Cardiac PacingNCT04023890
Ventricular Electrical Synchronization by Stimulating Left and Right Bundle Branches Area in Pacing-indicated Patients
An observational study of Cardiac Pacing and Pacing Therapy, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Pacing, Pacing Therapy, Pacemaker
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 14 Jan 2019to 31 Jan 2020
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will enroll subjects who have pacing indications or indications for CRT.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cardiac Pacing, Pacing Therapy, Pacemaker
What is being measured
The primary outcome is the main question the study is designed to answer.
QRS duration
The primary endpoint is QRS duration during bundle branches area pacing
Measured: During implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start14 Jan 2019
- Primary completion1 Jul 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac PacingStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaohong Zhou, M.D., Study director, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023890
- Sponsor's protocol ID
- Bundle Branches Area Pacing
- Status last verified
- Feb 2020
- First submitted
- 16 Jul 2019
- Last updated
- 6 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventricular Electrical Synchronization by Stimulating Left and Right Bundle Branches Area in Pacing-indicated Patients
- ClinicalTrials.gov ID
- NCT04023890
- Acronym / sponsor ID
- Bundle Branches Area Pacing
- Conditions
- Cardiac Pacing, Pacing Therapy, Pacemaker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 18 Jul 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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll subjects who have pacing indications or indications for CRT.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
QRS duration
Time frame: During implant
The primary endpoint is QRS duration during bundle branches area pacing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
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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.
Xiaohong Zhou, M.D. study director
Medtronic
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 Cardiac Pacing and Pacing Therapy, run by Medtronic Cardiac Rhythm and Heart Failure 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 6 Feb 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QRS duration (time frame: During implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2020.