Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of California | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The 64 pole basket catheter used for the mapping procedure will be defined "atypical" sites which sustain atrial fibrillation. The ablation through the driver will lead to more rapid ablation of the atrial fibrillation.
Atrial fibrillation (AF) is a common abnormal and rapid heart rhythm characterized by erratic electrical activity of the upper chambers of the heart. This cardiac arrhythmia may lead to stroke, heart failure, low blood pressure, chest pain, and increased mortality rate. Treatment may include medication to stop the rhythm abnormality, blood thinners, and/or ablation. Ablation involves application of heat or freezing to the area sustaining the rhythm abnormality. This requires tubes (catheters)to be placed in the heart. Human atrial fibrillation may be sustained by localized drivers (rapid and/or organized sites of atrial electrical activation). By mapping/recording the patient's specific atrial anatomy and atrial electrical activity with the 64-pole basket catheter, we may add to the knowledge base of these driver locations. We may also add to the knowledge about where best to ablate to terminate the arrhythmia. Typical anatomic
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 64 pole basket catheter | Other | all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 64 pole basket catheter | Procedure | The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Drivers in Right Atrial | To determine where atypical areas of drivers might be. | 30 min |
| Time to Ablation of All Sources | total time taken to ablate all sources of rotors/focal sources in driver locations | 30 minutes |
| Percentage of Patients With Greater Than One Right Atrial Source of Rotor/Focal Sources | percentage of patients | 30 minutes |
| Average Number of Rotors/Focal Drivers in Diverse Locations | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Successful Use of 64 Pole Basket Catheter at Non-University of California San Diego Electrophysiology Labs | To determine if the 64 pole basket catheter will be successfully used to gather information on Atrial Fibrillation drivers. | 30 min |
| Mean Time to Recurrence of Atrial Fibrillation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kenneth A Ellenbogen, MD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23130890 | Result | Shivkumar K, Ellenbogen KA, Hummel JD, Miller JM, Steinberg JS. Acute termination of human atrial fibrillation by identification and catheter ablation of localized rotors and sources: first multicenter experience of focal impulse and rotor modulation (FIRM) ablation. J Cardiovasc Electrophysiol. 2012 Dec;23(12):1277-85. doi: 10.1111/jce.12000. Epub 2012 Nov 6. | |
| 23993247 |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 64 Pole Basket Catheter | all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation 64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
48 patients with persistent AF, 7=longstanding AF, 23 paroxysmal AF
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 64 Pole Basket Catheter | all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation 64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy. |
| 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 | Percentage of Drivers in Right Atrial | To determine where atypical areas of drivers might be. | Posted | Number | percentage of rotor sources | 30 min |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 64 Pole Basket Catheter | all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation 64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenneth Ellenbogen | Virginia CU | 804-828-7565 | kellenbogen@mcvh-vcu.edu |
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
mean time to recurrence of atrial fibrillation |
| 1 year |
| Single-procedure Freedom From Atrial Fibrillation | percentage of patients without prior ablation | one year |
| Percentage of All Patients Who Underwent Ablation of Rotor/Focal Sources of Atrial Fibrillation | percentage of all patients who had ablation perfornmed | 1 year |
| Baykaner T, Clopton P, Lalani GG, Schricker AA, Krummen DE, Narayan SM; CONFIRM Investigators. Targeted ablation at stable atrial fibrillation sources improves success over conventional ablation in high-risk patients: a substudy of the CONFIRM Trial. Can J Cardiol. 2013 Oct;29(10):1218-26. doi: 10.1016/j.cjca.2013.07.672. Epub 2013 Aug 30. |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Atrial Fibrillation | Measure title Atrial Fibrillation | Number | participants |
|
|
| Primary | Time to Ablation of All Sources | total time taken to ablate all sources of rotors/focal sources in driver locations | patients participating undergo mapping using the 64 pole basket catheter | Posted | Mean | Standard Deviation | minutes | 30 minutes |
|
|
|
| Primary | Percentage of Patients With Greater Than One Right Atrial Source of Rotor/Focal Sources | percentage of patients | Posted | Number | percentage of patients | 30 minutes |
|
|
|
| Primary | Average Number of Rotors/Focal Drivers in Diverse Locations | Posted | Mean | Standard Deviation | rotor/focal drivers | 30 minutes |
|
|
|
| Secondary | Number of Participants With Successful Use of 64 Pole Basket Catheter at Non-University of California San Diego Electrophysiology Labs | To determine if the 64 pole basket catheter will be successfully used to gather information on Atrial Fibrillation drivers. | Posted | Number | participants | 30 min |
|
|
|
| Secondary | Mean Time to Recurrence of Atrial Fibrillation | mean time to recurrence of atrial fibrillation | patients participating undergo mapping using the 64 pole basket catheter | Posted | Mean | Full Range | days | 1 year |
|
|
|
| Secondary | Single-procedure Freedom From Atrial Fibrillation | percentage of patients without prior ablation | percentage of patients who underwent mapping with 64 pole basket catheter | Posted | Number | percentage of patients with no prior abl | one year |
|
|
|
| Secondary | Percentage of All Patients Who Underwent Ablation of Rotor/Focal Sources of Atrial Fibrillation | percentage of all patients who had ablation perfornmed | all patients participating undergo mapping using the 64 pole basket catheter | Posted | Number | percentage of all patients undergoing ab | 1 year |
|
|
|
| 0 |
| 78 |
| 0 |
| 78 |
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |