Persistent Atrial Fibrillation
Conditions
Keywords
Focal Impulse and Rotor Modulation Mapping Catheter (FIRMap), Rotor, FIRM-guided procedure, REAFFIRM
Brief summary
The study is a prospective, multicenter, randomized study to assess the safety and effectiveness of FIRM procedures followed by conventional ablation including PVI versus a standard PVI procedure for the treatment of persistent atrial fibrillation (AF).
Interventions
PROCEDUREStandard PVI Ablation
Standard PVI procedure without FIRMap.
PROCEDUREFIRM-Guided Procedure and PVI
FIRM-guided procedure followed by conventional ablation including PVI.
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * At least two (2) documented episodes of persistent atrial fibrillation during prior 3 months * Refractory, intolerant, or contraindicated to Class I or III anti-arrhythmic medications * Left atrial diameter \< 6.0 cm Key
Exclusion criteria
* Previous AF Ablation * Presence of structural heart disease * New York Heart Association (NYHA) Class IV. * Ejection fraction \< 35%. * History of myocardial infarction (MI) within the past three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom From Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure | Within 7-10 days of the Procedure |
| Single-procedure Freedom From AF/AT Recurrence at 3 Month Post Index Procedure. | 3-month follow up |
| Single-procedure Freedom From AF/AT Recurrence at 3 to 12 Months Post Index Procedure. | 3-12 months post study treatment |
| Freedom From Procedure-related SAEs (Including Those Related to Any Repeat Procedures) Within 12-months of the Initial Procedure | 3 to 12 months post study treatment |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the Acute Effectiveness of FIRM-guided Procedures in Eliminating the Source of Arrhythmia as Shown by: No Evidence of the Source in FIRMap Post-op, OR Reduction of Electrogram Amplitude to < 0.2 Millivolts | Immediately post procedure |
Countries
Germany, Netherlands, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard PVI Ablation Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent AF.
Standard PVI Ablation: Standard PVI procedure without FIRMap. | 179 |
| FIRM-guided Procedure and PVI FIRM-guided procedure followed by standard catheter ablation including PVI.
FIRM-Guided Procedure and PVI: FIRM-guided procedure followed by conventional ablation including PVI. | 171 |
| Total | 350 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Death | 1 | 2 |
| Overall Study | Lost to Follow-up | 3 | 0 |
| Overall Study | Other | 2 | 0 |
| Overall Study | Physician Decision | 2 | 0 |
| Overall Study | Trial screen failure | 0 | 2 |
| Overall Study | Withdrawal by Subject | 11 | 2 |
Baseline characteristics
| Characteristic | Standard PVI Ablation | FIRM-guided Procedure and PVI | Total |
|---|---|---|---|
| Age, Continuous | 62.7 years STANDARD_DEVIATION 8.7 | 64.2 years STANDARD_DEVIATION 8.4 | 63.4 years STANDARD_DEVIATION 8.6 |
| BMI | 31.12 kg/m^2 STANDARD_DEVIATION 5.63 | 31.17 kg/m^2 STANDARD_DEVIATION 5.59 | 31.15 kg/m^2 STANDARD_DEVIATION 5.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 1 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 167 Participants | 160 Participants | 327 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants | 10 Participants | 18 Participants |
| History of significant past and/or concomitant diseases or past surgeries Cardiovascular | 72.1 % | 67.8 % | 70.0 % |
| History of significant past and/or concomitant diseases or past surgeries CNS/Neurological | 10.6 % | 11.7 % | 11.1 % |
| History of significant past and/or concomitant diseases or past surgeries Dermatologic | 5.0 % | 4.7 % | 4.9 % |
| History of significant past and/or concomitant diseases or past surgeries Drug Allergy | 3.4 % | 1.8 % | 2.6 % |
| History of significant past and/or concomitant diseases or past surgeries Endocrine/Metabolic | 37.4 % | 30.4 % | 34.0 % |
| History of significant past and/or concomitant diseases or past surgeries Eyes/Ears/Nose/Throat | 11.2 % | 12.9 % | 12.0 % |
| History of significant past and/or concomitant diseases or past surgeries Gastrointestinal | 18.4 % | 23.4 % | 20.9 % |
| History of significant past and/or concomitant diseases or past surgeries Genitourinary | 8.9 % | 12.9 % | 10.9 % |
| History of significant past and/or concomitant diseases or past surgeries Hematologic | 5.0 % | 4.1 % | 4.6 % |
| History of significant past and/or concomitant diseases or past surgeries Hepatic | 2.2 % | 2.9 % | 2.6 % |
| History of significant past and/or concomitant diseases or past surgeries Immunological | 3.9 % | 4.7 % | 4.3 % |
| History of significant past and/or concomitant diseases or past surgeries Malignancy | 5.6 % | 5.3 % | 5.4 % |
| History of significant past and/or concomitant diseases or past surgeries Musculoskeletal | 26.3 % | 28.1 % | 27.1 % |
| History of significant past and/or concomitant diseases or past surgeries Other | 21.2 % | 26.3 % | 23.7 % |
| History of significant past and/or concomitant diseases or past surgeries Psychiatric | 7.3 % | 5.8 % | 6.6 % |
| History of significant past and/or concomitant diseases or past surgeries Renal | 8.9 % | 11.1 % | 10.0 % |
| History of significant past and/or concomitant diseases or past surgeries Respiratory | 24.0 % | 22.8 % | 23.4 % |
| Hospitalizations for Cardiac Arrhythmias within 6 months of screening | 59 Participants | 48 Participants | 107 Participants |
| Largest Left Atrial Diameter | 45.63 mm STANDARD_DEVIATION 9.63 | 48.07 mm STANDARD_DEVIATION 7.65 | 46.82 mm STANDARD_DEVIATION 8.8 |
| LV Ejection Fraction | 54.5 % STANDARD_DEVIATION 8.9 | 53.8 % STANDARD_DEVIATION 8 | 54.2 % STANDARD_DEVIATION 8.5 |
| NYHA Classification Class I | 63 category | 53 category | 116 category |
| NYHA Classification Class II | 52 category | 63 category | 115 category |
| NYHA Classification Class III | 18 category | 17 category | 35 category |
| Prior and concomitant antiarrhythmic drugs (AAD) Class 2 AAD | 115 participants | 106 participants | 221 participants |
| Prior and concomitant antiarrhythmic drugs (AAD) Class 3 AAD | 67 participants | 69 participants | 136 participants |
| Prior and concomitant antiarrhythmic drugs (AAD) Class 4 AAD | 21 participants | 22 participants | 43 participants |
| Prior and concomitant antiarrhythmic drugs (AAD) Class I AAD | 29 participants | 32 participants | 61 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 6 Participants | 12 Participants |
| Race (NIH/OMB) White | 171 Participants | 159 Participants | 330 Participants |
| Region of Enrollment Germany | 72 participants | 68 participants | 140 participants |
| Region of Enrollment Netherlands | 27 participants | 23 participants | 50 participants |
| Region of Enrollment United States | 80 participants | 80 participants | 160 participants |
| Sex: Female, Male Female | 52 Participants | 45 Participants | 97 Participants |
| Sex: Female, Male Male | 127 Participants | 126 Participants | 253 Participants |
| Subjects that had LV Ejection Fraction Measured | 170 Participants | 160 Participants | 330 Participants |
| Treated for atrial fibrillation in the 6 months prior to enrollment | 85.4 % | 88.9 % | 87.1 % |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 179 | 2 / 171 |
| other Total, other adverse events | 0 / 179 | 0 / 171 |
| serious Total, serious adverse events | 19 / 179 | 28 / 171 |
Outcome results
Primary
Freedom From Procedure-related SAEs (Including Those Related to Any Repeat Procedures) Within 12-months of the Initial Procedure
Time frame: 3 to 12 months post study treatment
Population: ITT group, defined as each subject randomized to a treatment group who had a mapping and/or ablation catheter inserted
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard PVI Ablation | Freedom From Procedure-related SAEs (Including Those Related to Any Repeat Procedures) Within 12-months of the Initial Procedure | 146 Participants |
| FIRM-guided Procedure and PVI | Freedom From Procedure-related SAEs (Including Those Related to Any Repeat Procedures) Within 12-months of the Initial Procedure | 144 Participants |
p-value: 0.3522Chi-squared
Primary
Freedom From Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure
Time frame: Within 7-10 days of the Procedure
Population: Intent to Treat (ITT) group, defined as subject randomized to a treatment group who had a mapping and/or ablation catheter inserted
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard PVI Ablation | Freedom From Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure | 92.7 % of participants |
| FIRM-guided Procedure and PVI | Freedom From Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure | 88.9 % of participants |
p-value: 0.2179Chi-squared
Primary
Single-procedure Freedom From AF/AT Recurrence at 3 Month Post Index Procedure.
Time frame: 3-month follow up
Population: ITT: each subject randomized to a treatment group who had a mapping and/or ablation catheter inserted Per Protocol: those subjects in the ITT group who completed all follow-up visits and had no major protocol deviations
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard PVI Ablation | Single-procedure Freedom From AF/AT Recurrence at 3 Month Post Index Procedure. | 76.9 % of participants |
| FIRM-guided Procedure and PVI | Single-procedure Freedom From AF/AT Recurrence at 3 Month Post Index Procedure. | 71.8 % of participants |
p-value: 0.2782Chi-squared
Primary
Single-procedure Freedom From AF/AT Recurrence at 3 to 12 Months Post Index Procedure.
Time frame: 3-12 months post study treatment
Population: ITT group, defined as each subject randomized to a treatment group who had a mapping and/or ablation catheter inserted
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard PVI Ablation | Single-procedure Freedom From AF/AT Recurrence at 3 to 12 Months Post Index Procedure. | 67.5 % of participants |
| FIRM-guided Procedure and PVI | Single-procedure Freedom From AF/AT Recurrence at 3 to 12 Months Post Index Procedure. | 69.3 % of participants |
p-value: 0.7266Chi-squared
Secondary
Evaluate the Acute Effectiveness of FIRM-guided Procedures in Eliminating the Source of Arrhythmia as Shown by: No Evidence of the Source in FIRMap Post-op, OR Reduction of Electrogram Amplitude to < 0.2 Millivolts
Time frame: Immediately post procedure
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard PVI Ablation | Evaluate the Acute Effectiveness of FIRM-guided Procedures in Eliminating the Source of Arrhythmia as Shown by: No Evidence of the Source in FIRMap Post-op, OR Reduction of Electrogram Amplitude to < 0.2 Millivolts | 86.1 % of participants |