Atrioventricular Block, Second and Third DegreeNCT05553626
Safety and Effectiveness of Left Bundle Branch Pacing in Patients With Cardiac Dysfunction and AV Block
A study testing Left bundle branch pacing and Bi-ventricular pacing in people with Atrioventricular Block, Second and Third Degree and Heart Failure, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
This study is a multicenter, prospective, randomized study to assess if cardiac dysfunction patients with LVEF <50% and the estimated ventricular pacing percentage >40% with LBBP have the non-inferior safety and efficacy than CRT on patients' cardiac function and prognosis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrioventricular Block, Second and Third Degree, Heart Failure, Left Bundle Branch Pacing
- What is being tested?
- Left bundle branch pacing and Bi-ventricular pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Sep 2022to Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Above 18 years old
- Agree to participate in trial and sign informed consent
- NYHA cardiac function class I-III
- LVEF<50%
- Second or complete atrioventricular block with pacing indication or ventricular pacing dependent with ventricular pacing percentage >40%
- Patients who are willing to take the de-novo implant or device replacement or upgrade.
Who cannot join
- Life expectancy <1 year
- Patients with severe tricuspid valvular disease1 or who have undergone mechanical valve or bioprosthetic valve surgery
- Acute myocardial infarction within 1 month
- Women of childbearing age who are pregnant or becoming pregnant during the study period
- Severe liver and kidney dysfunction2
- Have been enrolled in another clinical studies that may interferes with the current trial objectives
Show all 9Show fewer
- Evidence of severe pulmonary hypertension (PASP>70mmHg)
- Evidence of hypertrophic cardiomyopathy which shall affect the prognosis of patients.
- The investigator believes that subject's physical condition is not suitable for participation in the trial
Trial locations and contacts
1 site in 1 country.
China1 site
First Affliated Hospital, Wenzhou Medical University
Wenzhou, Zhejiang, 325000
About this study
Official title: Safety and Effectiveness of Left Bundle Branch Pacing (LBBP) in Patients With Cardiac Dysfunction and AV Block
This study is a multicenter, prospective, randomized study to assess if cardiac dysfunction patients with LVEF <50% and the estimated ventricular pacing percentage >40% with LBBP have the non-inferior safety and efficacy than CRT on patients' cardiac function and prognosis
Read the detailed description
Patients who meet the inclusion and exclusion criteria will be enrolled into the study. In the study, patients with cardiac dysfunction who met the enrollment criteria and will agree to participate in this trial will be 1:1 randomized to the LBBP group and the CRT group. Patients who were successfully implanted were enrolled for evaluation and follow-up. The primary end points of the study is the change of LVEF within 12 months post-implant in both LBBP Treatment Group and CRT Treatment Group
- Being tested
- Left bundle branch pacing, Bi-ventricular pacing
- Keywords
- pacing induced cardiomyopathy, heart failure, pacing, LBBP, BVP, RVP, conduction system pacing, cardiac Resynchronization Therapy, bradycardiac arrhythmia
- Medical subject headings
- Atrioventricular Block, Neoplasm Metastasis, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left bundle branch pacingDevice
Left bundle branch pacing by a single/dual chamber pacemaker or dual chamber ICD device through the pacing lead at left bundle branch region
Bi-ventricular pacingDevice
Bi-ventricular pacing by a CRT/CRTD device
| Study group | Role | What they receive |
|---|---|---|
| LBBP Treatment | Experimental | Patients were performed left bundle branch pacing by a single/dual chamber pacemaker or dual chamber ICD device Receives: Device: Left bundle branch pacing; Device: Bi-ventricular pacing |
| BVP Treatment | Active comparator | Patients were performed bi-ventricular pacing by a CRT/CRTD device Receives: Device: Left bundle branch pacing; Device: Bi-ventricular pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of LVEF
To compare the effects of LBBP Treatment Group and CRT Treatment Group on target subjects by analyzing the LVEF within 12 months post-implant.
Measured: 12 months
Secondary outcomes (6)
Change of LVESV
To demonstrate and compare the LVESV at 12 month post-implant.
Measured: 12 months
successful rate
To characterize the successful rate of LBBP Procedure and CRT Procedure among randomized patients' group.
Measured: 12 months
mortality and heart failure hospitalization rate
To demonstrate and compare the mortality and heart failure hospitalization rate between LBBP and CRT treatment group 12 month post-implant
Measured: 12 months
occurrence of serious complication associated with LBBP procedure
To characterize occurrence of serious complication associated with LBBP procedure within 12 month post-implant.
Measured: 12 months
QRS width between LBBP and CRT
To characterize and compare the QRS width between LBBP and CRT treatment groups during the baseline, preoperative, postoperative and follow up visits within 3 months and 12 month post-implant.
Measured: 12 months
incidence and severity of tricuspid regurgitation
To assess and compare the incidence and severity of tricuspid regurgitation between LBBP and CRT treatment groups within 12 month post-implant
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study startSep 2022 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrioventricular Block, Second and Third DegreeStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Wenzhou 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital, Sir Run Run Shaw Hospital, The First Affiliated Hospital of Dalian Medical University, Shanxi Cardiovascular Hospital, Shanghai 10th People's Hospital, The Second Affiliated Hospital of Harbin Medical University, The First People's Hospital of Yunnan, Shanghai Zhongshan Hospital, Shenzhen Sun Yat-sen Cardiovascular Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Second Affiliated Hospital of Nanchang University, Tianjin Chest Hospital, Xiamen Cardiovascular Hospital, Xiamen University, Yan'an Affiliated Hospital of Kunming Medical University, Shanghai Chest Hospital, Medtronic (Shanghai) Management Co. Ltd.
- Responsible party
- Sponsor
- Investigators
- Weijian Huang, MD, Principal investigator, Wenzhou 1st Affliated Hopsital, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553626
- Sponsor's protocol ID
- FirstWenzhouMU216-02
- Status last verified
- Jul 2022
- First submitted
- 21 Sep 2022
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Left Bundle Branch Pacing (LBBP) in Patients With Cardiac Dysfunction and AV Block
- ClinicalTrials.gov ID
- NCT05553626
- Acronym / sponsor ID
- FirstWenzhouMU216-02
- Keywords
- pacing induced cardiomyopathy, heart failure, pacing, LBBP, BVP, RVP, conduction system pacing, cardiac Resynchronization Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital, Sir Run Run Shaw Hospital, The First Affiliated Hospital of Dalian Medical University, Shanxi Cardiovascular Hospital, Shanghai 10th People's Hospital, The Second Affiliated Hospital of Harbin Medical University, The First People's Hospital of Yunnan, Shanghai Zhongshan Hospital, Shenzhen Sun Yat-sen Cardiovascular Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Second Affiliated Hospital of Nanchang University, Tianjin Chest Hospital, Xiamen Cardiovascular Hospital, Xiamen University, Yan'an Affiliated Hospital of Kunming Medical University, Shanghai Chest Hospital, Medtronic (Shanghai) Management Co. Ltd.
- Study start
- Sep 2022 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 23 Sep 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.
This study is a multicenter, prospective, randomized study to assess if cardiac dysfunction patients with LVEF <50% and the estimated ventricular pacing percentage >40% with LBBP have the non-inferior safety and efficacy than CRT on patients' cardiac function and prognosis
Detailed description
Patients who meet the inclusion and exclusion criteria will be enrolled into the study. In the study, patients with cardiac dysfunction who met the enrollment criteria and will agree to participate in this trial will be 1:1 randomized to the LBBP group and the CRT group. Patients who were successfully implanted were enrolled for evaluation and follow-up. The primary end points of the study is the change of LVEF within 12 months post-implant in both LBBP Treatment Group and CRT Treatment Group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LBBP Treatment | Experimental | Device: Left bundle branch pacing, Device: Bi-ventricular pacingPatients were performed left bundle branch pacing by a single/dual chamber pacemaker or dual chamber ICD device |
| BVP Treatment | Active comparator | Device: Left bundle branch pacing, Device: Bi-ventricular pacingPatients were performed bi-ventricular pacing by a CRT/CRTD device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Above 18 years old
- Agree to participate in trial and sign informed consent
- NYHA cardiac function class I-III
- LVEF<50%
- Second or complete atrioventricular block with pacing indication or ventricular pacing dependent with ventricular pacing percentage >40%
Key exclusion criteria (9 listed)
- Life expectancy <1 year
- Patients with severe tricuspid valvular disease1 or who have undergone mechanical valve or bioprosthetic valve surgery
- Acute myocardial infarction within 1 month
- Women of childbearing age who are pregnant or becoming pregnant during the study period
- Severe liver and kidney dysfunction2
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 by a single/dual chamber pacemaker or dual chamber ICD device through the pacing lead at left bundle branch region | Device | BVP Treatment, LBBP Treatment |
| Bi-ventricular pacingBi-ventricular pacing by a CRT/CRTD device | Device | BVP Treatment, LBBP Treatment |
Primary outcome
Change of LVEF
Time frame: 12 months
To compare the effects of LBBP Treatment Group and CRT Treatment Group on target subjects by analyzing the LVEF within 12 months post-implant.
6 secondary outcomes
Change of LVESV
Time frame: 12 months
successful rate
Time frame: 12 months
mortality and heart failure hospitalization rate
Time frame: 12 months
occurrence of serious complication associated with LBBP procedure
Time frame: 12 months
QRS width between LBBP and CRT
Time frame: 12 months
incidence and severity of tricuspid regurgitation
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- 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. This study is not recruiting at the moment.
Weijian Huang, MD principal investigator
Wenzhou 1st Affliated Hopsital, Wenzhou Medical 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 Left bundle branch pacing and Bi-ventricular pacing in people with Atrioventricular Block, Second and Third Degree and Heart Failure, run by First Affiliated Hospital of Wenzhou 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 9 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 23 Sep 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 Weijian Huang, MD (+86138-0669-1086, weijianhuang69@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of LVEF (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2022; AzTrials last refreshed its copy on 7 Nov 2026.