Conduction System PacingCSP-UPGRADENCT06241651
CSP Versus BiVP for Heart Failure Patients With RVP Upgraded to Cardiac Resynchronization Therapy
A study testing Conduction system pacing and Biventricular pacing in people with Conduction System Pacing and Biventricular Pacing, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The present study is a prospective, multicenter, non-inferiority, randomized controlled trail. It aims to investigate whether the efficacy of conduction system pacing (CSP) is non-inferior to biventricular pacing (BiVP) in patients with heart failure and right ventricular pacing (RVP) requiring upgrading to cardiac… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Conduction System Pacing, Biventricular Pacing, Cardiac Resynchronization Therapy
- What is being tested?
- Conduction system pacing and Biventricular pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to Mar 2027
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with symptomatic heart failure (LVEF <50%) after right ventricular pacing for at least 3 months;
- NYHA class II-IV;
- NT-proBNP >125pg/mL in patients with sinus rhythm, NT-proBNP >250pg/mL in patients with atrial fibrillation;
- Right ventricular pacing percentage >40%;
- Adult patients aged 18-80;
- With informed consent signed.
Who cannot join
- History of acute myocardial infarction within 3 months before enrollment;
- Frequent premature ventricular contraction (>15%) or malignant ventricular arrhythmia which is difficult to control;
- History of valvular heart disease intervention within 3 months before enrollment;
- After mechanical tricuspid valve replacement;
- Ventricular septal hypertrophy (≥15mm during diastole);
- Complex congenital heart disease;
Show all 10Show fewer
- History of heart transplantation;
- Enrollment in any other study;
- Pregnant or with child-bearing plan;
- A life expectancy of less than 12 months.
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 with Nanjing Medical University
Nanjing, Jiangsu, 210029
Jiangang Zou, 86-13605191407, jgzou@njmu.edu.cn
About this study
Official title: Conduction System Pacing Versus Biventricular Pacing for Heart Failure Patients With Right Ventricular Pacing Upgraded to Cardiac Resynchronization Therapy: a Prospective Multicenter Non-inferiority Randomized Controlled Study
The present study is a prospective, multicenter, non-inferiority, randomized controlled trail. It aims to investigate whether the efficacy of conduction system pacing (CSP) is non-inferior to biventricular pacing (BiVP) in patients with heart failure and right ventricular pacing (RVP) requiring upgrading to cardiac resynchronization therapy (CRT).
Read the detailed description
RVP is a standardized treatment strategy for severe bradyarrhythmia. However, RVP can result in electrical and mechanical dyssynchrony of the heart, which will adversely affect cardiac function. Until now, many studies have shown that RVP can promote the progression of heart failure, especially in patients with high ventricular pacing percentage. For these heart failure patients, upgrading to CRT is a feasible and effective therapy.
BiVP is a traditional method to achieve CRT, which can improve cardiac synchrony and provide great clinical outcomes for heart failure patients upgraded from RVP. CSP contains left bundle branch pacing (LBBP) and His bundle pacing (HBP), which is able to activate native His-Purkinje conduction system and solve the problems caused by RVP. Although HBP has high technical requirements, lower sense value and higher threshold, it is the pacing modality closest to physiological conditions so far. Since first reported by Huang et al. in 2017, LBBP has been carried out boomingly all over the world. LBBP has been reported to offer higher success rate with higher sense value and lower pacing thresholds compared with HBP, which can also achieve similar electrical and mechanical resynchronization as well as HBP.
However, no randomized controlled studies have been reported to compare the efficacy of CSP and BiVP in patients with heart failure and RVP requiring upgrading to CRT. CSP-UPGRADE is a non-inferiority study, and the purpose of which is to investigate whether the efficacy of CSP is not inferior to BiVP in such patients. Eligible patients will be 1:1 randomized to two groups. The primary outcome is change in LVEF between baseline and six months after device implantation assessed by echocardiography. According to BUDAPEST-CRT Upgrade trial, half of lower limit of the 95% confidence interval for difference in mean ΔLVEF between the CRTD and ICD group is about 3.8%, which is used as non-inferiority margin in the present study. Based on previous studies and cases, it is assumed that the mean ΔLVEF values in patients upgraded to CSP and BiVP are equal and the standard deviations are both 5%. With power as 80%, alpha as 0.025, rate of lost-of-follow-up as 10%, the final sample size was estimated as 66 by using PASS Version 21.0.3 (33 patients for each group). If the non-inferiority test reaches positive results, then we will further verify whether CSP is superior to BiVP in such patients.
- Conditions
- Conduction System Pacing, Biventricular Pacing, Cardiac Resynchronization Therapy, Right Ventricular Pacing, Heart Failure
- Being tested
- Conduction system pacing, Biventricular pacing
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conduction system pacingDevice
Firstly, we will attempt LBBP if the patient is allocated to the experimental group. If we can not achieve LBBP successfully, then we will turn to attempt HBP.
Biventricular pacingDevice
Implantation of RA lead, RV lead and LV lead are attempted using the standard-of-care technique.
| Study group | Role | What they receive |
|---|---|---|
| CSP group | Experimental | In this group, CSP lead is attempted to be placed, including LBBP and HBP. Receives: Device: Conduction system pacing |
| BiVP group | Active comparator | In this group, traditional RA lead , RV lead and LV lead are attempted to be placed. Receives: Device: Biventricular pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
ΔLVEF
Change in LVEF between baseline and six months after device implantation
Measured: Baseline; 6-month follow-up
Secondary outcomes (14)
ΔLVEDD
Change in LVEDD between baseline and follow-up
Measured: Baseline; 3-month follow-up; 6-month follow-up
ΔLVEDV
Change in LVEDV between baseline and follow-up
Measured: Baseline; 3-month follow-up; 6-month follow-up
ΔLVESV
Change in LVESV between baseline and follow-up
Measured: Baseline; 3-month follow-up; 6-month follow-up
Paced QRS duration
Paced QRS duration is evaluated before discharge and follow-up
Measured: 1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up
Echocardiographic response rate
The percentage of patients responding to CRT upgrade assessed by echocardiography
Measured: Baseline; 6-month follow-up
Changes in NT-proBNP
The changes of NT-proBNP between baseline and follow-up
Measured: Baseline; 3-month follow-up; 6-month follow-up
Changes in New York Heart Association Heart Function Classification
The higher the classification, the more severe the heart failure symptoms (four levels: I, II, III and IV)
Measured: Baseline; 1-month follow-up; 3-month follow-up; 6-month follow-up
Changes in 6-minute Walk Distance
Distance that a participant walk within 6 minutes
Measured: Baseline; 3-month, 6-month follow-up
Change in Quality Of Life Questionnaire score
Reflect the effect of heart failure on quality of life, and higher scores represent a worse outcome
Measured: Baseline; 3-month follow-up; 6-month follow-up
Incidence of clinical adverse events
Including all-cause mortality, cardiovascular mortality, heart failure hospitalization and malignant ventricular arrhythmia
Measured: 1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up
Procedure-related costs
Costs related to device implantation
Measured: 1 day before discharge
Estimated longevity of the device
The longevity of the device will be estimated during pacemaker test
Measured: 1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up
Pacing parameters
Number of atrial fibrillation and NSVT/VT
Measured: 1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up
Pacemaker related complications
Including but not limited to hemorrhage, pneumothorax, pericardial effusion, device-related infection and lead displacement
Measured: 1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start1 Jan 2024
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Conduction System PacingStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The First Affiliated Hospital of Soochow University, The Affiliated Hospital of Xuzhou Medical University, The Third Affiliated Hospital of Soochow University, Rugao People's Hospital, Nanfang Hospital, Southern Medical University, First Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Shantou Central Hospital, Meizhou People's Hospital, Changzhou Second People's Hospital affiliated with Nanjing Medical University, Zhangjiagang First People's Hospital, Huizhou Third People's Hospital, Guangzhou Medical University
- Responsible party
- Principal investigator, Jiangang Zou, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241651
- Sponsor's protocol ID
- 2023-SR-811
- Acronym
- CSP-UPGRADE
- Status last verified
- May 2026
- First submitted
- 19 Jan 2024
- Last updated
- 14 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Glikson M, Nielsen JC, Kronborg MB, Michowitz Y, Auricchio A, Barbash IM, Barrabes JA, Boriani G, Braunschweig F, Brignole M, Burri H, Coats AJS, Deharo JC, Delgado V, Diller GP, Israel CW, Keren A, Knops RE, Kotecha D, Leclercq C, Merkely B, Starck C, Thylen I, Tolosana JM; ESC Scientific Document Group. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J. 2021 Sep 14;42(35):3427-3520. doi: 10.1093/eurheartj/ehab364. No abstract available.
PubMed 34455430Chung MK, Patton KK, Lau CP, Dal Forno ARJ, Al-Khatib SM, Arora V, Birgersdotter-Green UM, Cha YM, Chung EH, Cronin EM, Curtis AB, Cygankiewicz I, Dandamudi G, Dubin AM, Ensch DP, Glotzer TV, Gold MR, Goldberger ZD, Gopinathannair R, Gorodeski EZ, Gutierrez A, Guzman JC, Huang W, Imrey PB, Indik JH, Karim S, Karpawich PP, Khaykin Y, Kiehl EL, Kron J, Kutyifa V, Link MS, Marine JE, Mullens W, Park SJ, Parkash R, Patete MF, Pathak RK, Perona CA, Rickard J, Schoenfeld MH, Seow SC, Shen WK, Shoda M, Singh JP, Slotwiner DJ, Sridhar ARM, Srivatsa UN, Stecker EC, Tanawuttiwat T, Tang WHW, Tapias CA, Tracy CM, Upadhyay GA, Varma N, Vernooy K, Vijayaraman P, Worsnick SA, Zareba W, Zeitler EP. 2023 HRS/APHRS/LAHRS guideline on cardiac physiologic pacing for the avoidance and mitigation of heart failure. Heart Rhythm. 2023 Sep;20(9):e17-e91. doi: 10.1016/j.hrthm.2023.03.1538. Epub 2023 May 20.
PubMed 37283271Tops LF, Schalij MJ, Bax JJ. The effects of right ventricular apical pacing on ventricular function and dyssynchrony implications for therapy. J Am Coll Cardiol. 2009 Aug 25;54(9):764-76. doi: 10.1016/j.jacc.2009.06.006.
PubMed 19695453Kaye GC, Linker NJ, Marwick TH, Pollock L, Graham L, Pouliot E, Poloniecki J, Gammage M; Protect-Pace trial investigators. Effect of right ventricular pacing lead site on left ventricular function in patients with high-grade atrioventricular block: results of the Protect-Pace study. Eur Heart J. 2015 Apr 7;36(14):856-62. doi: 10.1093/eurheartj/ehu304. Epub 2014 Sep 4.
PubMed 25189602Khurshid S, Obeng-Gyimah E, Supple GE, Schaller R, Lin D, Owens AT, Epstein AE, Dixit S, Marchlinski FE, Frankel DS. Reversal of Pacing-Induced Cardiomyopathy Following Cardiac Resynchronization Therapy. JACC Clin Electrophysiol. 2018 Feb;4(2):168-177. doi: 10.1016/j.jacep.2017.10.002. Epub 2017 Nov 15.
PubMed 29749933Shan P, Su L, Zhou X, Wu S, Xu L, Xiao F, Zhou X, Ellenbogen KA, Huang W. Beneficial effects of upgrading to His bundle pacing in chronically paced patients with left ventricular ejection fraction <50. Heart Rhythm. 2018 Mar;15(3):405-412. doi: 10.1016/j.hrthm.2017.10.031. Epub 2017 Nov 16.
PubMed 29081396Qian Z, Wang Y, Hou X, Qiu Y, Wu H, Zhou W, Zou J. Efficacy of upgrading to left bundle branch pacing in patients with heart failure after right ventricular pacing. Pacing Clin Electrophysiol. 2021 Mar;44(3):472-480. doi: 10.1111/pace.14147. Epub 2021 Jan 31.
PubMed 33372293Merkely B, Hatala R, Wranicz JK, Duray G, Foldesi C, Som Z, Nemeth M, Goscinska-Bis K, Geller L, Zima E, Osztheimer I, Molnar L, Karady J, Hindricks G, Goldenberg I, Klein H, Szigeti M, Solomon SD, Kutyifa V, Kovacs A, Kosztin A. Upgrade of right ventricular pacing to cardiac resynchronization therapy in heart failure: a randomized trial. Eur Heart J. 2023 Oct 21;44(40):4259-4269. doi: 10.1093/eurheartj/ehad591.
PubMed 37632437
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conduction System Pacing Versus Biventricular Pacing for Heart Failure Patients With Right Ventricular Pacing Upgraded to Cardiac Resynchronization Therapy: a Prospective Multicenter Non-inferiority Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06241651
- Acronym / sponsor ID
- CSP-UPGRADE / 2023-SR-811
- Conditions
- Conduction System Pacing, Biventricular Pacing, Cardiac Resynchronization Therapy, Right Ventricular Pacing, Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The First Affiliated Hospital of Soochow University, The Affiliated Hospital of Xuzhou Medical University, The Third Affiliated Hospital of Soochow University, Rugao People's Hospital, Nanfang Hospital, Southern Medical University, First Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Shantou Central Hospital, Meizhou People's Hospital, Changzhou Second People's Hospital affiliated with Nanjing Medical University, Zhangjiagang First People's Hospital, Huizhou Third People's Hospital, Guangzhou Medical University
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 5 Feb 2024 (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 present study is a prospective, multicenter, non-inferiority, randomized controlled trail. It aims to investigate whether the efficacy of conduction system pacing (CSP) is non-inferior to biventricular pacing (BiVP) in patients with heart failure and right ventricular pacing (RVP) requiring upgrading to cardiac resynchronization therapy (CRT).
Detailed description
RVP is a standardized treatment strategy for severe bradyarrhythmia. However, RVP can result in electrical and mechanical dyssynchrony of the heart, which will adversely affect cardiac function. Until now, many studies have shown that RVP can promote the progression of heart failure, especially in patients with high ventricular pacing percentage. For these heart failure patients, upgrading to CRT is a feasible and effective therapy.
BiVP is a traditional method to achieve CRT, which can improve cardiac synchrony and provide great clinical outcomes for heart failure patients upgraded from RVP. CSP contains left bundle branch pacing (LBBP) and His bundle pacing (HBP), which is able to activate native His-Purkinje conduction system and solve the problems caused by RVP. Although HBP has high technical requirements, lower sense value and higher threshold, it is the pacing modality closest to physiological conditions so far. Since first reported by Huang et al. in 2017, LBBP has been carried out boomingly all over the world. LBBP has been reported to offer higher success rate with higher sense value and lower pacing thresholds compared with HBP, which can also achieve similar electrical and mechanical resynchronization as well as HBP.
However, no randomized controlled studies have been reported to compare the efficacy of CSP and BiVP in patients with heart failure and RVP requiring upgrading to CRT. CSP-UPGRADE is a non-inferiority study, and the purpose of which is to investigate whether the efficacy of CSP is not inferior to BiVP in such patients. Eligible patients will be 1:1 randomized to two groups. The primary outcome is change in LVEF between baseline and six months after device implantation assessed by echocardiography. According to BUDAPEST-CRT Upgrade trial, half of lower limit of the 95% confidence interval for difference in mean ΔLVEF between the CRTD and ICD group is about 3.8%, which is used as non-inferiority margin in the present study. Based on previous studies and cases, it is assumed that the mean ΔLVEF values in patients upgraded to CSP and BiVP are equal and the standard deviations are both 5%. With power as 80%, alpha as 0.025, rate of lost-of-follow-up as 10%, the final sample size was estimated as 66 by using PASS Version 21.0.3 (33 patients for each group). If the non-inferiority test reaches positive results, then we will further verify whether CSP is superior to BiVP in such patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSP group | Experimental | Device: Conduction system pacingIn this group, CSP lead is attempted to be placed, including LBBP and HBP. |
| BiVP group | Active comparator | Device: Biventricular pacingIn this group, traditional RA lead , RV lead and LV lead are attempted to be placed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with symptomatic heart failure (LVEF <50%) after right ventricular pacing for at least 3 months;
- NYHA class II-IV;
- NT-proBNP >125pg/mL in patients with sinus rhythm, NT-proBNP >250pg/mL in patients with atrial fibrillation;
- Right ventricular pacing percentage >40%;
- Adult patients aged 18-80;
Key exclusion criteria (10 listed)
- History of acute myocardial infarction within 3 months before enrollment;
- Frequent premature ventricular contraction (>15%) or malignant ventricular arrhythmia which is difficult to control;
- History of valvular heart disease intervention within 3 months before enrollment;
- After mechanical tricuspid valve replacement;
- Ventricular septal hypertrophy (≥15mm during diastole);
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 |
|---|---|---|
| Conduction system pacingFirstly, we will attempt LBBP if the patient is allocated to the experimental group. If we can not achieve LBBP successfully, then we will turn to attempt HBP. | Device | CSP group |
| Biventricular pacingImplantation of RA lead, RV lead and LV lead are attempted using the standard-of-care technique. | Device | BiVP group |
Primary outcome
ΔLVEF
Time frame: Baseline; 6-month follow-up
Change in LVEF between baseline and six months after device implantation
14 secondary outcomes
ΔLVEDD
Time frame: Baseline; 3-month follow-up; 6-month follow-up
ΔLVEDV
Time frame: Baseline; 3-month follow-up; 6-month follow-up
ΔLVESV
Time frame: Baseline; 3-month follow-up; 6-month follow-up
Paced QRS duration
Time frame: 1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up
Echocardiographic response rate
Time frame: Baseline; 6-month follow-up
Changes in NT-proBNP
Time frame: Baseline; 3-month follow-up; 6-month follow-up
Changes in New York Heart Association Heart Function Classification
Time frame: Baseline; 1-month follow-up; 3-month follow-up; 6-month follow-up
Changes in 6-minute Walk Distance
Time frame: Baseline; 3-month, 6-month follow-up
Change in Quality Of Life Questionnaire score
Time frame: Baseline; 3-month follow-up; 6-month follow-up
Incidence of clinical adverse events
Time frame: 1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up
Procedure-related costs
Time frame: 1 day before discharge
Estimated longevity of the device
Time frame: 1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up
Pacing parameters
Time frame: 1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up
Pacemaker related complications
Time frame: 1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up
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 14 May 2026.
- Background: PubMed 34455430Glikson M, Nielsen JC, Kronborg MB, Michowitz Y, Auricchio A, Barbash IM, Barrabes JA, Boriani G, Braunschweig F, Brignole M, Burri H, Coats AJS, Deharo JC, Delgado V, Diller GP, Israel CW, Keren A, Knops RE, Kotecha D, Leclercq C, Merkely B, Starck C, Thylen I, Tolosana JM; ESC Scientific Document Group. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J. 2021 Sep 14;42(35):3427-3520. doi: 10.1093/eurheartj/ehab364. No abstract available.
- Background: PubMed 37283271Chung MK, Patton KK, Lau CP, Dal Forno ARJ, Al-Khatib SM, Arora V, Birgersdotter-Green UM, Cha YM, Chung EH, Cronin EM, Curtis AB, Cygankiewicz I, Dandamudi G, Dubin AM, Ensch DP, Glotzer TV, Gold MR, Goldberger ZD, Gopinathannair R, Gorodeski EZ, Gutierrez A, Guzman JC, Huang W, Imrey PB, Indik JH, Karim S, Karpawich PP, Khaykin Y, Kiehl EL, Kron J, Kutyifa V, Link MS, Marine JE, Mullens W, Park SJ, Parkash R, Patete MF, Pathak RK, Perona CA, Rickard J, Schoenfeld MH, Seow SC, Shen WK, Shoda M, Singh JP, Slotwiner DJ, Sridhar ARM, Srivatsa UN, Stecker EC, Tanawuttiwat T, Tang WHW, Tapias CA, Tracy CM, Upadhyay GA, Varma N, Vernooy K, Vijayaraman P, Worsnick SA, Zareba W, Zeitler EP. 2023 HRS/APHRS/LAHRS guideline on cardiac physiologic pacing for the avoidance and mitigation of heart failure. Heart Rhythm. 2023 Sep;20(9):e17-e91. doi: 10.1016/j.hrthm.2023.03.1538. Epub 2023 May 20.
- Background: PubMed 19695453Tops LF, Schalij MJ, Bax JJ. The effects of right ventricular apical pacing on ventricular function and dyssynchrony implications for therapy. J Am Coll Cardiol. 2009 Aug 25;54(9):764-76. doi: 10.1016/j.jacc.2009.06.006.
- Background: PubMed 25189602Kaye GC, Linker NJ, Marwick TH, Pollock L, Graham L, Pouliot E, Poloniecki J, Gammage M; Protect-Pace trial investigators. Effect of right ventricular pacing lead site on left ventricular function in patients with high-grade atrioventricular block: results of the Protect-Pace study. Eur Heart J. 2015 Apr 7;36(14):856-62. doi: 10.1093/eurheartj/ehu304. Epub 2014 Sep 4.
- Background: PubMed 29749933Khurshid S, Obeng-Gyimah E, Supple GE, Schaller R, Lin D, Owens AT, Epstein AE, Dixit S, Marchlinski FE, Frankel DS. Reversal of Pacing-Induced Cardiomyopathy Following Cardiac Resynchronization Therapy. JACC Clin Electrophysiol. 2018 Feb;4(2):168-177. doi: 10.1016/j.jacep.2017.10.002. Epub 2017 Nov 15.
- Background: PubMed 29081396Shan P, Su L, Zhou X, Wu S, Xu L, Xiao F, Zhou X, Ellenbogen KA, Huang W. Beneficial effects of upgrading to His bundle pacing in chronically paced patients with left ventricular ejection fraction <50. Heart Rhythm. 2018 Mar;15(3):405-412. doi: 10.1016/j.hrthm.2017.10.031. Epub 2017 Nov 16.
- Background: PubMed 33372293Qian Z, Wang Y, Hou X, Qiu Y, Wu H, Zhou W, Zou J. Efficacy of upgrading to left bundle branch pacing in patients with heart failure after right ventricular pacing. Pacing Clin Electrophysiol. 2021 Mar;44(3):472-480. doi: 10.1111/pace.14147. Epub 2021 Jan 31.
- Background: PubMed 37632437Merkely B, Hatala R, Wranicz JK, Duray G, Foldesi C, Som Z, Nemeth M, Goscinska-Bis K, Geller L, Zima E, Osztheimer I, Molnar L, Karady J, Hindricks G, Goldenberg I, Klein H, Szigeti M, Solomon SD, Kutyifa V, Kovacs A, Kosztin A. Upgrade of right ventricular pacing to cardiac resynchronization therapy in heart failure: a randomized trial. Eur Heart J. 2023 Oct 21;44(40):4259-4269. doi: 10.1093/eurheartj/ehad591.
- Individual participant dataSharing planned: No
Related trials for Conduction System Pacing
RecruitingObservational study
Leadless Pacemaker Registry: Outcomes and Follow-up From the University Hospital of St. Pölten
Pacemaker, Leadless Pacemaker
RecruitingObservational study
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
Arrhythmia, Bradycardia
Recruiting
Safety and Effectiveness of Left Bundle Branch Area Pacing Versus Conventional Cardiac Resynchronization Therapy in Heart Failure
Heart Failure - NYHA II - IV
Not yet recruiting
LBBAP Versus ILR in Patients With New-Onset LBBB and Moderately Reduced LVEF After TAVI
TAVI(Transcatheter Aortic Valve Implantation), Left Bundle Branch Block
Active, not recruitingObservational study
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
Bradycardia, Atrioventricular Block
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conduction system pacing and Biventricular pacing in people with Conduction System Pacing and Biventricular Pacing, run by The First Affiliated Hospital with Nanjing Medical University 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 6 inclusion and 10 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 14 May 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?
Contact Jiangang Zou (86-13605191407, jgzou@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ΔLVEF (time frame: Baseline; 6-month follow-up). 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 NCT06241651, which also lists 8 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 14 May 2026.