Aortic Valve StenosisTAVR-ELECTRONCT07390513
Electrophysiological Outcomes After Transcatheter Aortic Valve Replacement
An observational study of Aortic Valve Stenosis and Arrhythmia, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
The TAVR-ELECTRO Registry (Electrophysiological Outcomes After Transcatheter Aortic Valve Replacement) is a single-center, observational cohort study designed to systematically evaluate the occurrence, temporal evolution, and determinants of cardiac arrhythmias following transcatheter aortic valve replacement (TAVR)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Arrhythmia
- What is being tested?
- TAVR Aspirin and clopidogrel
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, 100037
About this study
The TAVR-ELECTRO Registry (Electrophysiological Outcomes After Transcatheter Aortic Valve Replacement) is a single-center, observational cohort study designed to systematically evaluate the occurrence, temporal evolution, and determinants of cardiac arrhythmias following transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis.
This registry retrospectively enrolls consecutive patients undergoing TAVR at Fuwai Hospital, Chinese Academy of Medical Sciences, and collects comprehensive clinical, echocardiographic, electrocardiographic, and procedural data. Particular emphasis is placed on post-procedural electrophysiological outcomes, including ventricular arrhythmias, atrial arrhythmias, and conduction disturbances. Serial rhythm assessments using standard electrocardiography and ambulatory electrocardiographic monitoring are performed during follow-up to characterize arrhythmic burden and its dynamic changes over time.
The primary objective of the TAVR-ELECTRO Registry is to identify clinical, haemodynamic, and procedural factors associated with post-TAVR arrhythmic outcomes and recovery patterns, thereby improving the understanding of electrophysiological remodeling after TAVR and informing post-procedural risk stratification and management strategies.
- Conditions
- Aortic Valve Stenosis, Arrhythmia
- Being tested
- TAVR Aspirin and clopidogrel
- Medical subject headings
- Aortic Valve Stenosis, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVR Aspirin and clopidogrelProcedure or surgery
This is an observational registry study. All participants undergo transcatheter aortic valve replacement (TAVR) as part of standard clinical care for severe aortic stenosis. The choice of valve type (balloon-expandable or self-expanding), valve brand, valve size, access route, and peri-procedural management strategies are determined by the local heart team according to current clinical guidelines and routine practice.
No additional investigational intervention is mandated by the registry protocol. The study does not alter clinical decision-making, procedural techniques, or post-procedural treatment strategies. Instead, the registry systematically collects clinical, echocardiographic, electrocardiographic, and procedural data before and after TAVR to evaluate electrophysiological outcomes.
Post-procedural rhythm assessment, including standard electrocardiography and ambulatory electrocardiographic monitoring, is performed as part of routine follow-up care. Data on ventricular arrhythm
What is being measured
The primary outcome is the main question the study is designed to answer.
Premature Ventricular Contraction (PVC) Response at 12-Month Follow-up
PVC response is defined as a reduction of ≥50% in premature ventricular contraction burden at 12 months compared with baseline. PVC burden is quantified as the total number of premature ventricular contractions per 24 hours, assessed by 24-hour ambulatory electrocardiographic monitoring. Patients without detectable PVCs at baseline are excluded from the primary responder analysis.
Measured: Baseline to 12 months after transcatheter aortic valve replacement (TAVR)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start1 Jan 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pan Xiangbin, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390513
- Sponsor's protocol ID
- 2024-2428
- Other IDs
- NCRC2020009
- Acronym
- TAVR-ELECTRO
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological Outcomes After Transcatheter Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT07390513
- Acronym / sponsor ID
- TAVR-ELECTRO / 2024-2428
- Conditions
- Aortic Valve Stenosis, Arrhythmia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The TAVR-ELECTRO Registry (Electrophysiological Outcomes After Transcatheter Aortic Valve Replacement) is a single-center, observational cohort study designed to systematically evaluate the occurrence, temporal evolution, and determinants of cardiac arrhythmias following transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis.
This registry retrospectively enrolls consecutive patients undergoing TAVR at Fuwai Hospital, Chinese Academy of Medical Sciences, and collects comprehensive clinical, echocardiographic, electrocardiographic, and procedural data. Particular emphasis is placed on post-procedural electrophysiological outcomes, including ventricular arrhythmias, atrial arrhythmias, and conduction disturbances. Serial rhythm assessments using standard electrocardiography and ambulatory electrocardiographic monitoring are performed during follow-up to characterize arrhythmic burden and its dynamic changes over time.
The primary objective of the TAVR-ELECTRO Registry is to identify clinical, haemodynamic, and procedural factors associated with post-TAVR arrhythmic outcomes and recovery patterns, thereby improving the understanding of electrophysiological remodeling after TAVR and informing post-procedural risk stratification and management strategies.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAVR Aspirin and clopidogrelThis is an observational registry study. All participants undergo transcatheter aortic valve replacement (TAVR) as part of standard clinical care for severe aortic stenosis. The choice of valve type (balloon-expandable or self-expanding), valve brand, valve size, access route, and peri-procedural management strategies are determined by the local heart team according to current clinical guidelines and routine practice. No additional investigational intervention is mandated by the registry protocol. The study does not alter clinical decision-making, procedural techniques, or post-procedural treatment strategies. Instead, the registry systematically collects clinical, echocardiographic, electrocardiographic, and procedural data before and after TAVR to evaluate electrophysiological outcomes. Post-procedural rhythm assessment, including standard electrocardiography and ambulatory electrocardiographic monitoring, is performed as part of routine follow-up care. Data on ventricular arrhythm | Procedure or surgery | – |
Primary outcome
Premature Ventricular Contraction (PVC) Response at 12-Month Follow-up
Time frame: Baseline to 12 months after transcatheter aortic valve replacement (TAVR)
PVC response is defined as a reduction of ≥50% in premature ventricular contraction burden at 12 months compared with baseline. PVC burden is quantified as the total number of premature ventricular contractions per 24 hours, assessed by 24-hour ambulatory electrocardiographic monitoring. Patients without detectable PVCs at baseline are excluded from the primary responder analysis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis and Arrhythmia, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Premature Ventricular Contraction (PVC) Response at 12-Month Follow-up (time frame: Baseline to 12 months after transcatheter aortic valve replacement (TAVR)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.