Atrial Fibrillation
Conditions
Keywords
atrial fibrillation, ablation
Brief summary
The overall goal of this project is to test the feasibility of performing real-time electrogram morphology recurrence (EMR) mapping in patients with persistent atrial fibrillation (AF) to locate areas of high electrogram morphology recurrence rate. The Investigator believe that the EMR mapping can be integrated into cardiac mapping and used to identify potential sites for ablation. Furthermore, this study could help demonstrate the efficacy of this technology's ability to terminate or slow AF. The Investigator will test this technology on ten subjects undergoing a second ablation procedure. The Investigator will map the AF utilizing the EMR to indicate locations of stable activity and ablate the area. The Investigator believes that the study could produce acute AF termination or AF cycle length slowing. In addition to testing the real-time electrogram morphology recurrence mapping, the study would also like to determine the acute effects of radiofrequency ablation of areas of high recurrence rates and determine long term freedom from AF following ablation of areas of high recurrence rates.
Interventions
DEVICEElectrogram Morphology Mapping (EMR)
Fifteen second AF recordings will be made using a multipolar electrode catheter to map the entire right atrium & then the left atrium.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Jeffrey Goldberger
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female at least 21 years of age * persistent Afib with one prior failed ablation for persistent or long standing persistent Afib
Exclusion criteria
* Inability to sign consent * Patients with a life expectancy less than one (1) year * Patients with chronic kidney disease with sufficiently low GFR that precludes either CT angiogram of the heart or contrast MRI study * Pregnant women and women that are breast feeding * Patients with multiple (2 or more) prior failed ablations * Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Real-time Electrogram Morphology Recurrence (EMR) Mapping Feasibility | 2 hours | As measured by number of patients where real-time EMR mapping is completed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ablation Acute Effects | 2 hours | ablation based on EMR map as measured by number of participants that terminate atrial fibrillation. |
| Number of Participants With Treatment Emergent Adverse Events | 30 days | Number of participants with treatment emergent adverse events will be measured by the type of adverse event, severity, and whether the AE/SAE is related to the mapping |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EMR Feasibility In this feasibility study, all ten patients will undergo EMR mapping which will be used to guide ablation.
Electrogram Morphology Mapping (EMR): Fifteen second AF recordings will be made using a multipolar electrode catheter to map the entire right atrium & then the left atrium. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | EMR Feasibility |
|---|---|
| Age, Continuous | 63.4 years STANDARD_DEVIATION 7.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 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 | 10 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 2 / 10 |
| serious Total, serious adverse events | 1 / 10 |
Outcome results
Primary
Real-time Electrogram Morphology Recurrence (EMR) Mapping Feasibility
As measured by number of patients where real-time EMR mapping is completed.
Time frame: 2 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EMR Feasibility | Real-time Electrogram Morphology Recurrence (EMR) Mapping Feasibility | 10 Participants |
Secondary
Ablation Acute Effects
ablation based on EMR map as measured by number of participants that terminate atrial fibrillation.
Time frame: 2 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EMR Feasibility | Ablation Acute Effects | 0 Participants |
Secondary
Ablation Acute Effects
ablation based on EMR map as measured by number of participants that slow atrial fibrillation cycle length by at least 15%.
Time frame: 2 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EMR Feasibility | Ablation Acute Effects | 3 Participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events
Number of participants with treatment emergent adverse events will be measured by the type of adverse event, severity, and whether the AE/SAE is related to the mapping
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EMR Feasibility | Number of Participants With Treatment Emergent Adverse Events | 2 Participants |