Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective, multicenter, non-randomized continued access clinical evaluation utilizing the THERMOCOOL® SMARTTOUCH™ catheter.
The device is currently under investigation with IDE #G110030. This continued access study will enroll subjects that have participated in the Smart-AF IDE study. Subjects with drug refractory symptomatic paroxysmal atrial fibrillation (PAF) will be considered for this study. Effectiveness and safety endpoints have been defined and will be evaluated post treatment.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THERMOCOOL® SMARTTOUCH™ Catheter | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THERMOCOOL® SMARTTOUCH™ Catheter | Device | AF Ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Achieved Freedom From Atrial Tachyarrhythmias | Freedom from documented symptomatic atrial fibrillation/atrial tachycardia/atrial flutter (hereinafter collectively referred to as "atrial tachyarrhythmias") based on electrocardiographic data during the effectiveness evaluation period (Day 91-361). Acute procedure failures, antiarrhythmic drug(AAD) changes and repeat ablation occurring during evaluation period were deemed as primary effectiveness failures | Day 91-361 |
| Incidence of Primary Adverse Events Within Specified Study Period | Primary safety endpoint consists of primary adverse events (AE) within 7 days post procedure Or pulmonary vein stenosis and atrio-esophageal fistula events that occurred within 12 months post-procedure. Primary adverse events include death, myocardial infarction, pulmonary vein stenosis, diaphragmatic paralysis, atrio-esophageal fistula, transient ischemic attack, stroke / cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade, pericardial effusion, pneumothorax, atrial perforation, vascular access complications, pulmonary edema, initial and prolonged hospitalization (excluding those due to pre-existing arrhythmia recurrence), heart block. | 12 months post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Peri-procedural Serious Adverse Events | Peri-procedural serious adverse events (SAEs) are those non-primary SAEs occurred within 8-30 days post procedure | Within 8-30 days post procedure |
| Percentage of Subjects Achieved Acute Effectiveness |
Not provided
Inclusion Criteria:
Exclusion Criteria including, but not limited to:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama, Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Stanford University School of Medicine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study enrolled 148 subjects at 15 clinical sites in the U.S. over the course of approximately 8 months. The first subject was enrolled on July 26, 2012, and the last subject was enrolled on March 18, 2013. The study's last index ablation procedure was on April 24, 2013.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | THERMOCOOL® SMARTTOUCH™ Catheter | THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
This study had a single arm: catheter ablation for PAF
Not provided
Not provided
Not provided
Not provided
Acute effectivenesss is defined as confirmation of entrance block into all Pulmonary veins
| 5 hours of procedure time |
| Late Onset Serious Adverse Events | Late onset serious adverse events (SAEs) are those non-primary SAEs occurred after 31 days post procedure | From 31 days post procedure to month 12 |
| Stanford |
| California |
| 94305 |
| United States |
| Florida Hospital | Orlando | Florida | 32803 | United States |
| Piedmont Heart Institute | Atlanta | Georgia | 30309 | United States |
| Loyola University Chicago | Maywood | Illinois | 60153 | United States |
| University of Kansas Hospitals | Kansas City | Kansas | 66160 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Mayo Clinic | Rochester | Minnesota | 55902 | United States |
| The Valley Hospital | Ridgewood | New Jersey | 07450 | United States |
| Mt. Sinai School of Medicine | New York | New York | 10029 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| University of Oklahoma | Oklahoma City | Oklahoma | 73104 | United States |
| University of Pennslyvania | Philadelphia | Pennsylvania | 19104 | United States |
| Texas Cardiac Arrhythmia Foundation | Austin | Texas | 78705 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23219 | United States |
| Safety Cohort | Safety population includes those enrolled subjects who underwent insertion of the study catheter. |
|
| Primary Effectiveness Cohort | Safety cohort subjects meeting eligibility criteria & receiving radiofrequency (RF) ablation for AF |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All subjects who signed informed consent.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | THERMOCOOL® SMARTTOUCH™ Catheter | THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | All subjects who signed informed consent. | Count of Participants | Participants |
| |||||||||||||||||
| Ethnicity (NIH/OMB) | All subjects who signed informed consent. | Count of Participants | Participants |
| |||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects Achieved Freedom From Atrial Tachyarrhythmias | Freedom from documented symptomatic atrial fibrillation/atrial tachycardia/atrial flutter (hereinafter collectively referred to as "atrial tachyarrhythmias") based on electrocardiographic data during the effectiveness evaluation period (Day 91-361). Acute procedure failures, antiarrhythmic drug(AAD) changes and repeat ablation occurring during evaluation period were deemed as primary effectiveness failures | 137 Study-eligible subjects with per-protocol procedure. CENSORED: 1 lost to follow-up subject without recurrence | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 91-361 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Peri-procedural Serious Adverse Events | Peri-procedural serious adverse events (SAEs) are those non-primary SAEs occurred within 8-30 days post procedure | Safety cohort, including Enrolled subjects who underwent insertion of the study catheter. | Posted | Number | Number of participants | Within 8-30 days post procedure |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Incidence of Primary Adverse Events Within Specified Study Period | Primary safety endpoint consists of primary adverse events (AE) within 7 days post procedure Or pulmonary vein stenosis and atrio-esophageal fistula events that occurred within 12 months post-procedure. Primary adverse events include death, myocardial infarction, pulmonary vein stenosis, diaphragmatic paralysis, atrio-esophageal fistula, transient ischemic attack, stroke / cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade, pericardial effusion, pneumothorax, atrial perforation, vascular access complications, pulmonary edema, initial and prolonged hospitalization (excluding those due to pre-existing arrhythmia recurrence), heart block. | 144 subjects that had study catheter inserted into their body; INCLUDES study ineligible & untreated subjects | Posted | Number | 95% Confidence Interval | percentage of subjects with primary AE | 12 months post procedure |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Achieved Acute Effectiveness | Acute effectivenesss is defined as confirmation of entrance block into all Pulmonary veins | Effectiveness cohort, defined as those enrolled subjects who underwent insertion of the study catheter and an AF ablation procedure. Subjects without RF energy delivery will be excluded (i.e. discontinued subjects). | Posted | Number | 95% Confidence Interval | Percentage of participants | 5 hours of procedure time |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Late Onset Serious Adverse Events | Late onset serious adverse events (SAEs) are those non-primary SAEs occurred after 31 days post procedure | Safety cohort, including Enrolled subjects who underwent insertion of the study catheter. | Posted | Number | Number of participants | From 31 days post procedure to month 12 |
|
|
12 months post procedure
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | THERMOCOOL® SMARTTOUCH™ Catheter | THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation | 46 | 144 | 40 | 144 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment | Subjects experienced this serious adervse event required in-patient hospitalization or prolongation of existing hospitalization |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (12.0) | Systematic Assessment | Subjects experienced this serious adverse event required in-patient hospitalization or prolongation of existing hospitalization |
|
| Atrial flutter | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Chest pain | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dyspnoea | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Mitral valve disease | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pulmonary oedema | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Abdominal abscess | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Appendicitis | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Oesophageal rupture | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hip arthroplasty | Surgical and medical procedures | MedDRA (12.0) | Systematic Assessment |
| |
| Arteriovenous fistula | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fluid overload | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Oedema peripheral | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Syncope | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Arteriovenous fistula | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Chest pain | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
There IS an agreement between the Principal Investigator (PI)/Institution and the Sponsor (or its agents) that restricts the PI's rights to discuss, present or publish trial results after the trial is completed. Please contact Biosense Webster, Inc. for additional information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Stagg, PhD, Manager, Clinical Franchise | Biosense Webster, Inc. | (949) 450-7779 | rstagg@its.jnj.com |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Female |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Number of subjects had peri-procedural SAEs |
| |||||
| Possibly procedure related |
| |||||
| Not-related to procedure or device |
|
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Number of subjects had late onset SAEs |
| |||||
| Procedure related |
| |||||
| Not-related to procedure or device |
|