SMART China, A Multi-center Clinical Registry Study

A Phase 4 study testing THERMOCOOL® SMARTTOUCH™ in people with Atrial Fibrillation, run by Biosense Webster, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrial Fibrillation
What is being tested?: THERMOCOOL® SMARTTOUCH™
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: No sites listed yet
Study dates: 1 Jul 2015to 30 Jun 2017
Phase: Phase 4
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

Age 18 years or older
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
Patients with paroxysmal AF eligible for catheter ablation
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)
Able and willing to comply with all pre-, post- and follow-up testing and requirements
Be able to sign IRB/EC-approved informed consent form

Who cannot join

AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
Previous surgical or catheter ablation for AF
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.
Any carotid stenting or endarterectomy.
Coronary artery bypass graft (CABG) procedure within the last 180 days (6 months)
AF episodes lasting longer than 7 days or terminated via cardioversion

Show all 28Show fewer

Documented left atrial thrombus on imaging
Uncontrolled heart Failure or New York Heart Association (NYHA) class III or IV
Myocardial Infarction within the previous 60 days (2 months)
Documented thromboembolic event (including TIA) within the past 12 months
Rheumatic heart disease
Awaiting cardiac transplantation or other cardiac surgery within the next 365 days (12 months)
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.
Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
Active illness or active systemic infection or sepsis
Diagnosed atrial myxoma
Unstable angina within the past 60 days (2 months)
History of blood clotting or bleeding abnormalities
Life expectancy less than 365 days (12 months)
Hypertrophic obstructive cardiomyopathy
Presence of implanted ICD
Contraindication to anticoagulation
Contraindication to isoproterenol
Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation
Women who are pregnant and/or breast feeding
Presence of a condition that precludes vascular access.
Patients presenting contraindications for study catheter(s), as indicated in the respective Instructions For Use
Enrollment in an investigational study evaluating another device, biologic, or drug.

About this study

Official title: The Effectiveness and Safety in the Treatment of Circumferential Pulmonary Vein Isolation (CPVI) for Symptomatic Paroxysmal Atrial Fibrillation With THERMOCOOL® SMARTTOUCH™ Catheter in China, A Multi-center Clinical Registry Study

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.

Read the 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.

Conditions: Atrial Fibrillation
Being tested: THERMOCOOL® SMARTTOUCH™
Keywords: Interventional, Radiofrequency ablation, Paroxysmal Atrial Fibrillation, Catheter ablation
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™Device
Also called Pulmonary vein isolation
Pulmonary vein isolation by RF ablation treatment with the THERMOCOOL® SMARTTOUCH™ contact force sensing catheters (study device)

Study groups in NCT02485925
Study group	Role	What they receive
Treatment group	Experimental	THERMOCOOL® SMARTTOUCH™ Receives: Device: THERMOCOOL® SMARTTOUCH™

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 12 Months

Secondary outcomes (4)

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.
Measured: 0.5 hours
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
Measured: 1 day during procedure
Percent of Subjects With Pulmonary Vein Reconnection for the Index Procedure
Percentage of subjects with PV reconnection after the first ablation
Measured: 1 day during procedure
Procedure Time, Ablation Time and Fluoroscopy Time
Procedure Time, Ablation Time and Fluoroscopy Time in minutes
Measured: 1 day during procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 201530 Jun 2017

First posted30 Jun 2015 (estimated)
Study start1 Jul 2015
Primary completion30 Jun 2017
Study completion30 Jun 2017

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 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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02485925
Sponsor's protocol ID: BW-201501
Status last verified: Jan 2025
First submitted: 25 Jun 2015
Last updated: 4 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
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AI-Based Cardiac Analysis Using 12-Lead and 1-Lead ECG
Heart Failure, Atrial Fibrillation (AF)
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Not yet recruiting
CATCH AF - Atrial Fibrillation Detection in Cryptogenic Stroke
Atrial Fibrillation (AF)
Active, not recruiting
ARIADNE Clinical Trial
Persistent Atrial Fibrillation

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effectiveness and Safety in the Treatment of Circumferential Pulmonary Vein Isolation (CPVI) for Symptomatic Paroxysmal Atrial Fibrillation With THERMOCOOL® SMARTTOUCH™ Catheter in China, A Multi-center Clinical Registry Study
ClinicalTrials.gov ID: NCT02485925
Acronym / sponsor ID: BW-201501
Conditions: Atrial Fibrillation
Keywords: Interventional, Radiofrequency ablation, Paroxysmal Atrial Fibrillation, Catheter ablation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Biosense Webster, Inc.Industry (pharma, biotech, devices)
Study start: 1 Jul 2015 (actual)
Primary completion: 30 Jun 2017 (actual)
Study completion: 30 Jun 2017 (actual)
First posted: 30 Jun 2015 (estimated)
Results: Posted 31 Jul 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 effectiveness and safety assessment of the study device during radiofrequency (RF) ablation treatment of patients with drug refractory symptomatic atrial fibrillation.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment group	Experimental	Device: THERMOCOOL® SMARTTOUCH™THERMOCOOL® SMARTTOUCH™

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Age 18 years or older
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
Patients with paroxysmal AF eligible for catheter ablation
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)
Able and willing to comply with all pre-, post- and follow-up testing and requirements

Key exclusion criteria (28 listed)

AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
Previous surgical or catheter ablation for AF
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.
Any carotid stenting or endarterectomy.
Coronary artery bypass graft (CABG) procedure within the last 180 days (6 months)

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™Also: Pulmonary vein isolationPulmonary vein isolation by RF ablation treatment with the THERMOCOOL® SMARTTOUCH™ contact force sensing catheters (study device)	Device	Treatment group

Primary outcome

Percentage of Patients With Freedom From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes
Time frame: 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).

4 secondary outcomes

Percentage of Patients Where Acute Success Was Achieved
Time frame: 0.5 hours
Average Contact Force Per Pulmonary Vein Ablation Procedure
Time frame: 1 day during procedure
Percent of Subjects With Pulmonary Vein Reconnection for the Index Procedure
Time frame: 1 day during procedure
Procedure Time, Ablation Time and Fluoroscopy Time
Time frame: 1 day during procedure

Results and safety

Results posted to the registry on 31 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
THERMOCOOL® SMARTTOUCH™ Family of Catheters	200	185

Primary outcome: Percentage of Patients With Freedom From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes

Time frame: 12 Months. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	THERMOCOOL® SMARTTOUCH™ Family of Catheters n = 166
Value	80.7 (73.9 to 86.4)

THERMOCOOL® SMARTTOUCH™ Family of Catheters: Proportion of participants: 80.7 (95% CI 73.9 to 86.4)

Population analysed: 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.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months after ablation procedure. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
THERMOCOOL® SMARTTOUCH™ Family of Catheters	26 of 200 (13%)	28 of 200 (14%)	1 of 200

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Sponsor websiteLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

Related trials for Atrial Fibrillation

Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
RecruitingObservational study
AI-Based Cardiac Analysis Using 12-Lead and 1-Lead ECG
Heart Failure, Atrial Fibrillation (AF)
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Not yet recruiting
CATCH AF - Atrial Fibrillation Detection in Cryptogenic Stroke
Atrial Fibrillation (AF)
Active, not recruiting
ARIADNE Clinical Trial
Persistent Atrial Fibrillation

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.

Congxin Huang principal investigator

Renmin Hospital of Wuhan University

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing THERMOCOOL® SMARTTOUCH™ in people with Atrial Fibrillation, run by Biosense Webster, Inc..

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 6 inclusion and 28 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 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 31 Jul 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 Patients With Freedom From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes (time frame: 12 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 NCT02485925.

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 4 Feb 2025.