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

Sponsor

Medtronic Cardiac Rhythm and Heart Failure (Industry)

Overall Status

Completed

CT.gov ID

NCT04023890

Collaborator

(none)

Enrollment

Location

12.6

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Pacing Pacing Therapy Pacemaker

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.

Study Design

Study Type:

Observational

Actual Enrollment :

22 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 14, 2019

Actual Primary Completion Date :

Jul 1, 2019

Actual Study Completion Date :

Jan 31, 2020

Outcome Measures

Primary Outcome Measures

QRS duration [During implant]
The primary endpoint is QRS duration during bundle branches area pacing

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fuwai Hospital	Beijing	Beijing	China	100037

Sponsors and Collaborators

Medtronic Cardiac Rhythm and Heart Failure

Investigators

Study Director: Xiaohong Zhou, M.D., Medtronic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medtronic Cardiac Rhythm and Heart Failure

ClinicalTrials.gov Identifier:

NCT04023890

Other Study ID Numbers:

Bundle Branches Area Pacing

First Posted:

Jul 18, 2019

Last Update Posted:

Feb 6, 2020

Last Verified:

Feb 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 6, 2020