Can an unapproved device tame disease? a trial puts it to the test
NCT ID NCT07788989
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 Hide 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Atrial fibrillation are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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.
- Can exercise tame atrial fibrillation? trial tests workouts on heart rhythm and fitness
- Pacemaker lead position may cut heart rhythm complication
- Can zapping the heart beat drugs for AF in heart failure?
- Heart hole or stroke trigger? global registry tracks who gets closure and what happens next
- Two ways to quiet a racing heart: trial pits hybrid ablation against standard catheter treatment
- Stroke's hidden heart rhythm clue under investigation