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New ablation catheter shows promise for treating irregular heartbeat

NCT ID NCT03729830

Disease control Sponsor: Boston Scientific Corporation 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested a new type of catheter (a thin tube) that uses heat to destroy tiny areas of heart tissue causing irregular heartbeats in people with paroxysmal atrial fibrillation (AFib). The catheter has a cooling system to prevent overheating. The trial involved 415 participants and tracked safety and effectiveness for 12 months after the procedure. The goal was to see if this system could safely and effectively stop AFib episodes.

What this could mean

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

Active substance
Open irrigated ablation catheter
What this could lead to
If successful, this could provide a safer and more effective way to treat paroxysmal atrial fibrillation, reducing the need for repeat procedures.
What could go wrong
This is a completed study, so results are already known. The procedure carries risks like stroke, heart damage, or bleeding. It may not work for everyone.

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

415 people

The number who actually took part.

Started

Mar 2019

Finished

May 2024

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

Subjects included in the INTERRUPT AF study should be selected from the investigator's general patient population indicated for catheter ablation of PAF.

Ages

20 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. History of recurrent symptomatic Paroxysmal Atrial Fibrillation, defined as AFib that terminates spontaneously or with intervention within seven days of onset. Minimum documentation includes a physician's note indicating recurrent self-terminating Atrial Fibrillation AND one electrocardiographically documented AF episode within 6 months prior to enrollment. 2. Subjects who are eligible for an ablation procedure for Paroxysmal Atrial Fibrillation with the Rhythmia Mapping system according to current international and local guidelines 3. Subjects who are eligible for an ablation procedure for Paroxysmal Atrial Fibrillation with a Boston Scientific Open-Irrigated Ablation Catheter according to current international and local guidelines 4. Subjects who are willing and capable of providing informed consent 5. Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center 6. Subjects whose age is 20 years or above, or who are of legal age to give informed consent specific to state and national law. Exclusion Criteria: 1. Subjects enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, without the written approval from Boston Scientific 2. Subjects unable or unwilling to complete follow-up visits and examination for the duration of the study 3. Subjects who have undergone any previous left atrial cardiac ablation (RF, Cryo, surgical) 4. Subjects who have undergone any cardiac ablation within 30 days prior to enrollment 5. Unrecovered/unresolved Adverse Events from any previous invasive procedure 6. Life expectancy \<= three years per physician opinion 7. Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion) 8. Known cardiac thrombus within 60 days prior to enrollment 9. History of CVA, TIA or PE within 90 days prior to enrollment 10. Implanted pacemaker, ICD, or CRT leads within 90 days prior to enrollment 11. Implanted Left atrial appendage closure device prior to the index procedure 12. Prosthetic mitral or tricuspid heart valves (subjects with successful mitral valve repair allowed- annular ring constitutes repair) 13. Left atrial diameter greater than 5.5cm 14. Documented or suspected stenosis of any pulmonary veins. 15. Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause. 16. Contraindication for anticoagulation 17. Clinically significant mitral valve regurgitation or stenosis per investigator discretion. 18. Any cardiac surgery ≤ 90 days from consent date. 19. Any electrocardiographically documented episode of Persistent AFib, defined as AFib lasting longer than 7 days from onset.

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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

  • AdventHealth Orlando

    Orlando, Florida, 32803, United States

  • Bethesda North Hospital

    Cincinnati, Ohio, 45220, United States

  • Broward General Medical Center

    Miami, Florida, 33136, United States

  • Catholic Medical Center

    Manchester, New Hampshire, 03102, United States

  • Centre Hospitalier Princesse Grace

    Monaco, 98000, Monaco

  • Christus Trinity Mother Frances Health System

    Tyler, Texas, 75701, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-1000, United States

  • HeartPlace Mid-Cities EP

    Bedford, Texas, 76021, United States

  • Juedisches Krankenhaus Berlin

    Mitte, 13347, Germany

  • Kaleida Health

    Buffalo, New York, 14213, United States

  • Keimyung University Dongsan Medical Center

    Daegu, 42601, South Korea

  • Kokura Memorial Hospital

    Fukuoka-ken, 802-8555, Japan

  • Korea University Medical Center

    Seoul, 2841, South Korea

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103, United States

  • Nebraska Heart Institute

    Lincoln, Nebraska, 68526, United States

  • Orion Medical

    Pasadena, Texas, 77505, United States

  • Papworth Hospital

    Cambridge, CB2 0AY, United Kingdom

  • St. John's Hospital

    Springfield, Illinois, 62769, United States

  • St. Lukes Idaho Cardiology Associates

    Boise, Idaho, 83712, United States

  • Staedtisches Klinikum Karlsruhe

    Karlsruhe, 76133, Germany

  • Torrance Memorial Medical Center

    Torrance, California, 90505, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Chicago Hospital

    Chicago, Illinois, 60637, United States

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242, United States

  • Yokosuka Kyosai Hospital

    Kanagawa Prefecture, 238-8558, Japan

More trials for these conditions

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