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New catheter combo aims to keep AFib in check longer

NCT ID NCT03963349

Disease control Sponsor: Biosense Webster, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This study looks at how well a special catheter (THERMOCOOL SMARTTOUCH SF) and software (Ablation Index) work to treat paroxysmal atrial fibrillation, a type of irregular heartbeat. Researchers will track 150 adults who get this procedure to see if they stay free of heart rhythm problems for up to a year. The goal is to improve the safety and long-term success of the ablation procedure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
radiofrequency ablation using THERMOCOOL SMARTTOUCH SF catheter with Ablation Index software
What this could lead to
If successful, this could confirm that using this specific catheter and software improves long-term control of atrial fibrillation with fewer repeat procedures.
What could go wrong
This is a single-center, real-world study with only 150 participants, so results may not apply to all patients. The procedure carries standard risks like bleeding, infection, or heart rhythm changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2019

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

PAF population patients

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 18 years or older 2. Patient has PAF eligible for AI-guided catheter ablation with an STSF catheter per standard of care assessment 3. Able and willing to comply with all pre-, post- and follow-up testing and requirements 4. Able to sign EC-approved informed consent form Exclusion Criteria: 1. AF is secondary to electrolyte imbalance, thyroid disease, or a reversible or non-cardiac cause 2. Patient has AF episodes lasting longer than 7 days 3. History of heart surgery, or any previous ablation for AF 4. Myocardial infarction (MI), coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within preceding 3 months 5. Documented left atrial thrombus on imaging 6. New York Heart Association (NYHA) class III or IV heart failure 7. Hypertrophic obstructive cardiomyopathy 8. Presence of implantable cardioverter defibrillator (ICD) 9. Contraindication to isoproterenol 10. Any other disease or malfunction that would preclude treatment with ablation in the opinion of the investigator 11. Women who are pregnant and/or breast feeding 12. Enrollment in an investigational study evaluating another device, biologic, or drug

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Conditions

The condition(s) this trial relates to.

atrial fibrillation paroxysmal atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Paroxysmal atrial fibrillation

Contacts and locations

Locations

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.