Heart FailureNCT04505384
Acute Effects of LBBP Versus BVP for CRT
A study testing left bundle branch pacing and biventricular pacing in people with Heart Failure and Cardiac Pacing, Artificial, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The study was designed to compare the acute effects of left bundle branch pacing (LBBP) with biventricular pacing (BVP) in patients with left ventricular ejection fraction (LVEF) <=35% with left bundle branch block (LBBB). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure, Cardiac Pacing, Artificial, Cardiac Resynchronization Therapy
- What is being tested?
- left bundle branch pacing and biventricular pacing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 31 Dec 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NYHA class II-IV;
- LVEF <=35%;
- LBBB with QRS duration >=130ms.
Who cannot join
- moderate-to-severe aortic stenosis;
- frequent premature ventricular complexes;
- significant peripheral vascular disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of Left Bundle Branch Pacing Versus Biventricular Pacing for Cardiac Resynchronization Therapy
The study was designed to compare the acute effects of left bundle branch pacing (LBBP) with biventricular pacing (BVP) in patients with left ventricular ejection fraction (LVEF) <=35% with left bundle branch block (LBBB).
Read the detailed description
The metrics include electrocardiographic, echocardiographic and hemodynamic parameters to evaluate and compare LBBP with BVP for resynchronization therapy in patients with heart failure and LBBB.
- Being tested
- left bundle branch 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.
left bundle branch pacingProcedure or surgery
left bundle branch pacing
biventricular pacingProcedure or surgery
biventricular pacing
| Study group | Role | What they receive |
|---|---|---|
| Left bundle branch pacing | Experimental | Left bundle branch pacing Receives: Procedure: left bundle branch pacing |
| Biventricular pacing | Active comparator | Biventricular pacing Receives: Procedure: biventricular pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic parameter LV dP/dt(max)
LV dP/dt(max) will be obtained during implant procedure.
Measured: 1 hour
Secondary outcomes (2)
Electrical synchrony parameters including QRS duration and QRS area
Acquired from EP system during procedure
Measured: 0.5 hour
Mechanical parameters including Ts-SD and IVMD
Acquired by an echocardiologist during procedure
Measured: 0.5 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start1 Sep 2020
- Primary completion30 Sep 2021
- Study completion31 Dec 2021
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
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yangang Su, MD, Study chair, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505384
- Sponsor's protocol ID
- ZS-LBBPvsBVP
- Status last verified
- Jan 2022
- First submitted
- 31 Jul 2020
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liang Y, Wang J, Gong X, Lu H, Yu Z, Zhang L, Li M, Pan L, Chen X, Cui J, Zhang W, Li R, Zhou X, Huang W, Su Y, Ge J. Left Bundle Branch Pacing Versus Biventricular Pacing for Acute Cardiac Resynchronization in Patients With Heart Failure. Circ Arrhythm Electrophysiol. 2022 Nov;15(11):e011181. doi: 10.1161/CIRCEP.122.011181. Epub 2022 Oct 28.
PubMed 36306335
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Left Bundle Branch Pacing Versus Biventricular Pacing for Cardiac Resynchronization Therapy
- ClinicalTrials.gov ID
- NCT04505384
- Acronym / sponsor ID
- ZS-LBBPvsBVP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 10 Aug 2020 (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 study was designed to compare the acute effects of left bundle branch pacing (LBBP) with biventricular pacing (BVP) in patients with left ventricular ejection fraction (LVEF) <=35% with left bundle branch block (LBBB).
Detailed description
The metrics include electrocardiographic, echocardiographic and hemodynamic parameters to evaluate and compare LBBP with BVP for resynchronization therapy in patients with heart failure and LBBB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left bundle branch pacing | Experimental | Procedure: left bundle branch pacingLeft bundle branch pacing |
| Biventricular pacing | Active comparator | Procedure: biventricular pacingBiventricular pacing |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- NYHA class II-IV;
- LVEF <=35%;
- LBBB with QRS duration >=130ms.
Key exclusion criteria (3 listed)
- moderate-to-severe aortic stenosis;
- frequent premature ventricular complexes;
- 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 |
|---|---|---|
| left bundle branch pacingleft bundle branch pacing | Procedure or surgery | Left bundle branch pacing |
| biventricular pacingbiventricular pacing | Procedure or surgery | Biventricular pacing |
Primary outcome
Hemodynamic parameter LV dP/dt(max)
Time frame: 1 hour
LV dP/dt(max) will be obtained during implant procedure.
2 secondary outcomes
Electrical synchrony parameters including QRS duration and QRS area
Time frame: 0.5 hour
Mechanical parameters including Ts-SD and IVMD
Time frame: 0.5 hour
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 20 Jan 2022.
- Derived from this study: PubMed 36306335Liang Y, Wang J, Gong X, Lu H, Yu Z, Zhang L, Li M, Pan L, Chen X, Cui J, Zhang W, Li R, Zhou X, Huang W, Su Y, Ge J. Left Bundle Branch Pacing Versus Biventricular Pacing for Acute Cardiac Resynchronization in Patients With Heart Failure. Circ Arrhythm Electrophysiol. 2022 Nov;15(11):e011181. doi: 10.1161/CIRCEP.122.011181. Epub 2022 Oct 28.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
Yangang Su, MD study chair
Shanghai Zhongshan 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 left bundle branch pacing and biventricular pacing in people with Heart Failure and Cardiac Pacing, Artificial, 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 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: finished, as of the sponsor's last update on 20 Jan 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?
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?
Hemodynamic parameter LV dP/dt(max) (time frame: 1 hour). 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 NCT04505384, 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 20 Jan 2022.