Persistent Atrial Fibrillation
Conditions
Keywords
Persistent Atrial Fibrillation, mapping
Brief summary
This prospective, multicenter, observational study will examine the ability of real time electrogram processing mapping to identify driver domains to target for ablation in persistent AF patients.
Detailed description
ABSTRACT: Recent clinical trials have shown that targeting rotors and focal impulses (FIs) during atrial fibrillation (AF) ablation improves outcomes. This study evaluated whether a novel computational mapping algorithm (CMA) could identify FIs and rotors, and characterize rotors when incidental ablation resulted in rhythm changes. Three-dimensional (3D) left atrial electroanatomic maps were created from signals recorded from multipolar circular mapping catheters in 61 patients undergoing persistent AF ablation. Forty of 61acquired patient datasets were of adequate quality for analysis CMA, employing an AF pattern recognition algorithm, creating 3D panoramic AF maps identifying drivers of AF (FI and rotors) post procedure. Rotors were further classified as substrate (SBR) or non-substrate based (NSBR) on the basis of rotor stability, proximity to voltage transition zones and complex fractionated atrial electrograms (CFAEs). Incidentally ablated identified AF drivers, including SBRs and NSBRs, were evaluated for rhythm changes. A total of 172 drivers were identified in 40 patients (2.2 drivers/patient). Seventy percent were rotors (120/172) and 30% were FIs (52/172). Sixty-seven percent of rotors were classified as SBR vs 33% as NSBR. Incidental ablation of SBRs resulted in rhythm change 91% of the time versus only 24% of the time for NSBR (p\<0.0001).
Interventions
DEVICEComputational Mapping Algorithm
This software enables high resolution temporospatial mapping of atria for the identification of drivers of AF. CMA receives data from standard of care, commercially available 3D Mapping Systems (St. Jude Ensite System) and catheters and processes the data in a unique way. Electrogram and anatomy data are fed from the commercially available 3D Mapping System to an adjacent laptop computer, via an Ethernet connection, that is running CMA. CMA then processes the electrogram data and generates a map of where the potential AF driver domains are located and superimposes those potential AF driver domain targets onto the 3D geometry of the anatomy (provided by the 3D mapping system).
Sponsors
AFTx, Inc.
Vivek Reddy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 18 years of age. * Patients are considered eligible if they have symptomatic or drug-refractory AF and are planned to undergo a catheter ablation procedure for persistent AF (ether a first procedure or a redo procedure) * 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 long-standing persistent AF prior to the first procedure (defined as AF greater than one year's duration). * Rheumatic heart disease * Current intra-cardiac thrombus * History of MI or Coronary Artery Bypass Grafting (CABG) within 6 weeks * Unstable angina * CVA or TIA within 3 months * Contraindication to anticoagulation * Class IV HF * Unable to sign consent * Projected lifespan of \< 1 year * Women known to be pregnant or to have positive beta-HCG (Human Chorionic Gonadotropin). * Participation in another study that would interfere with this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Atrial Fibrillation Termination | Day 1 | Acute Procedural Outcomes as defined by termination of Atrial Fibrillation into normal sinus rhythm (NSR) or atrial tachycardia (AT) |
| Number of Participants Free From Recurrent AT/AF on no AAD | at 12 months | Number of Participants freedom from recurrent Atrial Tachycardia/Atrial Fibrillation with no use of Anti-Arrhythmic Drugs (AAD) |
| Number of Participants Free From Recurrent AT/AF With no or Some AAD | at 12 months | Number of Participants Free recurrent Atrial Tachycardia/Atrial Fibrillation with either some or no use of Anti-Arrhythmic Drugs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Exposure | Day 1 | Radiation exposure due to fluoroscopy during the AF ablation procedure |
| Duration of Procedure Time | Day 1 | Duration of RADAR procedure time |
| Rate of Post-ablation Inducibility of AF | Day 1 | Post-ablation inducibility of AF (\> 5 mins) with burst pacing |
| Number of Major Adverse Cardiac Events (MACE) | 12 months | — |
| Number of Serious Adverse Events | 12 months | — |
| Number of Procedure-related Adverse Events | up to 12 months | — |
| Duration of RF Ablation | Day 1 | Amount of radiofrequency ablation used for atrial fibrillation ablation |
| Duration of Fluoro Time | Day 1 | Duration of fluoroscopy used during the AF ablation procedure |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| De Novo Participants with 1st procedure | 38 |
| Re-Do Ablation Participants who need a re-do ablation procedure | 26 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Re-Do Ablation | Total | De Novo |
|---|---|---|---|
| Age, Continuous | 65.4 years STANDARD_DEVIATION 9.9 | 64.7 years STANDARD_DEVIATION 9.5 | 64.2 years STANDARD_DEVIATION 9.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 62 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 24 Participants | 60 Participants | 36 Participants |
| Sex: Female, Male Female | 5 Participants | 17 Participants | 12 Participants |
| Sex: Female, Male Male | 21 Participants | 47 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 26 |
| other Total, other adverse events | 8 / 38 | 3 / 26 |
| serious Total, serious adverse events | 10 / 38 | 5 / 26 |
Outcome results
Primary
Number of Participants Free From Recurrent AT/AF on no AAD
Number of Participants freedom from recurrent Atrial Tachycardia/Atrial Fibrillation with no use of Anti-Arrhythmic Drugs (AAD)
Time frame: at 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| De Novo | Number of Participants Free From Recurrent AT/AF on no AAD | 25 Participants |
| Re-Do Ablation | Number of Participants Free From Recurrent AT/AF on no AAD | 13 Participants |
Primary
Number of Participants Free From Recurrent AT/AF With no or Some AAD
Number of Participants Free recurrent Atrial Tachycardia/Atrial Fibrillation with either some or no use of Anti-Arrhythmic Drugs
Time frame: at 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| De Novo | Number of Participants Free From Recurrent AT/AF With no or Some AAD | 25 Participants |
| Re-Do Ablation | Number of Participants Free From Recurrent AT/AF With no or Some AAD | 17 Participants |
Primary
Number of Participants With Atrial Fibrillation Termination
Acute Procedural Outcomes as defined by termination of Atrial Fibrillation into normal sinus rhythm (NSR) or atrial tachycardia (AT)
Time frame: Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| De Novo | Number of Participants With Atrial Fibrillation Termination | 23 Participants |
| Re-Do Ablation | Number of Participants With Atrial Fibrillation Termination | 12 Participants |
Secondary
Duration of Exposure
Radiation exposure due to fluoroscopy during the AF ablation procedure
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| De Novo | Duration of Exposure | 245 mGy | Standard Deviation 201 |
| Re-Do Ablation | Duration of Exposure | 241 mGy | Standard Deviation 197 |
Secondary
Duration of Fluoro Time
Duration of fluoroscopy used during the AF ablation procedure
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| De Novo | Duration of Fluoro Time | 25.5 minutes | Standard Deviation 13.1 |
| Re-Do Ablation | Duration of Fluoro Time | 24.1 minutes | Standard Deviation 9 |
Secondary
Duration of Procedure Time
Duration of RADAR procedure time
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| De Novo | Duration of Procedure Time | 23.6 minutes | Standard Deviation 20.3 |
| Re-Do Ablation | Duration of Procedure Time | 34.5 minutes | Standard Deviation 19.3 |
Secondary
Duration of RF Ablation
Amount of radiofrequency ablation used for atrial fibrillation ablation
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| De Novo | Duration of RF Ablation | 323 minutes | Standard Deviation 141.5 |
| Re-Do Ablation | Duration of RF Ablation | 316 minutes | Standard Deviation 88.56 |
Secondary
Number of Major Adverse Cardiac Events (MACE)
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| De Novo | Number of Major Adverse Cardiac Events (MACE) | 1 events |
| Re-Do Ablation | Number of Major Adverse Cardiac Events (MACE) | 1 events |
Secondary
Number of Procedure-related Adverse Events
Time frame: up to 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| De Novo | Number of Procedure-related Adverse Events | 7 events |
| Re-Do Ablation | Number of Procedure-related Adverse Events | 4 events |
Secondary
Number of Serious Adverse Events
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| De Novo | Number of Serious Adverse Events | 12 events |
| Re-Do Ablation | Number of Serious Adverse Events | 8 events |
Secondary
Rate of Post-ablation Inducibility of AF
Post-ablation inducibility of AF (\> 5 mins) with burst pacing
Time frame: Day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| De Novo | Rate of Post-ablation Inducibility of AF | 61 percent of occurences |
| Re-Do Ablation | Rate of Post-ablation Inducibility of AF | 46 percent of occurences |