Atrial Fibrillation
Conditions
Keywords
atrial fibrillation, cardiac ablation
Brief summary
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.
Detailed description
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
Interventions
PROCEDURE64 pole basket catheter
The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy.
Sponsors
University of California
Virginia Commonwealth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients at VCU Medical Center who are 21 years or older undergoing EPS for ablation of persistent AF (non-rheumatic) whose AF episodes last equal to or greater than 7 days but terminate with DC cardioversion or anti-arrhythmic drugs and do not recur within 24 hours. * Per current standard of care, AF patients must have failed equal to or greater than 1 anti-arrhythmic drug to qualify for ablation.
Exclusion criteria
* Active coronary ischemic in the past year * Rheumatic valve disease, that leads to distinct AF and increases thromboembolic risk * Prior ablation or cardiac surgery, that alters atrial electophysiology * Left atrial clot or dense contrast on TEE, which would increase thromboembolic risk * Out of range serum electrolytes, including K outside 4.0-5.0 mmol/1 * Left atrial diameter greater than 60 mm, to exclude extreme structural remodeling and failure to maintain sinus rhythm * Thrombotic disease, venous filters, transient ischemic attack or cerebrovascular accident, to minimize additional risk * Pregnancy * Inability or unwillingness to provide informed consent * Unable to converse in English * Use of anti-arrhythmic drug less than 5 X half-life Prior ablation or cardiac surgery, that alters atrial electophysiology
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Number of Rotors/Focal Drivers in Diverse Locations | 30 minutes | — |
| Percentage of Drivers in Right Atrial | 30 min | To determine where atypical areas of drivers might be. |
| Time to Ablation of All Sources | 30 minutes | total time taken to ablate all sources of rotors/focal sources in driver locations |
| Percentage of Patients With Greater Than One Right Atrial Source of Rotor/Focal Sources | 30 minutes | percentage of patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Use of 64 Pole Basket Catheter at Non-University of California San Diego Electrophysiology Labs | 30 min | To determine if the 64 pole basket catheter will be successfully used to gather information on Atrial Fibrillation drivers. |
| Mean Time to Recurrence of Atrial Fibrillation | 1 year | mean time to recurrence of atrial fibrillation |
| Single-procedure Freedom From Atrial Fibrillation | one year | percentage of patients without prior ablation |
| Percentage of All Patients Who Underwent Ablation of Rotor/Focal Sources of Atrial Fibrillation | 1 year | percentage of all patients who had ablation perfornmed |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 78 |
| Total | 78 |
Baseline characteristics
| Characteristic | 64 Pole Basket Catheter |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 76 Participants |
| Age, Continuous | 61 years |
| Atrial Fibrillation longstanding persisitent atrial fibrillation | 7 participants |
| Atrial Fibrillation paroxysmal atrial fibrillation | 23 participants |
| Atrial Fibrillation persisitent atrial fibrillation | 48 participants |
| Region of Enrollment United States | 78 participants |
| Sex: Female, Male Female | NA Participants |
| Sex: Female, Male Male | NA Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 78 |
| serious Total, serious adverse events | 0 / 78 |
Outcome results
Primary
Average Number of Rotors/Focal Drivers in Diverse Locations
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 64 Pole Basket Catheter | Average Number of Rotors/Focal Drivers in Diverse Locations | 2.3 rotor/focal drivers | Standard Deviation 0.9 |
Primary
Percentage of Drivers in Right Atrial
To determine where atypical areas of drivers might be.
Time frame: 30 min
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 64 Pole Basket Catheter | Percentage of Drivers in Right Atrial | 25.3 percentage of rotor sources |
Primary
Percentage of Patients With Greater Than One Right Atrial Source of Rotor/Focal Sources
percentage of patients
Time frame: 30 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 64 Pole Basket Catheter | Percentage of Patients With Greater Than One Right Atrial Source of Rotor/Focal Sources | 50 percentage of patients |
Primary
Time to Ablation of All Sources
total time taken to ablate all sources of rotors/focal sources in driver locations
Time frame: 30 minutes
Population: patients participating undergo mapping using the 64 pole basket catheter
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 64 Pole Basket Catheter | Time to Ablation of All Sources | 16.6 minutes | Standard Deviation 11.7 |
Secondary
Mean Time to Recurrence of Atrial Fibrillation
mean time to recurrence of atrial fibrillation
Time frame: 1 year
Population: patients participating undergo mapping using the 64 pole basket catheter
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 64 Pole Basket Catheter | Mean Time to Recurrence of Atrial Fibrillation | 245 days |
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.
Time frame: 30 min
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 64 Pole Basket Catheter | Number of Participants With Successful Use of 64 Pole Basket Catheter at Non-University of California San Diego Electrophysiology Labs | 78 participants |
Secondary
Percentage of All Patients Who Underwent Ablation of Rotor/Focal Sources of Atrial Fibrillation
percentage of all patients who had ablation perfornmed
Time frame: 1 year
Population: all patients participating undergo mapping using the 64 pole basket catheter
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 64 Pole Basket Catheter | Percentage of All Patients Who Underwent Ablation of Rotor/Focal Sources of Atrial Fibrillation | 80.5 percentage of all patients undergoing ab |
Secondary
Single-procedure Freedom From Atrial Fibrillation
percentage of patients without prior ablation
Time frame: one year
Population: percentage of patients who underwent mapping with 64 pole basket catheter
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 64 Pole Basket Catheter | Single-procedure Freedom From Atrial Fibrillation | 87.5 percentage of patients with no prior abl |