Heart DiseasesPhase 3NCT01385202

THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation

A Phase 3 study testing THERMOCOOL® SMARTTOUCH™ Catheter in people with Heart Diseases and Arrhythmia, 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

The purpose of this study is to demonstrate the safety and effectiveness of the THERMOCOOL® SMARTTOUCH™ Catheters with Contact Force Sensing Capability in the treatment of drug refractory symptomatic paroxysmal Atrial Fibrillation (AF) during standard electrophysiology mapping and RF procedures. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Diseases, Arrhythmia, 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: 172 participants
Where: No sites listed yet
Study dates: Jun 2011to May 2013
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

About this study

Conditions: Heart Diseases, Arrhythmia, Atrial Fibrillation
Being tested: THERMOCOOL® SMARTTOUCH™ Catheter
Keywords: Atrial Fibrillation, Paroxysmal Atrial Fibrillation
Medical subject headings: Heart Diseases, Arrhythmias, Cardiac, 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 groups in NCT01385202
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.

The Rate of Subjects Who Were Free From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 12-month Follow-up
The primary effectiveness endpoint for this study will be freedom from documented symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 12-month follow-up (includes a three month blanking period).
Measured: 12-months
Incidence of Early Onset (Within 7 Days of the AF Ablation Procedure) Primary Adverse Events.
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, Pericardial effusion, Pneumothorax, Atrial perforation, Vascular Access Complications, Pulmonary edema, Hospitalization (initial and prolonged), and Heart block.
Measured: 7 days of the AF ablation procedure

Secondary outcomes (1)

Rate of Acute Success
Acute success is defined as confirmation of entrance block in all Pulmonary veins (PV).
Measured: End of procedure

Timeline

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

Jun 2011May 2013

First posted30 Jun 2011 (estimated)
Study startJun 2011
Primary completionFeb 2013
Study completionMay 2013

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 Heart DiseasesStudies 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
Masking: None (open label)
Enrolment: 172 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01385202
Sponsor's protocol ID: Smart-AF
Status last verified: Jan 2025
First submitted: 27 Jun 2011
Last updated: 4 Feb 2025
Results posted: Yes, on ClinicalTrials.gov

Publications

Reddy VY, Pollak S, Lindsay BD, McElderry HT, Natale A, Kantipudi C, Mansour M, Melby DP, Lakkireddy D, Levy T, Izraeli D, Sangli C, Wilber D. Relationship Between Catheter Stability and 12-Month Success After Pulmonary Vein Isolation: A Subanalysis of the SMART-AF Trial. JACC Clin Electrophysiol. 2016 Nov;2(6):691-699. doi: 10.1016/j.jacep.2016.07.014. Epub 2016 Nov 21.
PubMed 29759747
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

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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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: THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
ClinicalTrials.gov ID: NCT01385202
Acronym / sponsor ID: Smart-AF
Conditions: Heart Diseases, Arrhythmia, Atrial Fibrillation
Keywords: Atrial Fibrillation, Paroxysmal Atrial Fibrillation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 172 participants (actual)
Lead sponsor: Biosense Webster, Inc.Industry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Feb 2013 (actual)
Study completion: May 2013 (actual)
First posted: 30 Jun 2011 (estimated)
Results: Posted 26 Jan 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

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

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

The Rate of Subjects Who Were Free From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 12-month Follow-up
Time frame: 12-months
The primary effectiveness endpoint for this study will be freedom from documented symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 12-month follow-up (includes a three month blanking period).
Incidence of Early Onset (Within 7 Days of the AF Ablation Procedure) Primary Adverse Events.
Time frame: 7 days of the 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, Pericardial effusion, Pneumothorax, Atrial perforation, Vascular Access Complications, Pulmonary edema, Hospitalization (initial and prolonged), and Heart block.

1 secondary outcome

Rate of Acute Success
Time frame: End of procedure

Results and safety

Results posted to the registry on 26 Jan 2015, 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™ Catheter	172	154

Primary outcome: The Rate of Subjects Who Were Free From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 12-month Follow-up

Time frame: 12-months. Number (95% Confidence Interval). Unit: percentage of participants

Measure	THERMOCOOL® SMARTTOUCH™ Catheter n = 114
Value	70.2 (60.9 to 78.4)

THERMOCOOL® SMARTTOUCH™ Catheter: Primary effectiveness rate: 70.2 (95% CI 60.9 to 78.4), p <0.0001, Fisher Exact
THERMOCOOL® SMARTTOUCH™ Catheter: Primary effectiveness rate: 74 (95% CI 66 to 82)

Population analysed: Primary Effectiveness Cohort includes those enrolled who met the inclusion/exclusion criteria and had undergone insertion of the study catheter and Atrial Fibrillation (AF) ablation procedure, excluding those with radiofrequency energy not delivered, with calibration roll-in, and with only non-study arrhythmia.

Primary outcome: Incidence of Early Onset (Within 7 Days of the AF Ablation Procedure) Primary Adverse Events.

Time frame: 7 days of the AF ablation procedure. Number (95% Confidence Interval). Unit: Percentage of patients with primary AE

Measure	THERMOCOOL® SMARTTOUCH™ Catheter n = 161
Value	9.9 (5.8 to 15.6)

Population analysed: Safety cohort includes all enrolled subjects who had the study catheter inserted.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
THERMOCOOL® SMARTTOUCH™ Catheter	38 of 161 (23.6%)	70 of 161 (43.5%)	Not reported

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.
Derived from this study: PubMed 29759747Reddy VY, Pollak S, Lindsay BD, McElderry HT, Natale A, Kantipudi C, Mansour M, Melby DP, Lakkireddy D, Levy T, Izraeli D, Sangli C, Wilber D. Relationship Between Catheter Stability and 12-Month Success After Pulmonary Vein Isolation: A Subanalysis of the SMART-AF Trial. JACC Clin Electrophysiol. 2016 Nov;2(6):691-699. doi: 10.1016/j.jacep.2016.07.014. Epub 2016 Nov 21.
Derived from this study: 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.

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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.

Andrea Natale, MD study chair

Texas Cardiac Arrhythmia Research

David J Wilber, MD study chair

Loyola University

Francis E Marchlinski, MD study chair

University of Pennsylvania

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing THERMOCOOL® SMARTTOUCH™ Catheter in people with Heart Diseases and Arrhythmia, 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 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 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 26 Jan 2015). 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?

The Rate of Subjects Who Were Free From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 12-month Follow-up (time frame: 12-months). 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?

On the ClinicalTrials.gov record for NCT01385202, 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.