Atrioventricular BlockNCT03851315
Left Bundle Branch Area Pacing in AVB Patients
An observational study of Atrioventricular Block and Left Bundle Branch Area Pacing, run by Fu Wai Hospital, Beijing, China at 1 site in China.
Trial summary
Right ventricular pacing (RVP) causes left ventricular mechanical dyssynchrony by inducing electrical interventricular and intraventricular dyssynchrony. His bundle pacing may restore the the atrioventricular, interventricular and intraventricular electrical synchronization, however, Increased pacing threshold might… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrioventricular Block, Left Bundle Branch Area Pacing
- What is being tested?
- permanent left bundle branch area pacing
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 30 Jun 2021
- Phase
- Observational
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Consecutive AVB patients with indications for ventricular pacing according to 2013 ESC/EHRA Guidelines. Patients with persistent atrial fibrillation or indications for cardiac resynchronization therapy or implantable cardioverter defibrillator implantation , hypertrophic cardiomyopathy, myocardial amyloidosis, or refused postoperative follow-up were excluded. All patients should sign written informed consent for agreement of the implantation procedure.
Who may be able to join
- Age over 18 years old;
- Atrioventricular block patients with indication for permanent ventricular pacing;
- LVEF> 40%;
- With informed consent signed
Who cannot join
- Persistent atrial fibrillation;
- Moderate or more severe valvular disease;
- Hypertrophic cardiomyopathy；
- Myocardial amyloidosis；
- With indication for CRT or ICD implantation according to the current guideline;
- Poor condition of the acoustic window because of emphysema or other reasons;
- Patients refused postoperative follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fu Wai Hospital
Beijing, Beijing Municipality, 100037
Xiaofei Li, Master, 17801013995, lixiaofei0103@163.com
Xiaohan Fan, MD,PhD, 13811421067, fanxiaohan@fuwaihospital.org
About this study
Official title: Permanent Left Bundle Branch Area Pacing for Atrioventricular Block
Right ventricular pacing (RVP) causes left ventricular mechanical dyssynchrony by inducing electrical interventricular and intraventricular dyssynchrony. His bundle pacing may restore the the atrioventricular, interventricular and intraventricular electrical synchronization, however, Increased pacing threshold might result in the early depletion of the pacemaker, and finally brought on pacemaker replacement, which was one of the major causes of device infection. Pacing the left bundle branch beyond the conduction block site might achieve a low and stable output and narrow QRSd. The investigators were prepared to consecutively include patients with atrioventricular block, divided into the left bundle branch area pacing(LBBAP) group and the conventional right ventricular pacing group. The electrophysiological characteristics of LBBAP and right ventricular pacing were compared with ECG characteristics. The left and right ventricular synchrony and left and right cardiac function were evaluated by 3D ultrasound, and the short-term and long-term safety and efficacy of LBBAP were evaluated.
Read the detailed description
This study is intended to be included in Fuwai hospital for admission to the atrioventricular block, with permanent pacemaker implant indications recommended by current guidelines. Patients were assessed for preoperative electrocardiogram, quality of life scores, cardiac function, and left and right ventricular synchrony. Patients were followed up by regular outpatients. The electrocardiogram, quality of life score, echocardiographic function, left and right ventricular synchrony, pacing parameters and pacing ratio were evaluated immediately after surgery, 3 months, 6 months, and 12 months after surgery. At the same time, the left bundle branch area pacing success rate, complications during intraoperative and postoperative follow-up were recorded.
- Being tested
- permanent left bundle branch area pacing
- Keywords
- Atrioventricular Block, left bundle branch area pacing
- Medical subject headings
- Atrioventricular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
permanent left bundle branch area pacingDevice
Implant the pacing lead in the left bundle branch area instead of traditional RV pacing site(septal or apical). Successful LBBAP was defined as the paced QRS morphology of right bundle branch block pattern in lead V1 and QRS duration (QRSd) less than 130ms.
| Study group | Role | What they receive |
|---|---|---|
| LBBAP group | patients received left bundle branch area pacing Receives: Device: permanent left bundle branch area pacing | |
| traditional RVP group | Age and sex-matched patients received traditional right ventricular pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The synchronization status change at 3 months and 1 year as compared with baseline status.
Left ventricualr strain change from baseline to 3 month, from baselin to 1 year post operation.
Measured: 3 months and 1 year
Secondary outcomes (6)
Pacing threshold change at 3 months and 1 year as compared with baseline status.
The pacing threshold changes between 3-month and baseline status, changes between 1 year and the baseline status.
Measured: 3 months and 1 year
LBBAP related adverse events at 3 months and 1 year as compared with baseline status.
The adverse events includes perforation, acute myocardial infarction, loss of capture, increase of pacing threshold, et al. These events were evaluated at baseline, 3 months and 1 year after the procedure, respectively.
Measured: 3 months and 1 year
left ventricular ejection fraction change at 3 months and 1 year
Left ventricular ejection fraction change from baseline to 3 month, from baselin to 1 year post operation.
Measured: 3 months and 1 year
Right ventricular ejection fraction change at 3 months and 1 year
Right ventricular ejection fraction change from baseline to 3 month, from baselin to 1 year post operation.
Measured: 3 months and 1 year
Left ventricular end systolic diameter change at 3 months and 1 year
Left ventricular end systolic diameter change from baseline to 3 month, from baselin to 1 year post operation.
Measured: 3 months and 1 year
Left ventricular end diastolic diameter change at 3 months and 1 year
Left ventricular end diastolic diameter change from baseline to 3 month, from baselin to 1 year post operation.
Measured: 3 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start1 May 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Atrioventricular BlockStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Wai Hospital, Beijing, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fan Xiaohan, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851315
- Sponsor's protocol ID
- LBBAP-001
- Status last verified
- Feb 2019
- First submitted
- 18 Feb 2019
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Vijayaraman P, Naperkowski A, Ellenbogen KA, Dandamudi G. Electrophysiologic Insights Into Site of Atrioventricular Block: Lessons From Permanent His Bundle Pacing. JACC Clin Electrophysiol. 2015 Dec;1(6):571-581. doi: 10.1016/j.jacep.2015.09.012. Epub 2015 Oct 17.
PubMed 29759411Huang W, Su L, Wu S, Xu L, Xiao F, Zhou X, Ellenbogen KA. A Novel Pacing Strategy With Low and Stable Output: Pacing the Left Bundle Branch Immediately Beyond the Conduction Block. Can J Cardiol. 2017 Dec;33(12):1736.e1-1736.e3. doi: 10.1016/j.cjca.2017.09.013. Epub 2017 Sep 22.
PubMed 29173611Chen K, Li Y, Dai Y, Sun Q, Luo B, Li C, Zhang S. Comparison of electrocardiogram characteristics and pacing parameters between left bundle branch pacing and right ventricular pacing in patients receiving pacemaker therapy. Europace. 2019 Apr 1;21(4):673-680. doi: 10.1093/europace/euy252.
PubMed 30462207Guo XG, Liu X, Zhou GB, Sun Q, Yang JD, Luo B, Ouyang F, Ma J, Zhang S. Clinical, electrocardiographic, and electrophysiological characteristics of left upper septal fascicular ventricular tachycardia. Europace. 2018 Apr 1;20(4):673-681. doi: 10.1093/europace/euw429.
PubMed 28160481Upadhyay GA, Cherian T, Shatz DY, Beaser AD, Aziz Z, Ozcan C, Broman MT, Nayak HM, Tung R. Intracardiac Delineation of Septal Conduction in Left Bundle-Branch Block Patterns. Circulation. 2019 Apr 16;139(16):1876-1888. doi: 10.1161/CIRCULATIONAHA.118.038648.
PubMed 30704273Li X, Zhang J, Qiu C, Wang Z, Li H, Pang K, Yao Y, Liu Z, Xie R, Chen Y, Wu Y, Fan X. Clinical Outcomes in Patients With Left Bundle Branch Area Pacing vs. Right Ventricular Pacing for Atrioventricular Block. Front Cardiovasc Med. 2021 Jul 8;8:685253. doi: 10.3389/fcvm.2021.685253. eCollection 2021.
PubMed 34307499
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Permanent Left Bundle Branch Area Pacing for Atrioventricular Block
- ClinicalTrials.gov ID
- NCT03851315
- Acronym / sponsor ID
- LBBAP-001
- Keywords
- Atrioventricular Block, left bundle branch area pacing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Fu Wai Hospital, Beijing, ChinaUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 22 Feb 2019 (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.
Right ventricular pacing (RVP) causes left ventricular mechanical dyssynchrony by inducing electrical interventricular and intraventricular dyssynchrony. His bundle pacing may restore the the atrioventricular, interventricular and intraventricular electrical synchronization, however, Increased pacing threshold might result in the early depletion of the pacemaker, and finally brought on pacemaker replacement, which was one of the major causes of device infection. Pacing the left bundle branch beyond the conduction block site might achieve a low and stable output and narrow QRSd. The investigators were prepared to consecutively include patients with atrioventricular block, divided into the left bundle branch area pacing(LBBAP) group and the conventional right ventricular pacing group. The electrophysiological characteristics of LBBAP and right ventricular pacing were compared with ECG characteristics. The left and right ventricular synchrony and left and right cardiac function were evaluated by 3D ultrasound, and the short-term and long-term safety and efficacy of LBBAP were evaluated.
Detailed description
This study is intended to be included in Fuwai hospital for admission to the atrioventricular block, with permanent pacemaker implant indications recommended by current guidelines. Patients were assessed for preoperative electrocardiogram, quality of life scores, cardiac function, and left and right ventricular synchrony. Patients were followed up by regular outpatients. The electrocardiogram, quality of life score, echocardiographic function, left and right ventricular synchrony, pacing parameters and pacing ratio were evaluated immediately after surgery, 3 months, 6 months, and 12 months after surgery. At the same time, the left bundle branch area pacing success rate, complications during intraoperative and postoperative follow-up were recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LBBAP group | – | Device: permanent left bundle branch area pacingpatients received left bundle branch area pacing |
| traditional RVP group | – | –Age and sex-matched patients received traditional right ventricular pacing |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive AVB patients with indications for ventricular pacing according to 2013 ESC/EHRA Guidelines. Patients with persistent atrial fibrillation or indications for cardiac resynchronization therapy or implantable cardioverter defibrillator implantation , hypertrophic cardiomyopathy, myocardial amyloidosis, or refused postoperative follow-up were excluded. All patients should sign written informed consent for agreement of the implantation procedure.
Key inclusion criteria (4 listed)
- Age over 18 years old;
- Atrioventricular block patients with indication for permanent ventricular pacing;
- LVEF> 40%;
- With informed consent signed
Key exclusion criteria (7 listed)
- Persistent atrial fibrillation;
- Moderate or more severe valvular disease;
- Hypertrophic cardiomyopathy；
- Myocardial amyloidosis；
- With indication for CRT or ICD implantation according to the current guideline;
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 |
|---|---|---|
| permanent left bundle branch area pacingImplant the pacing lead in the left bundle branch area instead of traditional RV pacing site(septal or apical). Successful LBBAP was defined as the paced QRS morphology of right bundle branch block pattern in lead V1 and QRS duration (QRSd) less than 130ms. | Device | LBBAP group |
Primary outcome
The synchronization status change at 3 months and 1 year as compared with baseline status.
Time frame: 3 months and 1 year
Left ventricualr strain change from baseline to 3 month, from baselin to 1 year post operation.
6 secondary outcomes
Pacing threshold change at 3 months and 1 year as compared with baseline status.
Time frame: 3 months and 1 year
LBBAP related adverse events at 3 months and 1 year as compared with baseline status.
Time frame: 3 months and 1 year
left ventricular ejection fraction change at 3 months and 1 year
Time frame: 3 months and 1 year
Right ventricular ejection fraction change at 3 months and 1 year
Time frame: 3 months and 1 year
Left ventricular end systolic diameter change at 3 months and 1 year
Time frame: 3 months and 1 year
Left ventricular end diastolic diameter change at 3 months and 1 year
Time frame: 3 months and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
- Background: PubMed 29759411Vijayaraman P, Naperkowski A, Ellenbogen KA, Dandamudi G. Electrophysiologic Insights Into Site of Atrioventricular Block: Lessons From Permanent His Bundle Pacing. JACC Clin Electrophysiol. 2015 Dec;1(6):571-581. doi: 10.1016/j.jacep.2015.09.012. Epub 2015 Oct 17.
- Results publication: PubMed 29173611Huang W, Su L, Wu S, Xu L, Xiao F, Zhou X, Ellenbogen KA. A Novel Pacing Strategy With Low and Stable Output: Pacing the Left Bundle Branch Immediately Beyond the Conduction Block. Can J Cardiol. 2017 Dec;33(12):1736.e1-1736.e3. doi: 10.1016/j.cjca.2017.09.013. Epub 2017 Sep 22.
- Results publication: PubMed 30462207Chen K, Li Y, Dai Y, Sun Q, Luo B, Li C, Zhang S. Comparison of electrocardiogram characteristics and pacing parameters between left bundle branch pacing and right ventricular pacing in patients receiving pacemaker therapy. Europace. 2019 Apr 1;21(4):673-680. doi: 10.1093/europace/euy252.
- Results publication: PubMed 28160481Guo XG, Liu X, Zhou GB, Sun Q, Yang JD, Luo B, Ouyang F, Ma J, Zhang S. Clinical, electrocardiographic, and electrophysiological characteristics of left upper septal fascicular ventricular tachycardia. Europace. 2018 Apr 1;20(4):673-681. doi: 10.1093/europace/euw429.
- Results publication: PubMed 30704273Upadhyay GA, Cherian T, Shatz DY, Beaser AD, Aziz Z, Ozcan C, Broman MT, Nayak HM, Tung R. Intracardiac Delineation of Septal Conduction in Left Bundle-Branch Block Patterns. Circulation. 2019 Apr 16;139(16):1876-1888. doi: 10.1161/CIRCULATIONAHA.118.038648.
- Derived from this study: PubMed 34307499Li X, Zhang J, Qiu C, Wang Z, Li H, Pang K, Yao Y, Liu Z, Xie R, Chen Y, Wu Y, Fan X. Clinical Outcomes in Patients With Left Bundle Branch Area Pacing vs. Right Ventricular Pacing for Atrioventricular Block. Front Cardiovasc Med. 2021 Jul 8;8:685253. doi: 10.3389/fcvm.2021.685253. eCollection 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrioventricular Block and Left Bundle Branch Area Pacing, run by Fu Wai Hospital, Beijing, China 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 7 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 22 Feb 2019. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The synchronization status change at 3 months and 1 year as compared with baseline status. (time frame: 3 months and 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 NCT03851315, which also lists 6 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 22 Feb 2019.