Atrial Fibrillation
Conditions
Keywords
Interventional, Radiofrequency ablation, Paroxysmal Atrial Fibrillation, Catheter ablation
Brief summary
This is a prospective effectiveness and safety assessment of the study device during radiofrequency (RF) ablation treatment of patients with drug refractory symptomatic atrial fibrillation.
Detailed description
The purpose of this study is to assess the effectiveness and safety of the THERMOCOOL® SMARTTOUCH™ catheter in the treatment of drug refractory symptomatic paroxysmal atrial fibrillation (PAF) undergoing CPVI.
Interventions
DEVICETHERMOCOOL® SMARTTOUCH™
Pulmonary vein isolation by RF ablation treatment with the THERMOCOOL® SMARTTOUCH™ contact force sensing catheters (study device)
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 years or older 2. Failure of at least one antiarrhythmic drug (AAD) for AF (class I or III, or AV nodal blocking agents such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic AF, or intolerance to the AAD 3. Patients with paroxysmal AF eligible for catheter ablation 4. Patients with symptomatic PAF who have had at least one documented AF episode in the twelve (12) months prior to enrollment. Documentation may include but is not limited to electrocardiogram (ECG), Holter monitor (HM) or transtelephonic monitor (TTM) 5. Able and willing to comply with all pre-, post- and follow-up testing and requirements 6. Be able to sign IRB/EC-approved informed consent form
Exclusion criteria
1. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause 2. Previous surgical or catheter ablation for AF 3. Any PCI, cardiac surgery, or valvular cardiac surgical or percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repart or replacement and presence of a prosthetic valve) within the past 2 months. 4. Any carotid stenting or endarterectomy. 5. Coronary artery bypass graft (CABG) procedure within the last 180 days (6 months) 6. AF episodes lasting longer than 7 days or terminated via cardioversion 7. Documented left atrial thrombus on imaging 8. Uncontrolled heart Failure or New York Heart Association (NYHA) class III or IV 9. Myocardial Infarction within the previous 60 days (2 months) 10. Documented thromboembolic event (including TIA) within the past 12 months 11. Rheumatic heart disease 12. Awaiting cardiac transplantation or other cardiac surgery within the next 365 days (12 months) 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. Active illness or active systemic infection or sepsis 16. Diagnosed atrial myxoma 17. Unstable angina within the past 60 days (2 months) 18. History of blood clotting or bleeding abnormalities 19. Life expectancy less than 365 days (12 months) 20. Hypertrophic obstructive cardiomyopathy 21. Presence of implanted ICD 22. Contraindication to anticoagulation 23. Contraindication to isoproterenol 24. Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation 25. Women who are pregnant and/or breast feeding 26. Presence of a condition that precludes vascular access. 27. Patients presenting contraindications for study catheter(s), as indicated in the respective Instructions For Use 28. Enrollment in an investigational study evaluating another device, biologic, or drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Freedom From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes | 12 Months | The primary effectiveness endpoint for this study is freedom from documented symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 12-month follow-up after the index ablation procedure (includes a three-month blanking period). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Where Acute Success Was Achieved | 0.5 hours | Confirmation of entrance block in all pulmonary veins (PVs) with an isoproterenol intravenous challenge 0.5h post procedure. Exit Block is optional for this study. |
| Average Contact Force Per Pulmonary Vein Ablation Procedure | 1 day during procedure | Contact force (CF) is the force (g) between the device tip and endocardial wall. Two subjects didn't have CF data |
| Percent of Subjects With Pulmonary Vein Reconnection for the Index Procedure | 1 day during procedure | Percentage of subjects with PV reconnection after the first ablation |
| Procedure Time, Ablation Time and Fluoroscopy Time | 1 day during procedure | Procedure Time, Ablation Time and Fluoroscopy Time in minutes |
Participant flow
Recruitment details
A total of 201 patients from 12 sites in China were screened and 200 patients were enrolled into the study.
Pre-assignment details
This was a prospective, multicenter, non-randomized clinical study. Patients were enrolled to receive THERMOCOOL® SMARTTOUCHTM catheter if signed informed consent forms and satisfied the study inclusion and exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| THERMOCOOL® SMARTTOUCH™ Family of Catheters Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® SMARTTOUCH™ contact force sensing catheters (study device) | 200 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 11 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | THERMOCOOL® SMARTTOUCH™ Family of Catheters |
|---|---|
| Age, Continuous | 61.2 Years STANDARD_DEVIATION 9.25 |
| Race/Ethnicity, Customized Han Nationality | 198 Participants |
| Race/Ethnicity, Customized Others: Hui Nationality | 2 Participants |
| Sex: Female, Male Female | 75 Participants |
| Sex: Female, Male Male | 125 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 200 |
| other Total, other adverse events | 28 / 200 |
| serious Total, serious adverse events | 26 / 200 |
Outcome results
Primary
Percentage of Patients With Freedom From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes
The primary effectiveness endpoint for this study is freedom from documented symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 12-month follow-up after the index ablation procedure (includes a three-month blanking period).
Time frame: 12 Months
Population: Per protocol population: Subjects in the ITT Population who undergone insertion of the study catheter and AF ablation procedure, and had the 12th month primary efficacy endpoint data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| THERMOCOOL® SMARTTOUCH™ Family of Catheters | Percentage of Patients With Freedom From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes | 80.7 Percentage of Participants |
95% CI: [73.9, 86.4]
Secondary
Average Contact Force Per Pulmonary Vein Ablation Procedure
Contact force (CF) is the force (g) between the device tip and endocardial wall. Two subjects didn't have CF data
Time frame: 1 day during procedure
Population: Safety population with contact force data available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THERMOCOOL® SMARTTOUCH™ Family of Catheters | Average Contact Force Per Pulmonary Vein Ablation Procedure | 12.9 Grams | Standard Deviation 3.79 |
Secondary
Percentage of Patients Where Acute Success Was Achieved
Confirmation of entrance block in all pulmonary veins (PVs) with an isoproterenol intravenous challenge 0.5h post procedure. Exit Block is optional for this study.
Time frame: 0.5 hours
Population: Safety Population, i.e., all enrolled subjects who undergone insertion of the study catheter during the procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| THERMOCOOL® SMARTTOUCH™ Family of Catheters | Percentage of Patients Where Acute Success Was Achieved | 99.5 Percentage of participants |
95% CI: [97.2, 100]
Secondary
Percent of Subjects With Pulmonary Vein Reconnection for the Index Procedure
Percentage of subjects with PV reconnection after the first ablation
Time frame: 1 day during procedure
Population: Safety population with pulmonary vein reconnection data available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| THERMOCOOL® SMARTTOUCH™ Family of Catheters | Percent of Subjects With Pulmonary Vein Reconnection for the Index Procedure | 7.5 Percentage of participants |
Secondary
Procedure Time, Ablation Time and Fluoroscopy Time
Procedure Time, Ablation Time and Fluoroscopy Time in minutes
Time frame: 1 day during procedure
Population: Safety population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| THERMOCOOL® SMARTTOUCH™ Family of Catheters | Procedure Time, Ablation Time and Fluoroscopy Time | Duration of Procedure (min) | 144.5 Minutes | Standard Deviation 41.28 |
| THERMOCOOL® SMARTTOUCH™ Family of Catheters | Procedure Time, Ablation Time and Fluoroscopy Time | Duration of Ablation (min) | 63.5 Minutes | Standard Deviation 36.15 |
| THERMOCOOL® SMARTTOUCH™ Family of Catheters | Procedure Time, Ablation Time and Fluoroscopy Time | Total Duration of Fluoroscopy (min) | 15.6 Minutes | Standard Deviation 10.02 |