Atrial Fibrillation
Conditions
Keywords
Interventional, Radiofrequency ablation, Paroxysmal Atrial Fibrillation
Brief summary
This is a prospective safety assessment of the study device during radiofrequency (RF) ablation treatment of patients with drug refractory symptomatic atrial fibrillation (SMART-SF).
Detailed description
The purpose of this study is to demonstrate the safety of the study device in the treatment of drug refractory symptomatic paroxysmal atrial fibrillation (PAF) during standard electrophysiology mapping and RF ablation procedures.
Interventions
DEVICETHERMOCOOL® SMARTTOUCH® (RF ablation treatment)
Radiofrequency Ablation Treatment
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
* Symptomatic paroxysmal atrial fibrillation (AF) who have had at least one AF episode electrocardiographically documented within one (1) year prior to enrollment and a physician's note indicating recurrent, self-terminating AF. Electrocardiographic documentation may include, but is not limited to, electrocardiogram (ECG), transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip * 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 intolerable to the AAD * Age 18 years or older
Exclusion criteria
* Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause * Previous surgical or catheter ablation for atrial fibrillation * Amiodarone at any time during the past 3 months * Any percutaneous coronary intervention (PCI), cardiac surgery, or valvular cardiac surgical or percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve) within the past 2 months * Any carotid stenting or endarterectomy * Coronary artery bypass graft (CABG) surgery within the past 6 months * AF episodes lasting \>7 days * Documented left atrial (LA) thrombus on imaging * LA size \>50 mm * Left ventricular ejection fraction (LVEF) \< 40% * Contraindication to anticoagulation (heparin or warfarin) * History of blood clotting or bleeding abnormalities * MI within the past 2 months * Documented thromboembolic event (including transient ischemic attack (TIA)) within the past 12 months * Rheumatic Heart Disease * Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV * Awaiting cardiac transplantation or other cardiac surgery within the next 12 months * Unstable angina * Acute illness or active systemic infection or sepsis * Diagnosed atrial myxoma * Presence of implanted implantable cardioverter defibrillator (ICD) * 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 * Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study * Women who are pregnant (as evidenced by pregnancy test if pre-menopausal) * Enrollment in an investigational study evaluating another device, biologic, or drug * Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter * Presence of a condition that precludes vascular access * Life expectancy or other disease processes likely to limit survival to less than 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Early Onset Primary Adverse Events | Seven days post ablation procedure | Early onset is defined as within 7 days of the atrial fibrillation (AF) ablation procedure. Primary adverse events (AE) include Death, Myocardial infarction (MI), Pulmonary vein (PV) stenosis, Diaphragmatic paralysis, Atrio-esophageal fistula, Transient Ischemic Attack (TIA), Stroke / Cerebrovascular accident (CVA), Thromboembolism, Pericarditis, Cardiac Tamponade / Perforation, Pneumothorax, Major Vascular Access Complications / Bleeding, Pulmonary edema (Respiratory Insufficiency), and Heart block. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Non-Primary Serious Adverse Events (SAEs) | Up to 30 days post Procedure | This secondary safety endpoint includes non-primary serious adverse events (SAEs) within 7 days post-procedure and serious adverse events from 8 days to 30 days post-procedure |
| Percentage of Participants With Acute Success | End of procedure | Acute success is defined as confirmation of entrance block in all Pulmonary veins (PV). |
| Effectiveness Endpoint: Freedom From Documented Atrial Fibrillation (AF)/Atrial Tachycardia (AT)/Atrial Flutter (AFL) | 12 months | The freedom from documented AF/AT/AFL based on electrocardiographic data |
Participant flow
Recruitment details
This study enrolled 165 subjects at 17 clinical sites in the U.S. over approximately 5 months. The first subject was enrolled on March 30, 2015 and the last subject was enrolled on September 9, 2015. The last ablation procedure was on September 17, 2015. The last 1-month follow-up visit occurred on November 3, 2015.
Participants by arm
| Arm | Count |
|---|---|
| THERMOCOOL SMARTTOUCH® SF Family of Catheters Pulmonary vein isolation by radiofrequency (RF) ablation treatment with the THERMOCOOL® SMARTTOUCH® SF family of contact force sensing catheters (study device) | 164 |
| Total | 164 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Never treated with study catheter | 6 |
| Overall Study | Not meeting eligibility | 4 |
Baseline characteristics
| Characteristic | THERMOCOOL SMARTTOUCH® SF Family of Catheters |
|---|---|
| Age, Continuous Age (Years) | 62.7 Years STANDARD_DEVIATION 10.44 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 155 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 159 Participants |
| Sex: Female, Male Female | 69 Participants |
| Sex: Female, Male Male | 95 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 31 / 159 |
| serious Total, serious adverse events | 9 / 159 |
Outcome results
Primary
Percentage of Participants With Early Onset Primary Adverse Events
Early onset is defined as within 7 days of the atrial fibrillation (AF) ablation procedure. Primary adverse events (AE) include Death, Myocardial infarction (MI), Pulmonary vein (PV) stenosis, Diaphragmatic paralysis, Atrio-esophageal fistula, Transient Ischemic Attack (TIA), Stroke / Cerebrovascular accident (CVA), Thromboembolism, Pericarditis, Cardiac Tamponade / Perforation, Pneumothorax, Major Vascular Access Complications / Bleeding, Pulmonary edema (Respiratory Insufficiency), and Heart block.
Time frame: Seven days post ablation procedure
Population: The modified intent-to-treat (mITT) population was used, which consisted of enrolled subjects who met the eligibility criteria and had the study catheter inserted.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| THERMOCOOL SMARTTOUCH® SF Catheters | Percentage of Participants With Early Onset Primary Adverse Events | 2.6 Percentage of participants |
95% CI: [0.7, 6.5]
Secondary
Effectiveness Endpoint: Freedom From Documented Atrial Fibrillation (AF)/Atrial Tachycardia (AT)/Atrial Flutter (AFL)
The freedom from documented AF/AT/AFL based on electrocardiographic data
Time frame: 12 months
Population: Effectiveness per Protocol Population, which is defined as enrolled subjects who underwent RF ablation procedure with study catheter and completed the 12 month visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| THERMOCOOL SMARTTOUCH® SF Catheters | Effectiveness Endpoint: Freedom From Documented Atrial Fibrillation (AF)/Atrial Tachycardia (AT)/Atrial Flutter (AFL) | 75 Percentage of Participants |
Secondary
Percentage of Participants With Acute Success
Acute success is defined as confirmation of entrance block in all Pulmonary veins (PV).
Time frame: End of procedure
Population: Safety Population (SP), which is defined as the enrolled subjects who had the study catheter inserted.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| THERMOCOOL SMARTTOUCH® SF Catheters | Percentage of Participants With Acute Success | 96.2 Percentage of participants |
95% CI: [92, 98.6]
Secondary
Percentage of Participants With Non-Primary Serious Adverse Events (SAEs)
This secondary safety endpoint includes non-primary serious adverse events (SAEs) within 7 days post-procedure and serious adverse events from 8 days to 30 days post-procedure
Time frame: Up to 30 days post Procedure
Population: Safety Population (SP), which is defined as the enrolled subjects who had the study catheter inserted.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| THERMOCOOL SMARTTOUCH® SF Catheters | Percentage of Participants With Non-Primary Serious Adverse Events (SAEs) | Patients with SAE within 7 days post procedure | 3.1 Percentage of Participants |
| THERMOCOOL SMARTTOUCH® SF Catheters | Percentage of Participants With Non-Primary Serious Adverse Events (SAEs) | Patients with SAE during 8-30 days post-procedure | 0.6 Percentage of Participants |