Atrial FibrillationPhase 3NCT02359890

SMART-SF Radiofrequency Ablation Safety Study

A Phase 3 study testing THERMOCOOL® SMARTTOUCH® (RF ablation treatment) 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.

Official record

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Trial 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). 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® (RF ablation treatment)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 165 participants
Where: No sites listed yet
Study dates: 1 Mar 2015to 8 Nov 2016
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

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

Who cannot join

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

Show all 28Show fewer

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

About this study

Official title: Prospective Safety Assessment of the THERMOCOOL® SMARTTOUCH® SF Family of Contact Force Sensing Catheters for the Radiofrequency Ablation Treatment of Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation

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).

Read the 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.

Conditions: Atrial Fibrillation
Being tested: THERMOCOOL® SMARTTOUCH® (RF ablation treatment)
Keywords: Interventional, Radiofrequency ablation, Paroxysmal Atrial Fibrillation
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® (RF ablation treatment)Device
Also called Pulmonary vein isolation
Radiofrequency Ablation Treatment

Study groups in NCT02359890
Study group	Role	What they receive
Treatment Group	Experimental	Pulmonary vein isolation by RF ablation treatment with the THERMOCOOL® SMARTTOUCH® SF family of contact force sensing catheters (study device) Receives: Device: THERMOCOOL® SMARTTOUCH® (RF ablation treatment)

What is being measured

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

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.
Measured: Seven days post ablation procedure

Secondary outcomes (3)

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
Measured: Up to 30 days post Procedure
Percentage of Participants With Acute Success
Acute success is defined as confirmation of entrance block in all Pulmonary veins (PV).
Measured: End of procedure
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
Measured: 12 months

Timeline

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

1 Mar 20158 Nov 2016

First posted10 Feb 2015 (estimated)
Study start1 Mar 2015
Primary completion1 Sep 2015
Study completion8 Nov 2016

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.
Publications (2)Papers the sponsor has linked to this study.
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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 165 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02359890
Sponsor's protocol ID: SMART-SF
Other IDs: STSF-162
Status last verified: Jan 2025
First submitted: 3 Feb 2015
Last updated: 4 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Natale A, Reddy VY, Monir G, Wilber DJ, Lindsay BD, McElderry HT, Kantipudi C, Mansour MC, Melby DP, Packer DL, Nakagawa H, Zhang B, Stagg RB, Boo LM, Marchlinski FE. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. J Am Coll Cardiol. 2014 Aug 19;64(7):647-56. doi: 10.1016/j.jacc.2014.04.072.
PubMed 25125294
Oza SR, Hunter TD, Biviano AB, Dandamudi G, Herweg B, Patel AM, Pollak SJ, Wang H, Fishel RS. Acute safety of an open-irrigated ablation catheter with 56-hole porous tip for radiofrequency ablation of paroxysmal atrial fibrillation: analysis from 2 observational registry studies. J Cardiovasc Electrophysiol. 2014 Aug;25(8):852-858. doi: 10.1111/jce.12403. Epub 2014 Apr 9.
PubMed 24602038

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

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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: Prospective Safety Assessment of the THERMOCOOL® SMARTTOUCH® SF Family of Contact Force Sensing Catheters for the Radiofrequency Ablation Treatment of Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation
ClinicalTrials.gov ID: NCT02359890
Acronym / sponsor ID: SMART-SF
Conditions: Atrial Fibrillation
Keywords: Interventional, Radiofrequency ablation, Paroxysmal Atrial Fibrillation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 165 participants (actual)
Lead sponsor: Biosense Webster, Inc.Industry (pharma, biotech, devices)
Study start: 1 Mar 2015 (actual)
Primary completion: 1 Sep 2015 (actual)
Study completion: 8 Nov 2016 (actual)
First posted: 10 Feb 2015 (estimated)
Results: Posted 17 Oct 2017

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 safety assessment of the study device during radiofrequency (RF) ablation treatment of patients with drug refractory symptomatic atrial fibrillation (SMART-SF).

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® (RF ablation treatment)Pulmonary vein isolation by RF ablation treatment with the THERMOCOOL® SMARTTOUCH® SF family of contact force sensing catheters (study device)

Who may qualify

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

Key inclusion criteria (3 listed)

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

Key exclusion criteria (28 listed)

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

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® (RF ablation treatment)Also: Pulmonary vein isolationRadiofrequency Ablation Treatment	Device	Treatment Group

Primary outcome

Percentage of Participants With Early Onset Primary Adverse Events
Time frame: 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.

3 secondary outcomes

Percentage of Participants With Non-Primary Serious Adverse Events (SAEs)
Time frame: Up to 30 days post Procedure
Percentage of Participants With Acute Success
Time frame: End of procedure
Effectiveness Endpoint: Freedom From Documented Atrial Fibrillation (AF)/Atrial Tachycardia (AT)/Atrial Flutter (AFL)
Time frame: 12 months

Results and safety

Results posted to the registry on 17 Oct 2017, 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® SF Family of Catheters	165	155

Primary outcome: Percentage of Participants With Early Onset Primary Adverse Events

Time frame: Seven days post ablation procedure. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	THERMOCOOL SMARTTOUCH® SF Catheters n = 155
Value	2.6 (0.7 to 6.5)

THERMOCOOL SMARTTOUCH® SF Catheters: Percentage of participants with events: 2.6 (95% CI 0.7 to 6.5)

Population analysed: 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.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 days post procedure. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
THERMOCOOL SMARTTOUCH® SF Family of Catheters	9 of 159 (5.7%)	31 of 159 (19.5%)	Not reported

Limitations and caveats (from the sponsor): Additional data pertaining to this study expected to be submitted in August 2018. Re-monitoring of safety event data is in progress.

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.
Background: PubMed 25125294Natale A, Reddy VY, Monir G, Wilber DJ, Lindsay BD, McElderry HT, Kantipudi C, Mansour MC, Melby DP, Packer DL, Nakagawa H, Zhang B, Stagg RB, Boo LM, Marchlinski FE. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. J Am Coll Cardiol. 2014 Aug 19;64(7):647-56. doi: 10.1016/j.jacc.2014.04.072.
Background: PubMed 24602038Oza SR, Hunter TD, Biviano AB, Dandamudi G, Herweg B, Patel AM, Pollak SJ, Wang H, Fishel RS. Acute safety of an open-irrigated ablation catheter with 56-hole porous tip for radiofrequency ablation of paroxysmal atrial fibrillation: analysis from 2 observational registry studies. J Cardiovasc Electrophysiol. 2014 Aug;25(8):852-858. doi: 10.1111/jce.12403. Epub 2014 Apr 9.
Sponsor websiteLink provided by the sponsor.

Related trials for Atrial Fibrillation

Active, not recruiting
ARIADNE Clinical Trial
Persistent Atrial Fibrillation
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 recruitingPhase 4
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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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing THERMOCOOL® SMARTTOUCH® (RF ablation treatment) 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 3 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 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 17 Oct 2017). 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 Participants With Early Onset Primary Adverse Events (time frame: Seven days post ablation procedure). 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 NCT02359890, which also lists 2 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 4 Feb 2025.