Heart FailureNCT07032064
Evaluation of Electrical and Hemodynamic Effects of Different Pacing Strategies in CRT Candidates
A study testing Sequential ventricular pacing at five sites in people with Heart Failure and CRT and/or ICD, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Heart failure patients with delayed electrical activation of the heart often benefit from cardiac resynchronization therapy (CRT). However, traditional CRT using biventricular pacing is not effective in all patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure, CRT and/or ICD
- What is being tested?
- Sequential ventricular pacing at five sites
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 3 Jun 2024to 20 May 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- NYHA class I to ambulatory IV despite optimized medical therapy for ≥3 months, LVEF ≤35%, and sinus rhythm with LBBB. LBBB was defined as QRS duration ≥130 ms, QS or rS in lead V1, broad/notched R waves in leads I, aVL, V5-V6, and absence of q waves in V5-V6
Who cannot join
- second- or third-degree AV block, frequent PVCs, moderate-to-severe aortic stenosis, LV thrombus, or significant peripheral vascular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electrical and Hemodynamic Assessment of Pacing Modalities in Patients With Indications for Cardiac Resynchronization Therapy
Heart failure patients with delayed electrical activation of the heart often benefit from cardiac resynchronization therapy (CRT). However, traditional CRT using biventricular pacing is not effective in all patients. This study aims to evaluate the acute effects of pacing at different sites within the heart's conduction system-including His bundle pacing, deep septal pacing, left ventricular septal pacing, non-selective left bundle branch pacing, and selective left bundle branch pacing.
We will assess how these pacing strategies improve electrical synchrony and heart function by analyzing ECG parameters, such as QRS duration and QRS area, and measuring hemodynamic response using left ventricular pressure changes. The goal is to identify which pacing site provides the best improvement in heart performance. The study includes patients with left bundle branch block or intraventricular conduction delay, reduced heart function (ejection fraction <35%), and prolonged QRS duration (>150 ms).
This research may help improve the effectiveness of pacing therapy in heart failure patients who are not responding well to current CRT methods.
Read the detailed description
This is a prospective, single-center, crossover study designed to evaluate the acute hemodynamic and electrical effects of pacing at five distinct sites within the conduction system in patients with heart failure and wide QRS complexes. Each participant will undergo temporary pacing at the His bundle, deep septal, left ventricular septal, non-selective left bundle branch, and selective left bundle branch sites.
Pacing sites will be confirmed by fluoroscopic guidance and intracardiac electrogram criteria, including stimulus-to-R' interval and QRS morphology. Hemodynamic response during each pacing mode will be assessed non-invasively using a Finometer device, which continuously measures beat-to-beat blood pressure and provides derived parameters of cardiac function.
The primary objective is to compare the relative hemodynamic benefits and electrical synchrony achieved at each pacing location, with the aim of optimizing lead placement strategies for conduction system pacing in heart failure patients.
- Conditions
- Heart Failure, CRT and/or ICD
- Being tested
- Sequential ventricular pacing at five sites
- Keywords
- Cardiac resynchronization therapy;, Cardiac physiologic pacing；, Heart failure, Left bundle branch area pacing, Electrical resynchronization, Hemodynamic assessment
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequential ventricular pacing at five sitesProcedure or surgery
This intervention involves sequential temporary pacing at five distinct ventricular sites within the same patient during a single electrophysiological study. The pacing sites include:His bundle pacing (HBP),Deep septal pacing (DSP),Left ventricular septal pacing (LVSP),Non-selective left bundle branch pacing (NS-LBBP),Selective left bundle branch pacing (SLBBP).
Each pacing modality is tested under identical hemodynamic and electrophysiological conditions using a fixed output and AV delay. Electrical parameters and acute hemodynamic responses are recorded for each site. The study uses a within-subject crossover design, allowing direct intra-individual comparison of different pacing strategies in patients meeting standard CRT indications. No long-term device implantation is involved during this phase of the study.
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of five pacing strategies in a Single-Arm CRT candidate cohort | Experimental | All enrolled patients will undergo sequential pacing at five ventricular sites during a single procedure: His bundle pacing (HBP), deep septal pacing (DSP), left ventricular septal pacing (LVSP), non-selective left bundle branch pacing (NS-LBBP), and selective left bundle branch pacing (SLBBP). Each pacing mode will be tested under identical physiological conditions in the same individual, and electrical and hemodynamic parameters will be recorded for comparative analysis. The order of pacing may be randomized or standardized according to protocol. Receives: Procedure: Sequential ventricular pacing at five sites |
What is being measured
The primary outcome is the main question the study is designed to answer.
QRSd
QRSd was measured from the onset to the end of the QRS complex
Measured: within 30 minutes per patient
QRSa
QRSa was computed as the sum of the QRS area across three orthogonal vectorcardiographic leads reconstructed using the Kors transformation matrices
Measured: within 30 minutes per patient
Hemodynamic Evaluation
Continuous non-invasive blood pressure was monitored using a Finometer device
Measured: within 30 minutes per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start3 Jun 2024
- Primary completion20 May 2025
- Study completion20 May 2025
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 FailureStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yixiu Liang, Shanghai Zhongshan Hospital
- Investigators
- Yixiu Liang, M.D., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032064
- Sponsor's protocol ID
- CPP-Electro-Hemo
- Status last verified
- Jun 2025
- First submitted
- 13 Jun 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
Su Y, Yu Z, Xiao Z, Pan L, Lu H, Chen J, Li M, Li X, Arnold AD, Whinnett ZI, Liang Y, Su Y. Evaluation of Acute Electrical and Hemodynamic Improvement During Left Bundle-Branch Area Pacing Modalities for Resynchronization Therapy. J Am Heart Assoc. 2026 Oct 23:e049208. doi: 10.1161/JAHA.126.049208. Online ahead of print.
PubMed 42924745
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical and Hemodynamic Assessment of Pacing Modalities in Patients With Indications for Cardiac Resynchronization Therapy
- ClinicalTrials.gov ID
- NCT07032064
- Acronym / sponsor ID
- CPP-Electro-Hemo
- Conditions
- Heart Failure, CRT and/or ICD
- Keywords
- Cardiac resynchronization therapy;, Cardiac physiologic pacing；, Heart failure, Left bundle branch area pacing, Electrical resynchronization, Hemodynamic assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 22 Jun 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.
Heart failure patients with delayed electrical activation of the heart often benefit from cardiac resynchronization therapy (CRT). However, traditional CRT using biventricular pacing is not effective in all patients. This study aims to evaluate the acute effects of pacing at different sites within the heart's conduction system-including His bundle pacing, deep septal pacing, left ventricular septal pacing, non-selective left bundle branch pacing, and selective left bundle branch pacing.
We will assess how these pacing strategies improve electrical synchrony and heart function by analyzing ECG parameters, such as QRS duration and QRS area, and measuring hemodynamic response using left ventricular pressure changes. The goal is to identify which pacing site provides the best improvement in heart performance. The study includes patients with left bundle branch block or intraventricular conduction delay, reduced heart function (ejection fraction <35%), and prolonged QRS duration (>150 ms).
This research may help improve the effectiveness of pacing therapy in heart failure patients who are not responding well to current CRT methods.
Detailed description
This is a prospective, single-center, crossover study designed to evaluate the acute hemodynamic and electrical effects of pacing at five distinct sites within the conduction system in patients with heart failure and wide QRS complexes. Each participant will undergo temporary pacing at the His bundle, deep septal, left ventricular septal, non-selective left bundle branch, and selective left bundle branch sites.
Pacing sites will be confirmed by fluoroscopic guidance and intracardiac electrogram criteria, including stimulus-to-R' interval and QRS morphology. Hemodynamic response during each pacing mode will be assessed non-invasively using a Finometer device, which continuously measures beat-to-beat blood pressure and provides derived parameters of cardiac function.
The primary objective is to compare the relative hemodynamic benefits and electrical synchrony achieved at each pacing location, with the aim of optimizing lead placement strategies for conduction system pacing in heart failure patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of five pacing strategies in a Single-Arm CRT candidate cohort | Experimental | Procedure: Sequential ventricular pacing at five sitesAll enrolled patients will undergo sequential pacing at five ventricular sites during a single procedure: His bundle pacing (HBP), deep septal pacing (DSP), left ventricular septal pacing (LVSP), non-selective left bundle branch pacing (NS-LBBP), and selective left bundle branch pacing (SLBBP). Each pacing mode will be tested under identical physiological conditions in the same individual, and electrical and hemodynamic parameters will be recorded for comparative analysis. The order of pacing may be randomized or standardized according to protocol. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- NYHA class I to ambulatory IV despite optimized medical therapy for ≥3 months, LVEF ≤35%, and sinus rhythm with LBBB. LBBB was defined as QRS duration ≥130 ms, QS or rS in lead V1, broad/notched R waves in leads I, aVL, V5-V6, and absence of q waves in V5-V6
Key exclusion criteria (1 listed)
- second- or third-degree AV block, frequent PVCs, moderate-to-severe aortic stenosis, LV thrombus, or significant peripheral vascular disease
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 |
|---|---|---|
| Sequential ventricular pacing at five sitesThis intervention involves sequential temporary pacing at five distinct ventricular sites within the same patient during a single electrophysiological study. The pacing sites include:His bundle pacing (HBP),Deep septal pacing (DSP),Left ventricular septal pacing (LVSP),Non-selective left bundle branch pacing (NS-LBBP),Selective left bundle branch pacing (SLBBP). Each pacing modality is tested under identical hemodynamic and electrophysiological conditions using a fixed output and AV delay. Electrical parameters and acute hemodynamic responses are recorded for each site. The study uses a within-subject crossover design, allowing direct intra-individual comparison of different pacing strategies in patients meeting standard CRT indications. No long-term device implantation is involved during this phase of the study. | Procedure or surgery | Evaluation of five pacing strategies in a Single-Arm CRT candidate cohort |
Primary outcome
QRSd
Time frame: within 30 minutes per patient
QRSd was measured from the onset to the end of the QRS complex
QRSa
Time frame: within 30 minutes per patient
QRSa was computed as the sum of the QRS area across three orthogonal vectorcardiographic leads reconstructed using the Kors transformation matrices
Hemodynamic Evaluation
Time frame: within 30 minutes per patient
Continuous non-invasive blood pressure was monitored using a Finometer device
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Derived from this study: PubMed 42924745Su Y, Yu Z, Xiao Z, Pan L, Lu H, Chen J, Li M, Li X, Arnold AD, Whinnett ZI, Liang Y, Su Y. Evaluation of Acute Electrical and Hemodynamic Improvement During Left Bundle-Branch Area Pacing Modalities for Resynchronization Therapy. J Am Heart Assoc. 2026 Oct 23:e049208. doi: 10.1161/JAHA.126.049208. Online ahead of print.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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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.
Yixiu Liang, M.D. principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sequential ventricular pacing at five sites in people with Heart Failure and CRT and/or ICD, run by Shanghai Zhongshan 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 22 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
QRSd (time frame: within 30 minutes per patient). The study lists 3 primary outcomes in all. 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 NCT07032064, 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 22 Jun 2025.