Atrial Fibrillation, Persistent Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation, Persistent Atrial Fibrillation, AFIB, Arrhythmia
Brief summary
This is a prospective, multi-center, non-randomized, un-blinded, observational trial.
Detailed description
This prospective, multicenter observational study will examine the ability of ECGi mapping to 1. Effect of Ibutilide on the number and size of the driver domains 2. Effect of ablation of Ibutilide-organized driver domains 3. Effect of PV isolation on driver domains The researchers hypothesize that this approach will lead to successful arrhythmia control .
Interventions
DEVICECardioInsight ECGI Mapping System
The CardioInsight mapping system is a noninvasive, single beat cardiac arrhythmia mapping system that provides 3D electroanatomic maps of the heart.
PROCEDUREAF ablation
Empiric ablation (CFAE or linear ablation) is not permitted
DRUGIbutilide
Progressive doses of Ibutilide administered (0.25mg, then 0.25mg, then 0.5mg)
Sponsors
Medtronic
Vivek Reddy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. * Planned to undergo first catheter ablation procedure ( prior atrial flutter typical is allowed) * 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
* They have baseline prolonged QT or renal failure precluding safe used of ibutilide * Rheumatic heart disease, * Current intra-cardiac thrombus, * History of MI or CABG within 6 weeks; * Class IV HF, * Unable to sign consent * Projected lifespan of \< 1 year * Women known to be pregnant or to have positive beta-HCG. * Participation in another study that would interfere with this study. * Unstable Angina * Recent cerebral ischemic events * Contraindication to anticoagulation * Prior history of polymorphic ventricular tachycardia or torsades de pointes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who no Longer Has Recurrent At/AF | at 12 months | Freedom from recurrent At/AF |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Drivers | Baseline | Number of drivers identified |
| Size of Drivers | Baseline | Size of drivers ablated |
| Percent Change of Driver Regions | Baseline and 1 year | Percent change of driver regions after ibutilide |
| AF Termination Rate | post ablation inducibility of AF after 5 minutes of burst pacing | AF termination rate is defined as AF termination to AT/SR (Atrial Tachycardia/Sinus Rhythm) |
| Total Procedure Time | within 24 hours after the procedure is completed the time is calculated | Total duration of RF ablation/fluoroscopy time/exposure procedure time |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients With Atrial Fibrillation (AF) Patients with AF and planned to undergo first catheter procedure | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Patients With Atrial Fibrillation (AF) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Number of Participants Who no Longer Has Recurrent At/AF
Freedom from recurrent At/AF
Time frame: at 12 months
Population: Participant screen failed
Secondary
AF Termination Rate
AF termination rate is defined as AF termination to AT/SR (Atrial Tachycardia/Sinus Rhythm)
Time frame: post ablation inducibility of AF after 5 minutes of burst pacing
Population: Participant screen failed
Secondary
Number of Drivers
Number of drivers identified
Time frame: Baseline
Population: Participant screen failed
Secondary
Percent Change of Driver Regions
Percent change of driver regions after ibutilide
Time frame: Baseline and 1 year
Population: Participant screen failed
Secondary
Size of Drivers
Size of drivers ablated
Time frame: Baseline
Population: Participant screen failed
Secondary
Total Procedure Time
Total duration of RF ablation/fluoroscopy time/exposure procedure time
Time frame: within 24 hours after the procedure is completed the time is calculated
Population: Participant screen failed