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出境医 / 临床实验 / Ventricular Electrical Synchronization by Stimulating Left and Right Bundle Branches Area in Pacing-indicated Patients

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

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
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
Layout table for study information
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 : January 14, 2019
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : January 31, 2020
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. QRS duration [ Time Frame: During implant ]
    The primary endpoint is QRS duration during bundle branches area pacing


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will enroll subjects who have pacing indications or indications for CRT.
Criteria

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
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China, Beijing
Fuwai Hospital
Beijing, Beijing, China, 100037
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
Layout table for investigator information
Study Director: Xiaohong Zhou, M.D. Medtronic
Tracking Information
First Submitted Date July 16, 2019
First Posted Date July 18, 2019
Last Update Posted Date February 6, 2020
Actual Study Start Date January 14, 2019
Actual Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 17, 2019)
QRS duration [ Time Frame: During implant ]
The primary endpoint is QRS duration during bundle branches area pacing
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ventricular Electrical Synchronization by Stimulating Left and Right Bundle Branches Area in Pacing-indicated Patients
Official Title Ventricular Electrical Synchronization by Stimulating Left and Right Bundle Branches Area in Pacing-indicated Patients
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population This study will enroll subjects who have pacing indications or indications for CRT.
Condition
  • Cardiac Pacing
  • Pacing Therapy
  • Pacemaker
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 5, 2020)
22
Original Estimated Enrollment
 (submitted: July 17, 2019)
20
Actual Study Completion Date January 31, 2020
Actual Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04023890
Other Study ID Numbers Bundle Branches Area Pacing
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Medtronic Cardiac Rhythm and Heart Failure
Study Sponsor Medtronic Cardiac Rhythm and Heart Failure
Collaborators Not Provided
Investigators
Study Director: Xiaohong Zhou, M.D. Medtronic
PRS Account Medtronic Cardiac Rhythm and Heart Failure
Verification Date February 2020