Paroxysmal Atrial FibrillationNCT01997736
Pilot Study Evaluating the Toray Satake Balloon Thermal Ablation System for Treatment of Paroxysmal Atrial Fibrillation
A study testing Ablation in people with Paroxysmal Atrial Fibrillation, run by Toray Industries (America), Inc. at 4 sites in United States.
Trial summary
The purpose of this study is to collect preliminary safety and effectiveness data evaluating the Toray Satake Balloon Thermal Ablation System (TSB)to treat subjects with symptomatic paroxysmal atrial fibrillation that is resistant to antiarrhythmic drug therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 4 sitesUnited States
- Study dates
- 22 Nov 2013to 1 Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Diagnosis of recurrent symptomatic paroxysmal atrial fibrillation
- ≥2 Symptomatic atrial fibrillation episodes
- At least 1 paroxysmal atrial fibrillation episode documented by an ECG or device recording system in the 6 months prior to enrollment AND
- At least 1 additional (for a total of ≥2) paroxysmal atrial fibrillation episode documented by an ECG or device recording system, OR, at a minimum, a physician's note indicating recurrent symptomatic atrial fibrillation
- No episode >7 days
- Failed to respond to or is intolerant of ≥1 Class I, II, III or IV antiarrhythmic drug
- Able and willing to provide informed consent and Health Insurance Privacy and Portability Act (HIPAA) authorization
- Able and willing to meet all study requirements, including attending all post-ablation procedure assessments and visits
Who cannot join
- Left atrium ≥50 mm
- Chronically used amiodarone in the 3 months prior to enrollment
- Previous left atrial ablation or surgical treatment for atrial fibrillation
- Left ventricular ejection fraction (LVEF) <35 %
- New York Heart Association (NYHA) Class III or IV heart failure
- History of myocardial infarction (MI) or unstable angina in the 6 months prior to enrollment
- Multiple other exclusion criteria to establish overall good health and likely study compliance
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
Mount Sinai Hospital
New York, New York, 10029
William Beaumont Hospital, Royal Oak
Royal Oak, Michigan, 48073
About this study
Official title: A Pilot Study Evaluating the Safety and Effectiveness of the Toray Satake Balloon Thermal Ablation System for the Treatment of Paroxysmal Atrial Fibrillation
The purpose of this study is to collect preliminary safety and effectiveness data evaluating the Toray Satake Balloon Thermal Ablation System (TSB)to treat subjects with symptomatic paroxysmal atrial fibrillation that is resistant to antiarrhythmic drug therapy.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- Ablation
- Keywords
- Paroxysmal Atrial Fibrillation, Catheter Ablation, Ablation Techniques
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AblationDevice
Also called Toray Satake Balloon Thermal Ablation System
| Study group | Role | What they receive |
|---|---|---|
| Ablation | Experimental | Not described Receives: Device: Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of major complications
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study start22 Nov 2013
- Primary completion15 Sep 2015
- Study completion1 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toray Industries (America), Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Haines, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997736
- Sponsor's protocol ID
- Toray America 2013-001
- Status last verified
- Apr 2018
- First submitted
- 8 Nov 2013
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Satake S, Tanaka K, Saito S, Tanaka S, Sohara H, Hiroe Y, Miyashita Y, Takahashi S, Murakami M, Watanabe Y. Usefulness of a new radiofrequency thermal balloon catheter for pulmonary vein isolation: a new device for treatment of atrial fibrillation. J Cardiovasc Electrophysiol. 2003 Jun;14(6):609-15. doi: 10.1046/j.1540-8167.2003.02577.x.
PubMed 12875422Sohara H, Satake S, Tanaka K, et al. Modification of electrophysiological properties of pulmonary veins and adjacent left atrial tissue by radiofrequency thermal balloon circumferential ablation around the pulmonary vein ostia: correlation with non-recurrence of atrial fibrillation. Journal of Arrhythmia 21(3):384-397, 2005.
Sohara H, Takeda H, Ueno H, Oda T, Satake S. Feasibility of the radiofrequency hot balloon catheter for isolation of the posterior left atrium and pulmonary veins for the treatment of atrial fibrillation. Circ Arrhythm Electrophysiol. 2009 Jun;2(3):225-32. doi: 10.1161/CIRCEP.108.817205. Epub 2009 Apr 2.
PubMed 19808472Sohara H, Satake S, Takeda H, et al. Radiofrequency hot balloon catheter ablation for the treatment of atrial fibrillation: a 3-center study in Japan. Journal of Arrhythmia 29:20-27, 2013
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating the Safety and Effectiveness of the Toray Satake Balloon Thermal Ablation System for the Treatment of Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01997736
- Acronym / sponsor ID
- Toray America 2013-001
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- Paroxysmal Atrial Fibrillation, Catheter Ablation, Ablation Techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Toray Industries (America), Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Nov 2013 (actual)
- Primary completion
- 15 Sep 2015 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 28 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to collect preliminary safety and effectiveness data evaluating the Toray Satake Balloon Thermal Ablation System (TSB)to treat subjects with symptomatic paroxysmal atrial fibrillation that is resistant to antiarrhythmic drug therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ablation | Experimental | Device: Ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of recurrent symptomatic paroxysmal atrial fibrillation
- ≥2 Symptomatic atrial fibrillation episodes
- At least 1 paroxysmal atrial fibrillation episode documented by an ECG or device recording system in the 6 months prior to enrollment AND
- At least 1 additional (for a total of ≥2) paroxysmal atrial fibrillation episode documented by an ECG or device recording system, OR, at a minimum, a physician's note indicating recurrent symptomatic atrial fibrillation
- No episode >7 days
Key exclusion criteria (7 listed)
- Left atrium ≥50 mm
- Chronically used amiodarone in the 3 months prior to enrollment
- Previous left atrial ablation or surgical treatment for atrial fibrillation
- Left ventricular ejection fraction (LVEF) <35 %
- New York Heart Association (NYHA) Class III or IV heart failure
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 |
|---|---|---|
| AblationAlso: Toray Satake Balloon Thermal Ablation System | Device | Ablation |
Primary outcome
Occurrence of major complications
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Background: PubMed 12875422Satake S, Tanaka K, Saito S, Tanaka S, Sohara H, Hiroe Y, Miyashita Y, Takahashi S, Murakami M, Watanabe Y. Usefulness of a new radiofrequency thermal balloon catheter for pulmonary vein isolation: a new device for treatment of atrial fibrillation. J Cardiovasc Electrophysiol. 2003 Jun;14(6):609-15. doi: 10.1046/j.1540-8167.2003.02577.x.
- BackgroundSohara H, Satake S, Tanaka K, et al. Modification of electrophysiological properties of pulmonary veins and adjacent left atrial tissue by radiofrequency thermal balloon circumferential ablation around the pulmonary vein ostia: correlation with non-recurrence of atrial fibrillation. Journal of Arrhythmia 21(3):384-397, 2005.
- Background: PubMed 19808472Sohara H, Takeda H, Ueno H, Oda T, Satake S. Feasibility of the radiofrequency hot balloon catheter for isolation of the posterior left atrium and pulmonary veins for the treatment of atrial fibrillation. Circ Arrhythm Electrophysiol. 2009 Jun;2(3):225-32. doi: 10.1161/CIRCEP.108.817205. Epub 2009 Apr 2.
- BackgroundSohara H, Satake S, Takeda H, et al. Radiofrequency hot balloon catheter ablation for the treatment of atrial fibrillation: a 3-center study in Japan. Journal of Arrhythmia 29:20-27, 2013
- Individual participant dataSharing planned: No
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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.
David Haines, MD principal investigator
Corewell Health East
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation in people with Paroxysmal Atrial Fibrillation, run by Toray Industries (America), Inc. at 4 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 8 inclusion and 7 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 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurrence of major complications (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01997736, which also lists 4 linked publications.
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 6 Sep 2019.