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Lighter sedation may be safer for AFib heart procedure

NCT ID NCT07541339

Symptom relief Sponsor: Beijing Anzhen Hospital 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at 224 adults with a type of irregular heartbeat called paroxysmal atrial fibrillation who are getting a first-time heart procedure called pulsed-field ablation. Researchers want to see if using conscious sedation (being awake but relaxed) is safer than general anesthesia (being fully asleep) during the procedure. The main focus is on whether conscious sedation reduces the risk of dangerously low blood pressure or low oxygen levels during the treatment.

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 224 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Aged 18 to 80 years * Diagnosed with paroxysmal atrial fibrillation * No prior history of catheter ablation for atrial fibrillation/atrial flutter * Scheduled to undergo pulsed-field ablation * Provide written informed consent for study participation and be able to complete all scheduled follow-up assessments Exclusion Criteria: * Obstructive sleep apnea-hypopnea syndrome (OSAHS) * Complicated with severe chronic obstructive pulmonary disease (COPD), asthma or other respiratory system diseases * Body mass index (BMI) \>30 kg/m² or \<20 kg/m² * Preoperative pulse oxygen saturation (SpO₂) \<93% * Anticipated difficult airway * Intolerance to general anesthesia (American Society of Anesthesiologists \[ASA\] physical status ≥Ⅳ) * Current left ventricular ejection fraction (LVEF) ≤40% or New York Heart Association (NYHA) functional class Ⅲ-Ⅳ * Acute coronary syndrome within 3 months * Within 3 months after percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG) or other cardiac/vascular surgeries * Moderate/severe stenosis or severe regurgitation of aortic or mitral valve * Acute cerebrovascular disease within 1 month * Severe hepatic insufficiency (Child-Pugh Class C) * Estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73m² or on dialysis * History of chronic heavy alcohol consumption * History of substance abuse * Hypersensitivity to any medications used in the study protocol * Pregnancy or lactation * Concurrent participation in other interventional clinical trials * Other conditions deemed unsuitable for study participation by the investigators

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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.

Atrial fibrillation (paroxysmal)

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

  • Beijing Anzhen Hospital

    Beijing, Beijing Municipality, 100029, China

More trials for these conditions

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