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1 patient enrolled (consented) but screen failed. Study stopped as unable to enroll.
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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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This is a prospective, multi-center, non-randomized, un-blinded, observational trial.
This prospective, multicenter observational study will examine the ability of ECGi mapping to
The researchers hypothesize that this approach will lead to successful arrhythmia control .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with AF | Experimental | Patients with AF and planned to undergo first catheter procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CardioInsight ECGI Mapping System | Device | The CardioInsight mapping system is a noninvasive, single beat cardiac arrhythmia mapping system that provides 3D electroanatomic maps of the heart. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who no Longer Has Recurrent At/AF | Freedom from recurrent At/AF | at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Drivers | Number of drivers identified | Baseline |
| Size of Drivers | Size of drivers ablated | Baseline |
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Inclusion Criteria:
≥ 18 years of age.
° Symptomatic persistent AF refractory or intolerant to at least 1 class I or III antiarrhythmic medication Persistent AF - defined as Persistent: AF that is sustained > 7 days. Episodes of AF which are terminated by electrical or pharmacologic cardioversion after ≥ 48 hours of AF, but prior to 7 days, should also be classified as persistent AF episodes.
Ability to understand the requirements of the study and sign the informed consent form.
Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements
Projected lifespan greater than 1 year
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacob Koruth, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Vivek Reddy, MD | Icahn School of Medicine at Mount Sinai | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With AF | Patients with AF and planned to undergo first catheter procedure CardioInsight ECGI Mapping System: The CardioInsight mapping system is a noninvasive, single beat cardiac arrhythmia mapping system that provides 3D electroanatomic maps of the heart. AF ablation: Empiric ablation (CFAE or linear ablation) is not permitted Ibutilide: Progressive doses of Ibutilide administered (0.25mg, then 0.25mg, then 0.5mg) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Atrial Fibrillation (AF) | Patients with AF and planned to undergo first catheter procedure |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants Who no Longer Has Recurrent At/AF | Freedom from recurrent At/AF | Participant screen failed | Posted | at 12 months |
|
|
1 year
Participant screen failed
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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 | Patients With Atrial Fibrillation (AF) | Patients with AF and planned to undergo first catheter procedure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Vivek Reddy | Icahn School of Medicine at Mount Sinai | (212) 241-7114 | vivek.reddy@mountsinai.org |
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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 | Apr 1, 2017 | Jan 17, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C067192 | ibutilide |
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|
| AF ablation | Procedure | Empiric ablation (CFAE or linear ablation) is not permitted |
|
|
| Ibutilide | Drug | Progressive doses of Ibutilide administered (0.25mg, then 0.25mg, then 0.5mg) |
|
| Percent Change of Driver Regions | Percent change of driver regions after ibutilide | Baseline and 1 year |
| AF Termination Rate | AF termination rate is defined as AF termination to AT/SR (Atrial Tachycardia/Sinus Rhythm) | post ablation inducibility of AF after 5 minutes of burst pacing |
| Total Procedure Time | Total duration of RF ablation/fluoroscopy time/exposure procedure time | within 24 hours after the procedure is completed the time is calculated |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Secondary | Number of Drivers | Number of drivers identified | Participant screen failed | Posted | Baseline |
|
|
| Secondary | Size of Drivers | Size of drivers ablated | Participant screen failed | Posted | Baseline |
|
|
| Secondary | Percent Change of Driver Regions | Percent change of driver regions after ibutilide | Participant screen failed | Posted | Baseline and 1 year |
|
|
| Secondary | AF Termination Rate | AF termination rate is defined as AF termination to AT/SR (Atrial Tachycardia/Sinus Rhythm) | Participant screen failed | Posted | post ablation inducibility of AF after 5 minutes of burst pacing |
|
|
| Secondary | Total Procedure Time | Total duration of RF ablation/fluoroscopy time/exposure procedure time | Participant screen failed | Posted | within 24 hours after the procedure is completed the time is calculated |
|
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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