Safety and Effectiveness of STSF Catheter Evaluated for Treating Symptomatic Persistent Atrial Fibrillation (PsAF)

A study testing THERMOCOOL SMARTTOUCH® SF catheter 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, multicenter, non-randomized clinical evaluation utilizing the THERMOCOOL SMARTTOUCH® SF catheter compared to a predetermined performance goal. 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® SF catheter
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 381 participants
Where: No sites listed yet
Study dates: 1 Jun 2016to 5 Jun 2019
Phase: Interventional
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

Candidates for this study must meet ALL of the following criteria:
Documented symptomatic persistent AF, which is defined as continuous AF sustains beyond 7 days and less than 1 year and is documented by the following:.
Physician's note indicating continuous AF ≥ 7 days but no more than 1 year; AND
Two electrocardiograms (from any forms of rhythm monitoring) showing continuous AF, with electrocardiogram taken at least 7 days apart OR
24-hour Holter within 90 days of the ablation procedure showing continuous AF
Failed at least one antiarrhythmic drug (AAD) (class I or III) as evidenced by recurrent symptomatic AF, or intolerable to the AAD.

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Age 18 years or older.
Signed Patient Informed Consent Form (ICF).
Able and willing to comply with all pre-, post-, and follow-up testing and requirements.

Who cannot join

Candidates for this study will be EXCLUDED from the study if ANY of the following conditions apply:
Continuous AF > 12 months (1-Year) (Longstanding Persistent AF)
Previous surgical or catheter ablation for atrial fibrillation
Any cardiac surgery within the past 2 months (60 days) (includes percutaneous coronary intervention (PCI))
Coronary Artery Bypass Graft (CABG) surgery within the past 6 months (180 days)
Valvular cardiac surgical/percutaneous procedure (i.e., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)

Show all 31Show fewer

Any carotid stenting or endarterectomy
Documented left atrial (LA) thrombus on imaging
LA size > 50 mm (parasternal long axis view)
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 (60 days)
Documented thromboembolic event (including Transient Ischemic Attack (TIA) within the past 12 months (365 days)
Rheumatic Heart Disease
Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV
Severe mitral regurgitation (Regurgitant volume ≥ 60 mL/beat, Regurgitant fraction ≥ 50%, and/or Effective regurgitant orifice area ≥ 0.40cm2)
Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)
Unstable angina
Acute illness or active systemic infection or sepsis
AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
Diagnosed atrial myxoma.
Presence of implanted implantable cardioverter defibrillator (ICD) /cardiac resynchronization therapy defibrillator (CRT-D).
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.
Gastroesophageal Reflux Disease (GERD; active requiring significant intervention not including over-the-counter (OTC) medication)
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 any other condition that precludes appropriate vascular access.
Life expectancy less than 12 months

About this study

Official title: Prospective Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH® SF (STSF) Catheter Evaluated for Treating Symptomatic PersistenT AF (PRECEPT)

This is a prospective, multicenter, non-randomized clinical evaluation utilizing the THERMOCOOL SMARTTOUCH® SF catheter compared to a predetermined performance goal.

Read the detailed description

The purpose of this study is to demonstrate the safety and effectiveness of the THERMOCOOL SMARTTOUCH® SF catheter in the treatment of drug refractory symptomatic persistent atrial fibrillation (PsAF) following standard electrophysiology mapping and radio frequency (RF) ablation procedures.

Conditions: Atrial Fibrillation
Being tested: THERMOCOOL SMARTTOUCH® SF catheter
Keywords: Interventional, Radiofrequency Ablation, Persistent 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® SF catheterDevice
Radiofrequency Ablation

Study groups in NCT02817776
Study group	Role	What they receive
Treatment group	Experimental	Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population. Receives: Device: THERMOCOOL SMARTTOUCH® SF catheter

What is being measured

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

Primary Safety Endpoint - Percentage of Participants With Any PAE Within 7 Days
The primary safety endpoint is the incidence of any early onset (within 7 days of the initial and repeat AF ablation procedure) Primary Adverse Events (AE), which are listed below:
- Death
- Atrio-esophageal fistula*
- Cardiac Tamponade**+/Perforation+
- Myocardial infarction (MI)
- Stroke / Cerebrovascular accident (CVA) †, ††
- Thromboembolism
- Transient Ischemic Attack
- Diaphragmatic paralysis
- Pneumothorax
- Heart block
- PV stenosis*
- Pulmonary edema (Respiratory Insufficiency)
- Pericarditis
- Major Vascular access complication / bleeding
Measured: 7 days (except as noted in analysis population description)
Effectiveness: Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 15-month Follow-up
The primary effectiveness endpoint for this study will be freedom from documented atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 15-month follow-up (post 3-Month Medication Adjustment Period followed by a 3-Month Therapy Consolidation period (Day 181-450)) and freedom from the following failure modes:
- Acute Procedural Failure
- Non-Study Catheter Failure
- Repeat Ablation Failure
- AAD Failure
- Surgical Failure
Measured: 15-month follow-up

Secondary outcomes (5)

Acute Procedural Success
Acute procedural success is defined as confirmation of entrance block in all pulmonary veins.
Measured: Immediate post-procedure
15-Month Single Procedure Success
The 15-month single procedure success is defined as freedom from documented AF/AFL/AT recurrence (episodes > 30 secs) during the Evaluation Period after a single ablation procedure. Any repeat ablation procedure during the Evaluation Period will be deemed effectiveness failure for this analysis.
Measured: 15-Month
Early Onset Serious Adverse Event (SAE)
Occurrence of Early Onset (within 7 days of initial ablation) Serious Adverse Event
Measured: 7 days
Peri-Procedural Serious Adverse Event (SAE)
Peri-Procedural (>7 to 30 days) Serious Adverse Event
Measured: >7 to 30 days
Late Onset Serious Adverse Event (SAE)
Occurrence of Late Onset (>30 days) Serious Adverse Event
Measured: >30 days up to 15 months

Timeline

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

1 Jun 20165 Jun 2019

First posted29 Jun 2016 (estimated)
Study start1 Jun 2016
Primary completion5 Jun 2019
Study completion5 Jun 2019

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.
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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 381 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02817776
Sponsor's protocol ID: STSF-159
Acronym: PRECEPT
Status last verified: Jan 2025
First submitted: 27 Jun 2016
Last updated: 4 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Natale A, Calkins H, Osorio J, Pollak SJ, Melby D, Marchlinski FE, Athill CA, Delaughter C, Patel AM, Gentlesk PJ, DeVille B, Macle L, Ellenbogen KA, Dukkipati SR, Reddy VY, Mansour M; PRECEPT Investigators. Positive Clinical Benefit on Patient Care, Quality of Life, and Symptoms After Contact Force-Guided Radiofrequency Ablation in Persistent Atrial Fibrillation: Analyses From the PRECEPT Prospective Multicenter Study. Circ Arrhythm Electrophysiol. 2021 Jan;14(1):e008867. doi: 10.1161/CIRCEP.120.008867. Epub 2020 Dec 8.
PubMed 33290093
Mansour M, Calkins H, Osorio J, Pollak SJ, Melby D, Marchlinski FE, Athill CA, Delaughter C, Patel AM, Gentlesk PJ, DeVille B, Macle L, Ellenbogen KA, Dukkipati SR, Reddy VY, Natale A. Persistent Atrial Fibrillation Ablation With Contact Force-Sensing Catheter: The Prospective Multicenter PRECEPT Trial. JACC Clin Electrophysiol. 2020 Aug;6(8):958-969. doi: 10.1016/j.jacep.2020.04.024.
PubMed 32819531

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
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

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 Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH® SF (STSF) Catheter Evaluated for Treating Symptomatic PersistenT AF (PRECEPT)
ClinicalTrials.gov ID: NCT02817776
Acronym / sponsor ID: PRECEPT / STSF-159
Conditions: Atrial Fibrillation
Keywords: Interventional, Radiofrequency Ablation, Persistent Atrial Fibrillation
Study type: Interventional
Recruitment status: Completed
Enrolment: 381 participants (actual)
Lead sponsor: Biosense Webster, Inc.Industry (pharma, biotech, devices)
Study start: 1 Jun 2016 (actual)
Primary completion: 5 Jun 2019 (actual)
Study completion: 5 Jun 2019 (actual)
First posted: 29 Jun 2016 (estimated)
Results: Posted 12 Jan 2021

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 clinical evaluation utilizing the THERMOCOOL SMARTTOUCH® SF catheter compared to a predetermined performance goal.

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® SF catheterPulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.

Who may qualify

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

Key inclusion criteria (9 listed)

Documented symptomatic persistent AF, which is defined as continuous AF sustains beyond 7 days and less than 1 year and is documented by the following:.
Failed at least one antiarrhythmic drug (AAD) (class I or III) as evidenced by recurrent symptomatic AF, or intolerable to the AAD.
Age 18 years or older.
Signed Patient Informed Consent Form (ICF).
Able and willing to comply with all pre-, post-, and follow-up testing and requirements.

Key exclusion criteria (31 listed)

Candidates for this study will be EXCLUDED from the study if ANY of the following conditions apply:
Continuous AF > 12 months (1-Year) (Longstanding Persistent AF)
Previous surgical or catheter ablation for atrial fibrillation
Any cardiac surgery within the past 2 months (60 days) (includes percutaneous coronary intervention (PCI))
Coronary Artery Bypass Graft (CABG) surgery within the past 6 months (180 days)

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® SF catheterRadiofrequency Ablation	Device	Treatment group

Primary outcome

Primary Safety Endpoint - Percentage of Participants With Any PAE Within 7 Days
Time frame: 7 days (except as noted in analysis population description)
The primary safety endpoint is the incidence of any early onset (within 7 days of the initial and repeat AF ablation procedure) Primary Adverse Events (AE), which are listed below: * Death * Atrio-esophageal fistula* * Cardiac Tamponade**+/Perforation+ * Myocardial infarction (MI) * Stroke / Cerebrovascular accident (CVA) †, †† * Thromboembolism * Transient Ischemic Attack * Diaphragmatic paralysis * Pneumothorax * Heart block * PV stenosis* * Pulmonary edema (Respiratory Insufficiency) * Pericarditis * Major Vascular access complication / bleeding
Effectiveness: Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 15-month Follow-up
Time frame: 15-month follow-up
The primary effectiveness endpoint for this study will be freedom from documented atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 15-month follow-up (post 3-Month Medication Adjustment Period followed by a 3-Month Therapy Consolidation period (Day 181-450)) and freedom from the following failure modes: * Acute Procedural Failure * Non-Study Catheter Failure * Repeat Ablation Failure * AAD Failure * Surgical Failure

5 secondary outcomes

Acute Procedural Success
Time frame: Immediate post-procedure
15-Month Single Procedure Success
Time frame: 15-Month
Early Onset Serious Adverse Event (SAE)
Time frame: 7 days
Peri-Procedural Serious Adverse Event (SAE)
Time frame: >7 to 30 days
Late Onset Serious Adverse Event (SAE)
Time frame: >30 days up to 15 months

Results and safety

Results posted to the registry on 12 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Group	381	293

Primary outcome: Primary Safety Endpoint - Percentage of Participants With Any PAE Within 7 Days

Time frame: 7 days (except as noted in analysis population description). Number. Unit: Percentage of participants

Measure	Treatment Group n = 344
Value	4.7

Population analysed: The safety population was used as the primary analysis population. Subjects with missing 3-month follow-up were excluded from the primary analysis unless the subjects experienced a Primary AE prior to the 3-month visit post-procedure. PV stenosis and AE fistula that occurred \> 1 week and cardiac tamponade/perforation that occurred up to 30 days post ablation were also deemed Primary AEs.

Primary outcome: Effectiveness: Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 15-month Follow-up

Time frame: 15-month follow-up. Number. Unit: Percentage of Participants

Measure	Treatment Group n = 297
Value	59.3

Population analysed: The PP population was used as the primary analysis population. Subjects who did not complete the 15-month follow-up were considered missing and were excluded from the primary analysis unless the subjects experienced effectiveness failure prior to exiting the study.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 15 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Group	85 of 348 (24.4%)	0 of 348 (0%)	2 of 348

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 33290093Natale A, Calkins H, Osorio J, Pollak SJ, Melby D, Marchlinski FE, Athill CA, Delaughter C, Patel AM, Gentlesk PJ, DeVille B, Macle L, Ellenbogen KA, Dukkipati SR, Reddy VY, Mansour M; PRECEPT Investigators. Positive Clinical Benefit on Patient Care, Quality of Life, and Symptoms After Contact Force-Guided Radiofrequency Ablation in Persistent Atrial Fibrillation: Analyses From the PRECEPT Prospective Multicenter Study. Circ Arrhythm Electrophysiol. 2021 Jan;14(1):e008867. doi: 10.1161/CIRCEP.120.008867. Epub 2020 Dec 8.
Derived from this study: PubMed 32819531Mansour M, Calkins H, Osorio J, Pollak SJ, Melby D, Marchlinski FE, Athill CA, Delaughter C, Patel AM, Gentlesk PJ, DeVille B, Macle L, Ellenbogen KA, Dukkipati SR, Reddy VY, Natale A. Persistent Atrial Fibrillation Ablation With Contact Force-Sensing Catheter: The Prospective Multicenter PRECEPT Trial. JACC Clin Electrophysiol. 2020 Aug;6(8):958-969. doi: 10.1016/j.jacep.2020.04.024.

Related trials for Atrial Fibrillation

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

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 principal investigator

Texas Cardiac Arrhythmia Research

Francis Marchlinski, MD principal investigator

University of Pennsylvania

Bruce Koplan, MD principal investigator

Brigham and Women's Hospital

Questions about this trial

What is this clinical trial studying?

A study testing THERMOCOOL SMARTTOUCH® SF catheter 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 9 inclusion and 31 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jan 2021). 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?

Primary Safety Endpoint - Percentage of Participants With Any PAE Within 7 Days (time frame: 7 days (except as noted in analysis population description)). 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 NCT02817776, 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.