Atrioventricular Block Clinical Trial
Official title:
Permanent Left Bundle Branch Area Pacing for Atrioventricular Block
NCT number | NCT03851315 |
Other study ID # | LBBAP-001 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2018 |
Est. completion date | June 30, 2021 |
Verified date | February 2019 |
Source | Fu Wai Hospital, Beijing, China |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 45 |
Est. completion date | June 30, 2021 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: 1. Age over 18 years old; 2. Atrioventricular block patients with indication for permanent ventricular pacing; 3. LVEF> 40%; 4. With informed consent signed Exclusion Criteria: 1. Persistent atrial fibrillation; 2. Moderate or more severe valvular disease; 3. Hypertrophic cardiomyopathy; 4. Myocardial amyloidosis; 5. With indication for CRT or ICD implantation according to the current guideline; 6. Poor condition of the acoustic window because of emphysema or other reasons; 7. Patients refused postoperative follow-up. |
Country | Name | City | State |
---|---|---|---|
China | Fu Wai Hospital | BeiJing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Fu Wai Hospital, Beijing, China |
China,
Chen 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. 2018 Nov 20. doi: 10. — View Citation
Guo 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/euro — View Citation
Huang 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.2017.0 — View Citation
Upadhyay GA, Cherian T, Shatz DY, Beaser AD, Aziz Z, Ozcan C, Broman MT, Nayak H, Tung R. Intracardiac Delineation of Septal Conduction in Left Bundle Branch Block Patterns: Mechanistic Evidence of Left Intra-Hisian Block Circumvented by His Pacing. Circu — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 3 months and 1 year | |
Secondary | 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. | 3 months and 1 year | |
Secondary | 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. | 3 months and 1 year | |
Secondary | 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. | 3 months and 1 year | |
Secondary | 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. | 3 months and 1 year | |
Secondary | 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. | 3 months and 1 year | |
Secondary | 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. | 3 months and 1 year |
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