Ventricular Electrical Synchronization by Stimulating Left and Right Bundle Branches Area in Pacing-indicated Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04023890

Enrollment

Registered

2019-07-18

Start date

2019-01-14

Completion date

2020-01-31

Last updated

2020-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Pacing, Pacemaker, Pacing Therapy

Brief summary

This is a prospective, single-site, non-randomized, acute feasibility clinical study. The purpose of this study is to explore the electrocardiogram (ECG) characteristics of simultaneous stimulation of right and left bundle branches area.

Detailed description

Many pacemaker patients have cardiac conduction system disease and thus need ventricular pacing. Traditional ventricular pacing causes ventricular dyssynchrony that in turn causes cardiac contraction dysfunction. CRT pacing provides better ventricular synchronization, but not the optimal, especially in patients with narrow QRS. CRT non-response rate is at 30%. His bundle pacing utilizes naturel His bundle-Purkinjie system to provide optimal physiological pacing. But many pacing-indicated patients have abnormal His bundle-Purkinje system, thus His bundle pacing cannot provide optimal pacing in patients with abnormal cardiac conduction system. Moreover, the pacing threshold is high during His bundle pacing. More recently, left bundle branch pacing is proposed. However, LBBP will generate right bundle branch block pattern, another kind of weak ventricular synchronization. Thus, the investigators propose to excite the left and right bundle branches area simultaneously to normalize ventricular synchronization. The purpose of this study is to explore the electrocardiogram (ECG) characteristics of simultaneous stimulation of right and left bundle branches area.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Aged from 18 to 80 years old * Subjects who are willing to provide Informed Consent * Subjects who have pacing indications or indications for CRT, and will receive pacemaker or CRT therapy

Exclusion criteria

* Subjects who have contra-indications for pacing therapy or CRT * CRT up-graded subjects * Ventricular hypertrophy * Subjects who have medical conditions that would limit study participation * Subjects who are pregnant or have a plan for pregnancy during the study * Subjects who are not willing to provide Informed Consent

Design outcomes

Primary

Measure	Time frame	Description
QRS duration	During implant	The primary endpoint is QRS duration during bundle branches area pacing

Countries

China

Outcome results