Atrial Fibrillation
Conditions
Keywords
nMARQ, Atrial Fibrillation, Drug Refractory, Radio Frequency
Brief summary
To demonstrate safety and effectiveness of nMARQ Catheter System \[nMARQ\] compared with THERMOCOOL® Navigational Family of catheters in treating subjects with drug-refractory symptomatic paroxysmal atrial fibrillation (PAF).
Interventions
DEVICEnMARQ Navigation Catheters
DEVICENaviStar ThermoCool Catheters
Sponsors
Biosense Webster, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with symptomatic paroxysmal AF who have had at least one AF episode documented within one (1) year prior to enrollment. Documentation may include ECG, transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip. 2. Patients who have failed at least one antiarrhythmic drug (AAD; class I or III, or atrioventricular (AV) nodal blocking agents such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic AF, or intolerance to the AAD. 3. Pre-procedure anticoagulation on warfarin, rivaroxaban, or apixaban. 4. Age 18 years or older. 5. Signed Patient Informed Consent Form (ICF). 6. Able and willing to comply with all pre-, post-, and follow-up testing and requirements.
Exclusion criteria
1. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause. 2. Previous ablation for atrial fibrillation. 3. Patients on amiodarone at any time during the past 3 months prior to enrollment. 4. AF episodes lasting \> 7 days. 5. Any cardiac surgery within the past 60 days (2 months). 6. Any valvular cardiac surgical procedure (i.e., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve). 7. Coronary artery bypass graft (CABG) procedure within the last 180 days (6 months). 8. Awaiting cardiac transplantation or other cardiac surgery within the next 365 days (12 months). 9. Documented left atrial thrombus on imaging. 10. History of a documented thromboembolic event within the past one (1) year. 11. Diagnosed atrial myxoma. 12. Presence of implanted cardioverter defibrillator (ICD). 13. Significant pulmonary disease, (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms. 14. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study. 15. Women who are pregnant (as evidenced by pregnancy test if subject is of child-bearing age and potential) or breast feeding. 16. Acute illness or active systemic infection or sepsis. 17. Unstable angina. 18. Myocardial infarction within the previous 60 days (2 months). 19. Left ventricular ejection fraction \<40%. 20. History of blood clotting or bleeding abnormalities. 21. Contraindication to anticoagulation (i.e., heparin, dabigatran, Vitamin K Antagonists such as warfarin). 22. Life expectancy less than 365 days (12 months). 23. Enrollment in an investigational study evaluating another device or drug. 24. Uncontrolled heart failure or NYHA Class III or IV heart failure. 25. Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation. 26. Presence of a condition that precludes vascular access. 27. Left atrial size \>50 mm.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Early Onset Primary Adverse Events | 30 days post-procedure | The primary safety endpoint was the incidence of early-onset primary adverse events within 7 days post the AF ablation procedure; Pulmonary vein stenosis and atrio-esophageal fistula that occurred beyond 7 days post-procedure and development of a significant pericardial effusion within 30 days post-procedure were also considered primary AEs |
| Incidence of Early Onset Primary Adverse Events for the Intent-to-Treat and As-Treated Population | 30 days post-procedure | The primary safety endpoint was the incidence of early-onset primary adverse events within 7 days post the AF ablation procedure; Pulmonary vein stenosis and atrio-esophageal fistula that occurred beyond 7 days post-procedure and development of a significant pericardial effusion within 30 days post-procedure were also considered primary AEs |
Participant flow
Recruitment details
The first subject was enrolled on April 1, 2013. Enrollment was terminated on May 25, 2017.
Pre-assignment details
This was a prospective, multicenter, randomized, controlled, two arm single-blind design. Enrolled subjects N=481 (subjects signed informed consent) 468 does not include 13 subjects excluded prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| nMARQ® Group Pulmonary vein isolation by radiofrequency ablation treatment with the nMARQ® catheter. | 174 |
| THERMOCOOL® Group Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® catheter. | 169 |
| Roll-in Subjects Calibration roll-in cohort | 125 |
| Total | 468 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 3 | 2 | 4 |
| Overall Study | Discontinued Subjects | 1 | 1 | 2 |
| Overall Study | Early Termination | 1 | 1 | 3 |
| Overall Study | Excluded Subjects(No catheter inserted) | 23 | 20 | 21 |
| Overall Study | Lost to Follow-up | 0 | 9 | 3 |
| Overall Study | Withdrawn due to Study Termination | 91 | 83 | 41 |
Baseline characteristics
| Characteristic | nMARQ® Group | THERMOCOOL® Group | Roll-in Subjects | Total |
|---|---|---|---|---|
| Age, Continuous | 62.0 Years STANDARD_DEVIATION 10.81 | 61.8 Years STANDARD_DEVIATION 10.4 | 63.6 Years STANDARD_DEVIATION 9.96 | 62.4 Years STANDARD_DEVIATION 10.41 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 3 Participants | 5 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 168 Participants | 165 Participants | 120 Participants | 453 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) White | 169 Participants | 165 Participants | 121 Participants | 455 Participants |
| Sex: Female, Male Female | 66 Participants | 60 Participants | 50 Participants | 176 Participants |
| Sex: Female, Male Male | 108 Participants | 109 Participants | 75 Participants | 292 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 151 | 2 / 149 | 4 / 104 |
| other Total, other adverse events | 86 / 151 | 86 / 149 | 74 / 104 |
| serious Total, serious adverse events | 38 / 151 | 25 / 149 | 31 / 104 |
Outcome results
Primary
Incidence of Early Onset Primary Adverse Events for the Intent-to-Treat and As-Treated Population
The primary safety endpoint was the incidence of early-onset primary adverse events within 7 days post the AF ablation procedure; Pulmonary vein stenosis and atrio-esophageal fistula that occurred beyond 7 days post-procedure and development of a significant pericardial effusion within 30 days post-procedure were also considered primary AEs
Time frame: 30 days post-procedure
Population: The Intent-to-Treat and As-Treated population which includes randomized patients who have the ablation catheter inserted
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| nMARQ® Group | Incidence of Early Onset Primary Adverse Events for the Intent-to-Treat and As-Treated Population | 8 Participants |
| ThermoCool Group | Incidence of Early Onset Primary Adverse Events for the Intent-to-Treat and As-Treated Population | 7 Participants |
Primary
Number of Participants With Early Onset Primary Adverse Events
The primary safety endpoint was the incidence of early-onset primary adverse events within 7 days post the AF ablation procedure; Pulmonary vein stenosis and atrio-esophageal fistula that occurred beyond 7 days post-procedure and development of a significant pericardial effusion within 30 days post-procedure were also considered primary AEs
Time frame: 30 days post-procedure
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| nMARQ® Group | Number of Participants With Early Onset Primary Adverse Events | 8 Participants |
| ThermoCool Group | Number of Participants With Early Onset Primary Adverse Events | 7 Participants |
| Roll-in Subjects | Number of Participants With Early Onset Primary Adverse Events | 9 Participants |