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New study tracks heartbeat irregularities after valve procedure

NCT ID NCT07390513

Knowledge-focused Sponsor: Chinese Academy of Medical Sciences, Fuwai 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study follows 1000 patients who had a standard aortic valve replacement (TAVR) to see how their heart rhythms change over a year. Researchers will track abnormal heartbeats using ECG monitors. The goal is to learn which patients are at risk for rhythm problems and how they recover.

What this could mean

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

What this could lead to
If successful, this study could help doctors better predict and manage heart rhythm problems after TAVR, improving patient care.
What could go wrong
This is an observational registry, not a treatment trial. It cannot prove that any intervention causes or prevents arrhythmias. Results may not apply to all TAVR patients.

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 1,000 people

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

Started

Jan 2022

Expected to finish

Dec 2026

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.

Who is studied

The study population consists of adult patients with severe aortic stenosis who undergo transcatheter aortic valve replacement (TAVR) as part of routine clinical care at Fuwai Hospital, Chinese Academy of Medical Sciences. Eligible participants include consecutive patients who receive TAVR and undergo systematic post-procedural rhythm evaluation as part of standard follow-up. The registry focuses on patients with available baseline and follow-up electrocardiographic assessments, allowing for longitudinal evaluation of cardiac arrhythmias after TAVR. Particular attention is given to ventricular arrhythmias, including premature ventricular contractions, as well as atrial arrhythmias and conduction disturbances occurring during follow-up. This study population reflects a real-world cohort of patients treated with contemporary TAVR devices and management strategies, providing comprehensive clinical, echocardiographic, electrocardiographic, and procedural data to characterize electrophysi

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: Age ≥18 years at the time of transcatheter aortic valve replacement (TAVR). Diagnosis of severe aortic stenosis based on current guideline-recommended echocardiographic criteria. Undergoing transcatheter aortic valve replacement (TAVR) as part of routine clinical care. Availability of baseline electrocardiographic assessment, including ambulatory electrocardiographic monitoring for evaluation of premature ventricular contraction (PVC) burden. Completion of post-procedural rhythm follow-up, including ambulatory electrocardiographic monitoring at 12 months after TAVR. Ability to provide informed consent or availability of legally authorized consent, as required by the institutional review board. Exclusion Criteria: Absence of premature ventricular contractions at baseline (PVC burden = 0), as PVC response cannot be meaningfully assessed in this population. Presence of a permanent pacemaker or implantable cardioverter-defibrillator prior to TAVR. Receipt of catheter ablation for atrial or ventricular arrhythmias before TAVR or during the follow-up period. Death occurring during the index hospitalization or before completion of rhythm follow-up. Inability to complete scheduled electrocardiographic or ambulatory rhythm assessments during follow-up. Missing or incomplete key electrocardiographic, echocardiographic, or follow-up data required for outcome assessment.

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis Arrhythmias, Cardiac cardiac rhythm disease

As listed by the trial registrant

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

Aortic valve stenosis Arrhythmia

Contacts and locations

Locations

  • National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences

    Beijing, 100037, China

More trials for these conditions

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