Tricuspid RegurgitationNCT06922526
Pacemaker-related Tricuspid Regurgitation Progression and Long-term Outcomes
An observational study of Tricuspid Regurgitation and Pacemaker, run by Haiyan Wang at 1 site in China.
Trial summary
Tricuspid regurgitation (TR) is a common complication following cardiac implantable electronic device (CIED) implantation, with severe TR being associated with increased rates of heart failure hospitalization and all-cause mortality, significantly impairing patients' quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation, Pacemaker
- What is being tested?
- Pacemaker implantation
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Apr 2025to May 2026
- 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: Patients after cardiac pacemaker implantation
Who may be able to join
- Adult patients
- Patients with an implantable electronic heart device (CIEDs)
- The patient underwent pacemaker implantation at Qianfoshan Hospital between 2015 and 2025
Who cannot join
- Patients with severe tricuspid regurgitation or those who have undergone tricuspid valve surgery or interventional treatment prior to pacemaker implantation
- Patients with severe valvular heart disease, congenital heart disease, or arrhythmias
- Patients with single-chamber pacemakers or poor images
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Shandong First Medical University
Jinan, 250000
Haiyan Wang, MD, 86-13583184107, wanghaiyan96@126.com
About this study
Official title: Predictors of Tricuspid Regurgitation Progression and Adverse Outcomes in Different Pacing Modes
Tricuspid regurgitation (TR) is a common complication following cardiac implantable electronic device (CIED) implantation, with severe TR being associated with increased rates of heart failure hospitalization and all-cause mortality, significantly impairing patients' quality of life. With technological advancements, physiological pacing modalities have demonstrated superior clinical efficacy and safety profiles compared to conventional pacing methods.
This study aims to evaluate predictors of adverse outcomes and TR progression in CIED recipients under different pacing modalities, thereby providing clinical guidance for high-risk patients.
Read the detailed description
This retrospective study analyzed patients undergoing pacemaker implantation from January 2015 to March 2025, stratified by pacing modality (right ventricular/conduction system/biventricular pacing) and TR progression (worsened [≥1-grade increase] vs non-worsened TR).
The protocol included: (1) 3D echocardiographic assessment of TR mechanisms, (2) quantitative fluoroscopic analysis of lead parameters (tension, mobility, angulation), (3) multivariable regression evaluating pacing modes and TR progression on clinical outcomes, and (4) documentation of device-related complications (lead dislodgement/infection) and heart failure rehospitalization.
- Conditions
- Tricuspid Regurgitation, Pacemaker
- Being tested
- Pacemaker implantation
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker implantationDevice
Pacemaker implantation methods include right ventricular pacing, biventricular pacing, conduction system pacing
| Study group | Role | What they receive |
|---|---|---|
| Right ventricular pacing group | Not described Receives: Device: Pacemaker implantation | |
| conduction system pacing group | Not described Receives: Device: Pacemaker implantation | |
| biventricular pacing group | Not described Receives: Device: Pacemaker implantation | |
| TR progression group | Not described | |
| non-TR progression group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tricuspid regurgitation progression（Progression of tricuspid regurgitation ≥ grade 0.5）
Grading of tricuspid regurgitation severity:Grade 0: None
Grade 0.5: Trace
Grade 1: Mild
Grade 1.5: Mild to moderate
Grade 2: Moderate
Grade 2.5: Moderate to severe
Grade 3: Severe
Measured: Mean follow-up of 1 year
Secondary outcomes (1)
Heart Failure Readmission Rate After CIED Implantation
Measured: Mean follow-up of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study startApr 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tricuspid RegurgitationStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haiyan Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Haiyan Wang, Qianfoshan Hospital
- Investigators
- Haiyan Wang, MD, Principal investigator, Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922526
- Sponsor's protocol ID
- SDYWZGKCJH2024030
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoke U, Auger D, Thijssen J, Wolterbeek R, van der Velde ET, Holman ER, Schalij MJ, Bax JJ, Delgado V, Marsan NA. Significant lead-induced tricuspid regurgitation is associated with poor prognosis at long-term follow-up. Heart. 2014 Jun;100(12):960-8. doi: 10.1136/heartjnl-2013-304673. Epub 2014 Jan 21.
PubMed 24449717Li X, Fan X, Wang Q, Wang Z, Zhu H, Li H, Wang H, Liu Z, Yao Y. Tricuspid regurgitation following pacemaker implantation for bradycardia: a two-year study comparing different pacing strategies. Chin Med J (Engl). 2023 Oct 20;136(20):2508-2510. doi: 10.1097/CM9.0000000000002825. Epub 2023 Aug 31. No abstract available.
PubMed 37649400Li X, Zhu H, Fan X, Wang Q, Wang Z, Li H, Tao J, Wang H, Liu Z, Yao Y. Tricuspid regurgitation outcomes in left bundle branch area pacing and comparison with right ventricular septal pacing. Heart Rhythm. 2022 Jul;19(7):1202-1203. doi: 10.1016/j.hrthm.2022.03.005. Epub 2022 Mar 10. No abstract available.
PubMed 35278699
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Tricuspid Regurgitation Progression and Adverse Outcomes in Different Pacing Modes
- ClinicalTrials.gov ID
- NCT06922526
- Acronym / sponsor ID
- SDYWZGKCJH2024030
- Conditions
- Tricuspid Regurgitation, Pacemaker
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Haiyan WangUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 10 Apr 2025 (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.
Tricuspid regurgitation (TR) is a common complication following cardiac implantable electronic device (CIED) implantation, with severe TR being associated with increased rates of heart failure hospitalization and all-cause mortality, significantly impairing patients' quality of life. With technological advancements, physiological pacing modalities have demonstrated superior clinical efficacy and safety profiles compared to conventional pacing methods.
This study aims to evaluate predictors of adverse outcomes and TR progression in CIED recipients under different pacing modalities, thereby providing clinical guidance for high-risk patients.
Detailed description
This retrospective study analyzed patients undergoing pacemaker implantation from January 2015 to March 2025, stratified by pacing modality (right ventricular/conduction system/biventricular pacing) and TR progression (worsened [≥1-grade increase] vs non-worsened TR).
The protocol included: (1) 3D echocardiographic assessment of TR mechanisms, (2) quantitative fluoroscopic analysis of lead parameters (tension, mobility, angulation), (3) multivariable regression evaluating pacing modes and TR progression on clinical outcomes, and (4) documentation of device-related complications (lead dislodgement/infection) and heart failure rehospitalization.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Right ventricular pacing group | – | Device: Pacemaker implantation |
| conduction system pacing group | – | Device: Pacemaker implantation |
| biventricular pacing group | – | Device: Pacemaker implantation |
| TR progression group | – | – |
| non-TR progression group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after cardiac pacemaker implantation
Key inclusion criteria (3 listed)
- Adult patients
- Patients with an implantable electronic heart device (CIEDs)
- The patient underwent pacemaker implantation at Qianfoshan Hospital between 2015 and 2025
Key exclusion criteria (3 listed)
- Patients with severe tricuspid regurgitation or those who have undergone tricuspid valve surgery or interventional treatment prior to pacemaker implantation
- Patients with severe valvular heart disease, congenital heart disease, or arrhythmias
- Patients with single-chamber pacemakers or poor images
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 |
|---|---|---|
| Pacemaker implantationPacemaker implantation methods include right ventricular pacing, biventricular pacing, conduction system pacing | Device | Right ventricular pacing group, biventricular pacing group, conduction system pacing group |
Primary outcome
Tricuspid regurgitation progression（Progression of tricuspid regurgitation ≥ grade 0.5）
Time frame: Mean follow-up of 1 year
Grading of tricuspid regurgitation severity:Grade 0: None Grade 0.5: Trace Grade 1: Mild Grade 1.5: Mild to moderate Grade 2: Moderate Grade 2.5: Moderate to severe Grade 3: Severe
1 secondary outcome
Heart Failure Readmission Rate After CIED Implantation
Time frame: Mean follow-up of 1 year
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 30 Apr 2025.
- Background: PubMed 24449717Hoke U, Auger D, Thijssen J, Wolterbeek R, van der Velde ET, Holman ER, Schalij MJ, Bax JJ, Delgado V, Marsan NA. Significant lead-induced tricuspid regurgitation is associated with poor prognosis at long-term follow-up. Heart. 2014 Jun;100(12):960-8. doi: 10.1136/heartjnl-2013-304673. Epub 2014 Jan 21.
- Background: PubMed 37649400Li X, Fan X, Wang Q, Wang Z, Zhu H, Li H, Wang H, Liu Z, Yao Y. Tricuspid regurgitation following pacemaker implantation for bradycardia: a two-year study comparing different pacing strategies. Chin Med J (Engl). 2023 Oct 20;136(20):2508-2510. doi: 10.1097/CM9.0000000000002825. Epub 2023 Aug 31. No abstract available.
- Background: PubMed 35278699Li X, Zhu H, Fan X, Wang Q, Wang Z, Li H, Tao J, Wang H, Liu Z, Yao Y. Tricuspid regurgitation outcomes in left bundle branch area pacing and comparison with right ventricular septal pacing. Heart Rhythm. 2022 Jul;19(7):1202-1203. doi: 10.1016/j.hrthm.2022.03.005. Epub 2022 Mar 10. No abstract available.
- 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.
Haiyan Wang, MD principal investigator
Shandong First Medical University
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 Tricuspid Regurgitation and Pacemaker, run by Haiyan Wang 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 30 Apr 2025. 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?
Contact Haiyan Wang, MD (86-13583184107, wanghaiyan96@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tricuspid regurgitation progression（Progression of tricuspid regurgitation ≥ grade 0.5） (time frame: Mean follow-up of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06922526, which also lists 3 linked publications.
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 30 Apr 2025.