Heart Failure With Reduced Ejection FractionNCT05575557
Pulmonary Artery Pressure and Right Heart Evaluation for Patients Requiring Physiological Pacing Treatment
A study testing Right heart catheterization in people with Heart Failure With Reduced Ejection Fraction and Atrial Fibrillation, Persistent, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
With the aging of society, the use of cardiac pacing in patients with irreversible bradycardia is increasingly widespread. As early as the 1950s, right ventricular pacing (RVP) began to be used in patients with atrioventricular block or sick sinus syndrome, but in fact such pacing could cause ventricular asynchrony… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction, Atrial Fibrillation, Persistent, Sick Sinus Syndrome
- What is being tested?
- Right heart catheterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age over 18
- persistent atrial fibrillation patients with uncontrolled heart rate requiring atrioventricular node ablation
- patients with sick sinus syndrome or atrioventricular block eligible for pacemaker implantation
- patients who can understand and sign informed consent
Who cannot join
- age below 18 or over 99
- concomitant diseases that may affect right heart function, including COPD, pulmonary infection, history of pulmonary embolism or right myocardial infarction, myocarditis, systemic disease
- patients with temporary pacemaker implanted
- right heart catheterization contraindications, including acute infection and embolic events
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 210000
Yawei Xu, +86 18917683030, xuyawei@tongji.edu.cn
About this study
With the aging of society, the use of cardiac pacing in patients with irreversible bradycardia is increasingly widespread. As early as the 1950s, right ventricular pacing (RVP) began to be used in patients with atrioventricular block or sick sinus syndrome, but in fact such pacing could cause ventricular asynchrony, which could lead to long-term myocardial perfusion injury, valvular regurgitation, heart failure, and increased risk of ventricular tachycardia and ventricular fibrillation. The latest guideline recommended reducing the proportion of right ventricular pacing. Additionally, in patients with heart failure with reduced ejection fraction (EF ≤ 35%) and complete left bundle branch block, cardiac resynchronization therapy (CRT) with biventricular pacing (BVP) has been recommended to improve cardiac function, but only about 30% of patients benefit from it, which may be related to poor left ventricular pacing site and myocardial scarring. In theory, His bundle pacing (HBP) compared with RVP can reduce the risk of functional tricuspid regurgitation when the lead position lies on the atrial side of the tricuspid valve, which may improve the right heart function and pulmonary artery pressure. In 2021, Domenico Grieco et al. explored the effect of HBP on right heart function. After 6 months of follow-up, it was found that HBP improved right heart function and pulmonary artery pressure compared with RVP.
At present, there are few discussions on the effect of physiological pacing on right ventricular hemodynamics, and the sample size is small. Internationally, the discussion of the assessment of hemodynamics is limited to non-invasive evaluation (such as echocardiography, ECG, SPECT) The gold standard for right heart hemodynamics evaluation is the measurement of invasive right heart catheterization, and there has been no relevant research so far, so the investigators further designed a study of the effect of physiological pacing on hemodynamics.
Read the detailed description
This study was designed to investigate the acute and chronic effect of different pacing methods on the function of pulmonary artery and right heart.
Studied population: The investigated population are patients eligible for pacemaker implantation and cardiac resynchronization therapy and specified as followed:
- age over 18; 2. persistent atrial fibrillation patients with uncontrolled heart rate requiring atrioventricular node ablation; 3. heart failure patients with EF≤35% and complete left bundle branch block; 4. patients with sick sinus syndrome or atrioventricular block eligible for pacemaker implantation.
Investigated procedure: Physiological pacing as the principal studied procedure is defined as pacing with ventricular lead implanted at proximal/distal His bundle or left bundle branch. While right ventricular pacing was defined as conventional pacing with ventricular lead implanted at right ventricular apex.
Importantly, Swan-Ganz catheter was performed before and after physiological pacing. By the internal jugular vein before the pacemaker implantation procedure. After the measurement, the catheter was indwelled and measurement was taken. Thereafter, pacemaker implantation procedure was followed. After completing electrode fixation and continuous ventricular pacing for at least 5 minutes, ensuring ventricular pacing ratio > 80%, the SW catheter measurement was performed again to acquire indices under physiological pacing.
Follow up: The study is designed to have scheduled follow-up at 1 month, 3-month, 6-month and 12 months after procedure. Primary endpoint is a composite endpoint of all-cause mortality and HF rehospitalization. And other imageological measurement (echocardiography) biochemical test (blood BNP) and functional evaluation (6MWT) were performed to appraise the impact of physiological pacing on the condition of the participants.
- Conditions
- Heart Failure With Reduced Ejection Fraction, Atrial Fibrillation, Persistent, Sick Sinus Syndrome, Atrioventricular Block
- Being tested
- Right heart catheterization
- Keywords
- physiological pacing, right heart, hemodynamics examination, acute and chronic impact
- Medical subject headings
- Atrial Fibrillation, Sick Sinus Syndrome, Atrioventricular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right heart catheterizationProcedure or surgery
All groups were detected with SW catheter by the internal jugular vein before the procedure. After the measurement, the catheter was indwelled, and the pacemaker implantation procedure was started. After ventricular pacing for 5 minutes, the SW catheter measurement was performed again. After the measurement, the SW catheter was withdrawn.
| Study group | Role | What they receive |
|---|---|---|
| His bundle pacing group | Active comparator | HBP was performed on the patient, and the detection of the His bundle potential during the procedure is the sign of the success of the procedure. The HB capture threshold was accepted if lower than 3.0 V at 0.42ms. Receives: Procedure: Right heart catheterization |
| Left branch bundle pacing group | Active comparator | HBP was performed on the patient, and the detection of the His bundle potential during the procedure is the sign of the success of the procedure. During the procedure, the duration from the pacing signal to the peak of R wave (on V4-V6 lead) is measured as pacing to left ventricular activation time (p-LVAT). An eligible site of left bundle capture was confirmed if selective LBBP was demonstrated by ECG, if p-LVAT shortened abruptly >10 ms through increasing pacing output, or if p-LVAT stayed shortest and stable at the site. Receives: Procedure: Right heart catheterization |
| Right ventricular pacing group | Active comparator | If we could not achieve an acceptable HB or LBB capture after five attempts of lead positioning or a fluoroscopy exposure time over 30min, the lead was then placed in the RV with traditional approach. Receives: Procedure: Right heart catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events after procedure
rehospitalization due to acute heart failure, all-cause mortality, cardiac death
Measured: From date of inclusion until the date of documented adverse events, assessed up to 1 year
Secondary outcomes (12)
Changes in systolic, diastolic and mean pulmonary artery pressure by Swan-Ganz catheter from pre-procedure level
Measurement of systolic, diastolic and pulmonary artery pressure by Swan-Ganz catheter before and 5 minutes after ventricular pacing lead implantation
Measured: 5 minutes after ventricular pacing lead implantation
Changes in systolic, diastolic and mean right ventricular pressure by Swan-Ganz catheter from pre-procedure level
Measurement of systolic, diastolic and mean right ventricular pressure by Swan-Ganz catheter before and 5 minutes after ventricular pacing lead implantation
Measured: 5 minutes after ventricular pacing lead implantation
Changes in systolic, diastolic and mean right atrial pressure by Swan-Ganz catheter from pre-procedure level
Measurement of systolic, diastolic and mean right atrial pressure by Swan-Ganz catheter before and 5 minutes after ventricular pacing lead implantation
Measured: 5 minutes after ventricular pacing lead implantation
Changes in right ventricular global longitudinal strain rate from pre-porcedure level
Right ventricular global longitudinal strain rate measured at four-chamber view
Measured: 24 hours post procedure, 1st month, 3rd month, 12th month since procedure
Changes in tricuspid annular plane systolic excursion from pre-procedure level
Tricuspid annular plane systolic excursion by tissue doppler imaging measured at four-chamber view
Measured: 24 hours post procedure, 1st month, 3rd month, 12th month since procedure
Changes in Tei index from pre-procedure level
Tei index calculated from measurement by tissue doppler imaging of tricuspid moving velocity at four-chamber view
Measured: 24 hours post procedure, 1st month, 3rd month, 12th month since procedure
Changes in pulmonary artery systolic pressure by echocardiography from pre-procedure level
Pulmonary artery systolic pressure was approximated by echocardiography measuring tricuspid regurgitation pressure
Measured: 24 hours post procedure, 1st month, 3rd month, 12th month since procedure
Change from baseline walking distance of 6-min walk test between different groups at 6 month after procedure
Maximum walking distance measured from 6-min walk test
Measured: 1st month, 3rd month, 12th month since procedure
Change from baseline general quality of life evaluation
Change in EQ-5D-5L questionnaire score
Measured: 1st month, 3rd month, 12th month since procedure
Change from baseline heart failure-specific quality of life evaluation
Change in Kansas City Cardiomyopathy Questionnaire score
Measured: 1st month, 3rd month, 12th month since procedure
Change in heart failure biomarker from baseline
Change in level of blood brain natriuretic peptide
Measured: 1st month, 3rd month, 12th month since procedure
Changes in blood pressure from baseline between different groups at 6 months after procedure
Change of systolic and diastolic blood pressure, an average value of three times
Measured: 1st month, 3rd month, 12th month since procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start1 Nov 2022
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Reduced Ejection FractionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
- Investigators
- Yawei Xu, Principal investigator, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575557
- Sponsor's protocol ID
- PROPHET
- Status last verified
- Oct 2022
- First submitted
- 17 Sep 2022
- Last updated
- 29 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Su Y, Xu X, Xie D, Ren Z, Tang K, Li H, Zhang J, Wu S, Sun H, Xu Y, Li Y, Zhao D, Che W. PCWP Characterizes Responders of Left Bundle Branch Area Pacing in HFpEF Population. JACC Asia. 2026 Oct 14:S2772-3747(26)00789-1. doi: 10.1016/j.jacasi.2026.08.030. Online ahead of print.
PubMed 42886112
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Artery Pressure and Right Heart Evaluation for Patients Requiring Physiological Pacing Treatment
- ClinicalTrials.gov ID
- NCT05575557
- Acronym / sponsor ID
- PROPHET
- Conditions
- Heart Failure With Reduced Ejection Fraction, Atrial Fibrillation, Persistent, Sick Sinus Syndrome, Atrioventricular Block
- Keywords
- physiological pacing, right heart, hemodynamics examination, acute and chronic impact
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 12 Oct 2022 (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.
With the aging of society, the use of cardiac pacing in patients with irreversible bradycardia is increasingly widespread. As early as the 1950s, right ventricular pacing (RVP) began to be used in patients with atrioventricular block or sick sinus syndrome, but in fact such pacing could cause ventricular asynchrony, which could lead to long-term myocardial perfusion injury, valvular regurgitation, heart failure, and increased risk of ventricular tachycardia and ventricular fibrillation. The latest guideline recommended reducing the proportion of right ventricular pacing. Additionally, in patients with heart failure with reduced ejection fraction (EF ≤ 35%) and complete left bundle branch block, cardiac resynchronization therapy (CRT) with biventricular pacing (BVP) has been recommended to improve cardiac function, but only about 30% of patients benefit from it, which may be related to poor left ventricular pacing site and myocardial scarring. In theory, His bundle pacing (HBP) compared with RVP can reduce the risk of functional tricuspid regurgitation when the lead position lies on the atrial side of the tricuspid valve, which may improve the right heart function and pulmonary artery pressure. In 2021, Domenico Grieco et al. explored the effect of HBP on right heart function. After 6 months of follow-up, it was found that HBP improved right heart function and pulmonary artery pressure compared with RVP.
At present, there are few discussions on the effect of physiological pacing on right ventricular hemodynamics, and the sample size is small. Internationally, the discussion of the assessment of hemodynamics is limited to non-invasive evaluation (such as echocardiography, ECG, SPECT) The gold standard for right heart hemodynamics evaluation is the measurement of invasive right heart catheterization, and there has been no relevant research so far, so the investigators further designed a study of the effect of physiological pacing on hemodynamics.
Detailed description
This study was designed to investigate the acute and chronic effect of different pacing methods on the function of pulmonary artery and right heart.
Studied population: The investigated population are patients eligible for pacemaker implantation and cardiac resynchronization therapy and specified as followed:
- age over 18; 2. persistent atrial fibrillation patients with uncontrolled heart rate requiring atrioventricular node ablation; 3. heart failure patients with EF≤35% and complete left bundle branch block; 4. patients with sick sinus syndrome or atrioventricular block eligible for pacemaker implantation.
Investigated procedure: Physiological pacing as the principal studied procedure is defined as pacing with ventricular lead implanted at proximal/distal His bundle or left bundle branch. While right ventricular pacing was defined as conventional pacing with ventricular lead implanted at right ventricular apex.
Importantly, Swan-Ganz catheter was performed before and after physiological pacing. By the internal jugular vein before the pacemaker implantation procedure. After the measurement, the catheter was indwelled and measurement was taken. Thereafter, pacemaker implantation procedure was followed. After completing electrode fixation and continuous ventricular pacing for at least 5 minutes, ensuring ventricular pacing ratio > 80%, the SW catheter measurement was performed again to acquire indices under physiological pacing.
Follow up: The study is designed to have scheduled follow-up at 1 month, 3-month, 6-month and 12 months after procedure. Primary endpoint is a composite endpoint of all-cause mortality and HF rehospitalization. And other imageological measurement (echocardiography) biochemical test (blood BNP) and functional evaluation (6MWT) were performed to appraise the impact of physiological pacing on the condition of the participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| His bundle pacing group | Active comparator | Procedure: Right heart catheterizationHBP was performed on the patient, and the detection of the His bundle potential during the procedure is the sign of the success of the procedure. The HB capture threshold was accepted if lower than 3.0 V at 0.42ms. |
| Left branch bundle pacing group | Active comparator | Procedure: Right heart catheterizationHBP was performed on the patient, and the detection of the His bundle potential during the procedure is the sign of the success of the procedure. During the procedure, the duration from the pacing signal to the peak of R wave (on V4-V6 lead) is measured as pacing to left ventricular activation time (p-LVAT). An eligible site of left bundle capture was confirmed if selective LBBP was demonstrated by ECG, if p-LVAT shortened abruptly >10 ms through increasing pacing output, or if p-LVAT stayed shortest and stable at the site. |
| Right ventricular pacing group | Active comparator | Procedure: Right heart catheterizationIf we could not achieve an acceptable HB or LBB capture after five attempts of lead positioning or a fluoroscopy exposure time over 30min, the lead was then placed in the RV with traditional approach. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age over 18
- persistent atrial fibrillation patients with uncontrolled heart rate requiring atrioventricular node ablation
- patients with sick sinus syndrome or atrioventricular block eligible for pacemaker implantation
- patients who can understand and sign informed consent
Key exclusion criteria (4 listed)
- age below 18 or over 99
- concomitant diseases that may affect right heart function, including COPD, pulmonary infection, history of pulmonary embolism or right myocardial infarction, myocarditis, systemic disease
- patients with temporary pacemaker implanted
- right heart catheterization contraindications, including acute infection and embolic events
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 |
|---|---|---|
| Right heart catheterizationAll groups were detected with SW catheter by the internal jugular vein before the procedure. After the measurement, the catheter was indwelled, and the pacemaker implantation procedure was started. After ventricular pacing for 5 minutes, the SW catheter measurement was performed again. After the measurement, the SW catheter was withdrawn. | Procedure or surgery | His bundle pacing group, Left branch bundle pacing group, Right ventricular pacing group |
Primary outcome
Incidence of adverse events after procedure
Time frame: From date of inclusion until the date of documented adverse events, assessed up to 1 year
rehospitalization due to acute heart failure, all-cause mortality, cardiac death
12 secondary outcomes
Changes in systolic, diastolic and mean pulmonary artery pressure by Swan-Ganz catheter from pre-procedure level
Time frame: 5 minutes after ventricular pacing lead implantation
Changes in systolic, diastolic and mean right ventricular pressure by Swan-Ganz catheter from pre-procedure level
Time frame: 5 minutes after ventricular pacing lead implantation
Changes in systolic, diastolic and mean right atrial pressure by Swan-Ganz catheter from pre-procedure level
Time frame: 5 minutes after ventricular pacing lead implantation
Changes in right ventricular global longitudinal strain rate from pre-porcedure level
Time frame: 24 hours post procedure, 1st month, 3rd month, 12th month since procedure
Changes in tricuspid annular plane systolic excursion from pre-procedure level
Time frame: 24 hours post procedure, 1st month, 3rd month, 12th month since procedure
Changes in Tei index from pre-procedure level
Time frame: 24 hours post procedure, 1st month, 3rd month, 12th month since procedure
Changes in pulmonary artery systolic pressure by echocardiography from pre-procedure level
Time frame: 24 hours post procedure, 1st month, 3rd month, 12th month since procedure
Change from baseline walking distance of 6-min walk test between different groups at 6 month after procedure
Time frame: 1st month, 3rd month, 12th month since procedure
Change from baseline general quality of life evaluation
Time frame: 1st month, 3rd month, 12th month since procedure
Change from baseline heart failure-specific quality of life evaluation
Time frame: 1st month, 3rd month, 12th month since procedure
Change in heart failure biomarker from baseline
Time frame: 1st month, 3rd month, 12th month since procedure
Changes in blood pressure from baseline between different groups at 6 months after procedure
Time frame: 1st month, 3rd month, 12th month since procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Derived from this study: PubMed 42886112Su Y, Xu X, Xie D, Ren Z, Tang K, Li H, Zhang J, Wu S, Sun H, Xu Y, Li Y, Zhao D, Che W. PCWP Characterizes Responders of Left Bundle Branch Area Pacing in HFpEF Population. JACC Asia. 2026 Oct 14:S2772-3747(26)00789-1. doi: 10.1016/j.jacasi.2026.08.030. Online ahead of print.
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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.
Yawei Xu principal investigator
Shanghai 10th People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Right heart catheterization in people with Heart Failure With Reduced Ejection Fraction and Atrial Fibrillation, Persistent, run by Shanghai 10th People's 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Su (+86 13817491747, suyang-yiyi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events after procedure (time frame: From date of inclusion until the date of documented adverse events, assessed up to 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 NCT05575557, which also lists 1 linked publication.
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 29 Dec 2022.