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Can an unapproved device tame disease? a trial puts it to the test

NCT ID NCT07788989

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 27, 2026 · Last updated Sep 16, 2026 · Updated 3 times

Summary

Researchers are testing a medical device that has not been approved or cleared by the U.S. FDA. The trial aims to see whether the device can help control a disease, possibly by reducing symptoms or slowing its course. Participants receive the device as part of the study, and the team will measure how well it works and how safe it is.

What this could mean

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

Active substance
an experimental medical device not yet approved or cleared by the U.S. FDA
What this could lead to
If the device works, it could offer a new way to manage the disease, potentially reducing symptoms or slowing its progression.
What could go wrong
The device is not yet approved, and this trial is early. It may not work as hoped, and there could be unknown risks or side effects.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 2,300 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2029

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.

Ages

18 to 80 years

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: * Participant has been diagnosed with either atrial fibrillation (AF) subtype (paroxysmal (AF episodes that start suddenly and typically last less than 7 days, often resolving in 24 hours) or persistent (AF lasting more than 7 days in duration and less than 365 days in duration, documented by )): 1. A physician's note documenting diagnosis of symptomatic PAF/PsAF, as defined above AND 2. PAF: At least one (1) AF episode electrocardiographically documented within 12 months prior to enrollment 3. PsAF: Two electrocardiograms (ECGs) showing continuous AF, with electrocardiogram taken at least 7 days apart (electrocardiograms cannot be more than (\>) 365 days prior to enrollment) OR A 24-hour arrhythmia monitor documenting continuous AF within the last 365 days * Participant is aged 18-80 years at the time of informed consent * Participant is willing and capable of providing informed consent * Participant is able and willing to comply with all pre-, post-, and follow-up testing and requirements Exclusion Criteria: * Participant has continuous AF \> 365 days (longstanding persistent AF) * Participant has AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, untreated documented obstructive sleep apnea, acute alcohol toxicity, et cetera) * Participant has previous surgical or catheter ablation for AF * Participant is known to require ablation outside the left atrium (LA), superior vena cava (SVC), and cavotricuspid isthmus (CTI) region (for example, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, ventricular tachycardia and wolff-parkinson-white) * Participant has severe dilatation of the LA (LAD \> 50 millimeter \[mm\]) of the antero-posterior diameter confirmed by imaging performed within 180 days prior to enrollment * Participant has LA thrombus confirmed by imaging within 48 hours prior to the procedure * Participant has severely compromised left ventricular ejection fraction (LVEF \< 40 percent \[%\]) confirmed by imaging performed within 180 days prior to enrollment * Participant has uncontrolled heart failure or new york heart association (NYHA) Class III or IV * Participant has a history of blood clotting, bleeding abnormalities or contraindication to anticoagulation (for example, heparin) * Participant has had a thromboembolic event (including transient ischemic attack \[TIA\]) within 180 prior to enrollment * Participant has had a percutaneous coronary intervention or acute myocardial infarction (MI) within 60 days prior to enrollment * Participant has had coronary artery bypass grafting (CABG) surgery within 180 days prior to enrollment * Participant has had valvular cardiac surgical/percutaneous procedure (for example, ventriculotomy, atriotomy, valve repair or replacement, and presence of a prosthetic valve) * Participant has had unstable angina within 6 months prior to enrollment * Participant has anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 365 days post-procedure * Participant has significant pulmonary disease (for example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms * Participant has a significant congenital anomaly (for example, atrial septal defects \[ASDs\]) including repaired defects or medical problems that in the opinion of the Investigator would preclude enrollment in this study * Participant has an existing diagnosis of pulmonary vein stenosis (PVS) * Participant has a pre-existing hemi-diaphragmatic paralysis * Participant has an acute illness, active systemic infection, or sepsis * Participant has an intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation * Participant has severe mitral regurgitation (Regurgitant volume greater than or equal to (\>=) 60 milliliter per beat (mL/beat), regurgitant fraction \>= 50%, and/or effective regurgitant orifice area \>=0.40 centimeter square \[cm\^2\]) * Participant has an implanted metal cardiac device, including MitraClip and left atrial appendage occlusion (LAAO) devices (for example, WATCHMAN, Amulet, et cetera.) (this exclusion does not include coronary stents, implanted pacemakers, implantable cardioverter-defibrillators (ICD), and an implantable loop recorders (ILR)) * Participant has a condition that precludes vascular access (such as inferior vena cava (IVC) filter) * Participant is currently enrolled in another investigational device or drug study * Participant is pregnant, lactating, or is of child-bearing potential and plans on trying to become pregnant during the course of the clinical investigation * Participant has a life expectancy less than 365 days

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ascension Texas Cardiovascular

    Austin, Texas, 78705, United States

More trials for these conditions

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