of Participants | Participants | 2 hours |
|
|
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| Secondary | 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 | Posted | Count of Participants | Participants | 30 days |
|
|
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| Secondary | Ablation Acute Effects | ablation based on EMR map as measured by number of participants that slow atrial fibrillation cycle length by at least 15%. | Posted | Count of Participants | Participants | 2 hours |
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|
| 0 |
| 10 |
| 1 |
| 10 |
| 2 |
| 10 |
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| Exacerbation of congestive heart failure | Cardiac disorders | Non-systematic Assessment |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |