Drug Refractory Symptomatic Paroxysmal Atrial FibrillationPhase 3NCT01639495
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation CONTINUED ACCESS
A Phase 3 study testing THERMOCOOL® SMARTTOUCH™ Catheter in people with Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation, run by Biosense Webster, Inc. at 20 sites in United States.
Trial summary
This is a prospective, multicenter, non-randomized continued access clinical evaluation utilizing the THERMOCOOL® SMARTTOUCH™ catheter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation
- What is being tested?
- THERMOCOOL® SMARTTOUCH™ Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 20 sitesUnited States
- Study dates
- 1 Jul 2012to 1 Oct 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have had at least 3 atrial fibrillation episodes within 6 months of this study
- Have failed at least one antiarrhythmic drug shown by repeated atrial fibrillation episodes
- 18 years of age or older
Who cannot join
- Have had previous ablation for atrial fibrillation
- Have take amiodarone within 6 months of this study
- Have had any heart surgery within the last 60 days
- Have had a heart attack within the last 60 days
- Females who are pregnant or breast feeding
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Piedmont Heart Institute
Atlanta, Georgia, 30309
Texas Cardiac Arrhythmia Foundation
Austin, Texas, 78705
Johns Hopkins Hospital
Baltimore, Maryland, 21287
University of Alabama, Birmingham
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio State University
Columbus, Ohio, 43210
Duke University Medical Center
Durham, North Carolina, 27710
University of Kansas Hospitals
Kansas City, Kansas, 66160
Loyola University Chicago
Maywood, Illinois, 60153
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Mt. Sinai School of Medicine
New York, New York, 10029
University of Oklahoma
Oklahoma City, Oklahoma, 73104
Florida Hospital
Orlando, Florida, 32803
University of Pennslyvania
Philadelphia, Pennsylvania, 19104
Virginia Commonwealth University
Richmond, Virginia, 23219
The Valley Hospital
Ridgewood, New Jersey, 07450
Mayo Clinic
Rochester, Minnesota, 55902
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation Continued Access
This is a prospective, multicenter, non-randomized continued access clinical evaluation utilizing the THERMOCOOL® SMARTTOUCH™ catheter.
Read the detailed description
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.
- Being tested
- THERMOCOOL® SMARTTOUCH™ Catheter
- Keywords
- Drug refractory, Atrial fibrillation, Antiarrhythmic drug failure, Atrial tachyarrhythmias
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THERMOCOOL® SMARTTOUCH™ CatheterDevice
AF Ablation
| Study group | Role | What they receive |
|---|---|---|
| THERMOCOOL® SMARTTOUCH™ Catheter | Experimental | Not described Receives: Device: THERMOCOOL® SMARTTOUCH™ Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 12 months post procedure
Secondary outcomes (3)
Peri-procedural Serious Adverse Events
Peri-procedural serious adverse events (SAEs) are those non-primary SAEs occurred within 8-30 days post procedure
Measured: Within 8-30 days post procedure
Percentage of Subjects Achieved Acute Effectiveness
Acute effectivenesss is defined as confirmation of entrance block into all Pulmonary veins
Measured: 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
Measured: From 31 days post procedure to month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study start1 Jul 2012
- Primary completion1 Jun 2014
- Study completion1 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Drug Refractory Symptomatic Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Biosense Webster, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study had a single arm: catheter ablation for PAF
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosense Webster, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639495
- Sponsor's protocol ID
- SMART-AF CA
- Status last verified
- Apr 2018
- First submitted
- 10 Jul 2012
- Last updated
- 15 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation Continued Access
- ClinicalTrials.gov ID
- NCT01639495
- Acronym / sponsor ID
- SMART-AF CA
- Keywords
- Drug refractory, Atrial fibrillation, Antiarrhythmic drug failure, Atrial tachyarrhythmias
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Biosense Webster, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2012 (actual)
- Primary completion
- 1 Jun 2014 (actual)
- Study completion
- 1 Oct 2014 (actual)
- First posted
- 12 Jul 2012 (estimated)
- Results
- Posted 15 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multicenter, non-randomized continued access clinical evaluation utilizing the THERMOCOOL® SMARTTOUCH™ catheter.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study had a single arm: catheter ablation for PAF
| Arm | Type | Receives |
|---|---|---|
| THERMOCOOL® SMARTTOUCH™ Catheter | Experimental | Device: THERMOCOOL® SMARTTOUCH™ Catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have had at least 3 atrial fibrillation episodes within 6 months of this study
- Have failed at least one antiarrhythmic drug shown by repeated atrial fibrillation episodes
- 18 years of age or older
Key exclusion criteria (5 listed)
- Have had previous ablation for atrial fibrillation
- Have take amiodarone within 6 months of this study
- Have had any heart surgery within the last 60 days
- Have had a heart attack within the last 60 days
- Females who are pregnant or breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THERMOCOOL® SMARTTOUCH™ CatheterAF Ablation | Device | THERMOCOOL® SMARTTOUCH™ Catheter |
Primary outcome
Percentage of Subjects Achieved Freedom From Atrial Tachyarrhythmias
Time frame: Day 91-361
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
Incidence of Primary Adverse Events Within Specified Study Period
Time frame: 12 months post procedure
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.
3 secondary outcomes
Peri-procedural Serious Adverse Events
Time frame: Within 8-30 days post procedure
Percentage of Subjects Achieved Acute Effectiveness
Time frame: 5 hours of procedure time
Late Onset Serious Adverse Events
Time frame: From 31 days post procedure to month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing THERMOCOOL® SMARTTOUCH™ Catheter in people with Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation, run by Biosense Webster, Inc. at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects Achieved Freedom From Atrial Tachyarrhythmias (time frame: Day 91-361). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2018.