Atrial Fibrillation
Conditions
Keywords
Interventional, Radiofrequency Ablation, Paroxysmal Atrial Fibrillation
Brief summary
The QDOT-Micro study is a prospective, multi-center, non-randomized, interventional clinical study.
Detailed description
The purpose of this study is to evaluate the workflow and acute performance , during standard electrophysiology mapping and RF ablation procedures, of the THERMOCOOL SMARTTOUCH® SF-5D catheter with temperature sensing capabilities and micro electrodes used in combination with the CARTO® 3 Navigation System with THERMOCOOL SMARTTOUCH® SF-5D-module.
Interventions
DEVICETHERMOCOOL SMARTTOUCH® SF-5D catheter
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
Candidates for this study must meet ALL of the following criteria: 1. Age 18 or older 2. Patients who have signed the Patient Informed Consent Form (ICF) 3. Subjects diagnosed with symptomatic documented PAF\* who are candidates for catheter ablation 4. Able and willing to comply with all pre-, post-, and follow-up testing and requirements (eg. Patient not confined by a court ruling)
Exclusion criteria
Candidates for this study will be EXCLUDED from the study if ANY of the following conditions apply: 1. Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause. 2. Previous ablation for atrial fibrillation. 3. Previously diagnosed with persistent AF. 4. Documented Left Atrial thrombus 5. Any carotid stenting or endarterectomy 6. LA size \>50mm 7. LVEF \<40% 8. Uncontrolled heart failure or NYHA function class III and IV 9. History of blood clotting or bleeding abnormalities or contraindication to anticoagulation ( heparin, warfarin, or dabigatran) 10. History of a documented thromboembolic event (including TIA) within the past 12 months. 11. Previous PCI/MI within the past 3 months 12. Previous cardiac surgery (e.g CABG) in conjunction with valve surgery or any valvular cardiac surgical/percutaneous procedure (e.g ventriculotomy, atriomy, valve repair or replacement, presence of a prosthetic valve) within the past 6 months. 13. Awaiting cardiac transplantation or other cardiac surgery within the next 6 months. 14. Unstable angina 15. Significant pulmonary disease (eg, 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. 16. Acute illness, active systemic infection, or sepsis. 17. Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation. 18. Presence of a condition that precludes vascular access. 19. Presence of implantable cardioverter-defibrillator (ICD) 20. Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this trial. 21. Currently enrolled in an investigational study evaluating another device, biologics, or drug. 22. Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the clinical investigation (as evidenced by pregnancy test if of child bearing potential). 23. Life expectancy less than 12 months. 24. Presenting contra-indication for the devices used in the study, as indicated in the respective instructions for use.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Entrance Block Confirmation in the Total Effectiveness Outcome Population | Day of ablation procedure | Confirmation of entrance block in all targeted PVs after adenosine and/or isoproterenol challenge achieved at the end of procedure. If the challenge was not done, confirmation data would not be available. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Early Onset Primary Adverse Events in Total Safety Population | Seven Days Post Procedure | Primary adverse events include Death, Atrio-Esophageal Fistula, Cardiac Tamponade/Perforation, Myocardial Infarction, Stroke/Cerebrovascular Accident, Thromboembolism, Transient Ischemic Attack, Diaphragmatic Paralysis, Pneumothorax, Heart Block, Pulmonary Vein Stenosis, Pulmonary Edema (Respiratory Insufficiency), Vagal Nerve Injury, Pericarditis, Major Vascular Access Complication/Bleeding, Pulmonary vein (PV) stenosis and atrio-esophageal fistula |
Participant flow
Recruitment details
A total of 51 subjects were enrolled in the study at 6 sites in Europe. The first subject was enrolled on September 28th, 2016 and the last subject was enrolled on April 26th, 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 had pre-procedure imaging to screen for the presence of left atrial appendage thrombus to decrease the potential for thromboembolic complications.
Participants by arm
| Arm | Count |
|---|---|
| THERMOCOOL SMARTTOUCH® SF-5D The THERMOCOOL SMARTTOUCH® SF-5D Catheter with improved temperature sensing capabilities and micro electrodes and CARTO®3 V6 technology | 51 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Subject didn't meet eligibility criteria | 2 |
| Overall Study | Subject excluded before study procedure | 1 |
Baseline characteristics
| Characteristic | THERMOCOOL SMARTTOUCH® SF-5D | — |
|---|---|---|
| Age, Continuous | 61.3 Years STANDARD_DEVIATION 11.92 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment European Union | 51 Participants | — |
| Sex: Female, Male Female | 19 Participants | — |
| Sex: Female, Male Male | 32 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 22 / 50 |
| serious Total, serious adverse events | 7 / 50 |
Outcome results
Primary
Number of Participants With Entrance Block Confirmation in the Total Effectiveness Outcome Population
Confirmation of entrance block in all targeted PVs after adenosine and/or isoproterenol challenge achieved at the end of procedure. If the challenge was not done, confirmation data would not be available.
Time frame: Day of ablation procedure
Population: This total effectiveness outcome population includes all subjects (under both protocols v1.0 and v2.0), complied with study inclusion and exclusion criteria, received investigational device, and had an adenosine challenge applied for verifying entrance block.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| THERMOCOOL SMARTTOUCH® SF-5D | Number of Participants With Entrance Block Confirmation in the Total Effectiveness Outcome Population | Subjects with entrance block confirmation | 46 Participants |
| THERMOCOOL SMARTTOUCH® SF-5D | Number of Participants With Entrance Block Confirmation in the Total Effectiveness Outcome Population | Subjects without entrance block confirmation | 1 Participants |
Secondary
Number of Participants With Early Onset Primary Adverse Events in Total Safety Population
Primary adverse events include Death, Atrio-Esophageal Fistula, Cardiac Tamponade/Perforation, Myocardial Infarction, Stroke/Cerebrovascular Accident, Thromboembolism, Transient Ischemic Attack, Diaphragmatic Paralysis, Pneumothorax, Heart Block, Pulmonary Vein Stenosis, Pulmonary Edema (Respiratory Insufficiency), Vagal Nerve Injury, Pericarditis, Major Vascular Access Complication/Bleeding, Pulmonary vein (PV) stenosis and atrio-esophageal fistula
Time frame: Seven Days Post Procedure
Population: Total Safety Population: includes subjects enrolled under CIP v1.0 and 2.0 who underwent study procedure with investigational device.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| THERMOCOOL SMARTTOUCH® SF-5D | Number of Participants With Early Onset Primary Adverse Events in Total Safety Population | Subjects with Pericard. effusion without tamponade | 1 Participants |
| THERMOCOOL SMARTTOUCH® SF-5D | Number of Participants With Early Onset Primary Adverse Events in Total Safety Population | Subjects with Pericarditis | 1 Participants |
| THERMOCOOL SMARTTOUCH® SF-5D | Number of Participants With Early Onset Primary Adverse Events in Total Safety Population | Subjects with Vascular pseudoaneurysm | 1 Participants |
| THERMOCOOL SMARTTOUCH® SF-5D | Number of Participants With Early Onset Primary Adverse Events in Total Safety Population | Subjects without primary adverse events | 47 Participants |