Paroxysmal Atrial Fibrillation
Conditions
Keywords
Interventional, Radiofrequency Ablation, Paroxysmal Atrial Fibrillation
Brief summary
The QDOT-FAST study is a prospective, multi-center, non-randomized, interventional clinical study.
Detailed description
The purpose of this study is to evaluate safety and acute performance of the THERMOCOOL SMARTTOUCH® SF-5D catheter used in combination with the nMARQ™ Multi-Channel RF Generator with TGA mode in the treatment of Paroxysmal Atrial Fibrillation (PAF) during standard electrophysiology mapping and RF ablation procedures. The QDOT-FAST study is a prospective, multi-center, non-randomized, interventional clinical study.
Interventions
DEVICETHERMOCOOL SMARTTOUCH SF-5D Catheter
radiofrequence ablation with THERMOCOOL SMARTTOUCH® SF-5D catheter used in combination with the nMARQ™ Multi-Channel RF Generator with TGA mode
Sponsors
Biosense Webster, Inc.
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
1. Age 18 or older. 2. Signed the Patient Informed Consent Form (ICF). 3. Diagnosed with symptomatic PAF 4. Selected for catheter ablation through pulmonary vein isolation. 5. Able and willing to comply with all pre-, post-, and follow-up testing and requirements (e.g. patient not confined by a court ruling).
Exclusion criteria
1. Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause. 2. Previous surgical or catheter ablation for atrial fibrillation. 3. Previously diagnosed with persistent, longstanding AF and/or continuous AF \>7 days, or \>48 hrs. terminated by cardioversion. 4. Documented Left Atrial thrombus on baseline/pre-procedure imaging. 5. Any carotid stenting or endarterectomy. 6. Left atrial (LA) size \>50mm. 7. Left Ventricular ejection fraction (LVEF) \<40%. 8. Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV. 9. History of blood clotting or bleeding abnormalities 10. Contraindication to anticoagulation 11. History of a documented thromboembolic event (including transient ischemic attack (TIA)) within the past 12 months. 12. Previous percutaneous coronary intervention (PCI) or myocardial Infarction (MI) within the past 2 months. 13. Coronary artery bypass grafting (CABG) in conjunction with valvular surgery, cardiac surgery (e.g. ventriculotomy, atriotomy) or valvular cardiac (surgical or percutaneous) procedure. 14. Rheumatic Heart Disease 15. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months. 16. Unstable angina. 17. Significant pulmonary disease (e.g. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other diseaseor malfunction of the lungs or respiratory system that produces chronic symptoms. 18. Acute illness, active systemic infection, or sepsis. 19. Presence of atrial myxoma, interatrial baffle or patch 20. Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation. 21. Presence of a condition that precludes vascular access. 22. Presence of implanted pacemaker or implantable cardioverter-defibrillator (ICD). 23. Presence of IVC filter 24. Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this trial. 25. Currently enrolled in an investigational study evaluating another device, biologic, or drug. 26. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child bearing age and plan on becoming pregnant during the course of the clinical investigation. 27. Life expectancy or other disease processes likely to limit survival to less than 12 months. 28. Presenting contra-indication for the devices used in the study, as indicated in the respective instructions for use. 29. Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being 30. Contraindication to use of contrast agents for MRI such as advanced renal disease, etc. (at PI discretion) 31. Presence of iron-containing metal fragments in the body 32. Unresolved pre-existing neurological deficit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Achieved Acute Procedural Success | Day 1 | Defined acute procedural success as confirmation of entrance block in all targeted pulmonary veins after adenosine or isoproterenol challenge. |
| Incidence of Acute Safety | 7 days post-procedure | Defined as the incidence of early-onset predefined primary adverse events within 7 days of the study procedure, including atrio-eophageal fistula, phrenic nerve paralysis , cardiac tamponade/perforation , pulmonary vein stenosis, death, stroke/CVA, major vascular access complication/bleeding , thromboembolism, myocardial infarction, transient ischemic attack. Device or procedure related death, pulmonary vein stenosis and atrio-esophageal fistula that occur beyond 7 days post- procedure were also be deemed primary AEs. |
Countries
Austria, Belgium, Czechia, Italy
Participant flow
Recruitment details
A total of 54 subjects were enrolled in the study at 7 sites in Europe. The first subject was enrolled on April 17th, 2018 and the last subject was enrolled on June 20th, 2018.
Pre-assignment details
Subjects were screened carefully prior to enrollment in the study to ensure compliance with the inclusion and exclusion criteria. All subjects were screened using pre-procedure imaging for the presence of LA thrombus, which was intended to decrease the potential for thromboembolic complications.
Participants by arm
| Arm | Count |
|---|---|
| THERMOCOOL SMARTTOUCH SF-5D Catheter A novel radiofrequency ablation catheter combining microelectrodes, thermocouples, porous tip irrigation and contact force sensing nMARQ Multi-Channel RF Generator with Software including temperature guided ablation mode. | 54 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Subject didn't receive study catheter | 2 |
Baseline characteristics
| Characteristic | THERMOCOOL SMARTTOUCH SF-5D Catheter | — |
|---|---|---|
| Age, Continuous | 62.0 Years STANDARD_DEVIATION 12.01 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment European Union | 54 Participants | — |
| Sex: Female, Male Female | 18 Participants | — |
| Sex: Female, Male Male | 36 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 52 |
| other Total, other adverse events | 32 / 52 |
| serious Total, serious adverse events | 4 / 52 |
Outcome results
Primary
Incidence of Acute Safety
Defined as the incidence of early-onset predefined primary adverse events within 7 days of the study procedure, including atrio-eophageal fistula, phrenic nerve paralysis , cardiac tamponade/perforation , pulmonary vein stenosis, death, stroke/CVA, major vascular access complication/bleeding , thromboembolism, myocardial infarction, transient ischemic attack. Device or procedure related death, pulmonary vein stenosis and atrio-esophageal fistula that occur beyond 7 days post- procedure were also be deemed primary AEs.
Time frame: 7 days post-procedure
Population: Effectiveness population includes all subjects who have had the investigational device inserted and underwent ablation with the study catheter used in conjunction with QMode+ for pulmonary vein isolation (PVI). Subjects without any QMode+ application for PVI are excluded from the effectiveness population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| THERMOCOOL SMARTTOUCH SF-5D Catheter | Incidence of Acute Safety | 2 Participants |
Primary
Number of Subjects Achieved Acute Procedural Success
Defined acute procedural success as confirmation of entrance block in all targeted pulmonary veins after adenosine or isoproterenol challenge.
Time frame: Day 1
Population: Effectiveness population includes all subjects who have had the investigational device inserted and underwent ablation with the study catheter used in conjunction with QMode+ for pulmonary vein isolation (PVI). Subjects without any QMode+ application for PVI are excluded from the effectiveness population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| THERMOCOOL SMARTTOUCH SF-5D Catheter | Number of Subjects Achieved Acute Procedural Success | 52 Participants |