Cardiac PacingNCT04738396
Electrogram and Hemodynamic Characteristics of Adaptive LBBAP in Patients With Heart Failure or Bradycardia
An observational study of Cardiac Pacing and Pacing Therapy, run by Medtronic Cardiac Rhythm and Heart Failure at 4 sites in China.
Trial summary
This is a multi-site, non-randomized, data collection study. The purpose of this study is to investigate the cardiac electrical and mechanical function during LBBAP with different AV intervals. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Pacing, Pacing Therapy
- How many people
- 52 participants
- Where
- 4 sitesChina
- Study dates
- 29 Dec 2020to 8 Dec 2022
- 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: Patients who received LBBAP for at least 3 months and come back to hospital for regular follow-up will be considered to be recruited voluntarily.
Who may be able to join
- Patients aged from 18 to 80 years old
- Patients who are willing to provide Informed Consent
- Patients who received LBBAP for at least 3 months
- Patients' implanted device can provide intracardiac electrograms
- Bradycardia patients with AVB or heart failure patients with LBBB
Who cannot join
- Patients who are pregnant or have a plan for pregnancy during the study
- Patients with persistent AF
- Patients who have medical conditions that would limit study participation
- Patients who were already enrolled in other clinical trial which would impact his/her participation
Trial locations and contacts
4 sites in 1 country.
China4 sites
Fuwai Hospital
Beijing, Beijing Municipality, 100037
Zhejiang Greentown Cardiovascular Hospital
Hangzhou, Zhejiang, 310011
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310020
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
About this study
This is a multi-site, non-randomized, data collection study. The purpose of this study is to investigate the cardiac electrical and mechanical function during LBBAP with different AV intervals.
Read the detailed description
Left bundle branch pacing (LBBP), achieved via trans-septal approach with the pacing tip at the left side of the ventricular septum, has recently initiated and been well practiced in China. LBBP is characterized with relatively ease of implantation (usually <5 minutes fluoroscopic use time), narrow paced QRS duration (similar to physiological pacing), low and stable pacing threshold (usually around 0.5V @0.5ms, good for device longevity and long-term stability without need of back-up pacing lead), high R wave amplitude for pacing management, and LBBB (left bundle branch block) correction by a low pacing output.
LBBAP (left bundle branch area pacing) can generate a relatively narrow QRSd and fast left ventricular activation. As AV interval is an important pacing parameter relevant to cardiac function. This study is to investigate the cardiac electrical and mechanical function during LBBAP with different AV intervals.
- Conditions
- Cardiac Pacing, Pacing Therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
ECG QRS duration
The primary endpoint is QRS duration during LBBP
Measured: At least 3 months post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start29 Dec 2020
- Primary completion6 Sep 2022
- Study completion8 Dec 2022
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.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- 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
- 52 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, Study director, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04738396
- Sponsor's protocol ID
- aLBBAP study
- Status last verified
- Feb 2023
- First submitted
- 1 Feb 2021
- Last updated
- 21 Feb 2023
- 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 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrogram and Hemodynamic Characteristics of Adaptive LBBAP in Patients With Heart Failure or Bradycardia
- ClinicalTrials.gov ID
- NCT04738396
- Acronym / sponsor ID
- aLBBAP study
- Conditions
- Cardiac Pacing, Pacing Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 29 Dec 2020 (actual)
- Primary completion
- 6 Sep 2022 (actual)
- Study completion
- 8 Dec 2022 (actual)
- First posted
- 4 Feb 2021 (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 multi-site, non-randomized, data collection study. The purpose of this study is to investigate the cardiac electrical and mechanical function during LBBAP with different AV intervals.
Detailed description
Left bundle branch pacing (LBBP), achieved via trans-septal approach with the pacing tip at the left side of the ventricular septum, has recently initiated and been well practiced in China. LBBP is characterized with relatively ease of implantation (usually <5 minutes fluoroscopic use time), narrow paced QRS duration (similar to physiological pacing), low and stable pacing threshold (usually around 0.5V @0.5ms, good for device longevity and long-term stability without need of back-up pacing lead), high R wave amplitude for pacing management, and LBBB (left bundle branch block) correction by a low pacing output.
LBBAP (left bundle branch area pacing) can generate a relatively narrow QRSd and fast left ventricular activation. As AV interval is an important pacing parameter relevant to cardiac function. This study is to investigate the cardiac electrical and mechanical function during LBBAP with different AV intervals.
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
- Patients who received LBBAP for at least 3 months and come back to hospital for regular follow-up will be considered to be recruited voluntarily.
Key inclusion criteria (5 listed)
- Patients aged from 18 to 80 years old
- Patients who are willing to provide Informed Consent
- Patients who received LBBAP for at least 3 months
- Patients' implanted device can provide intracardiac electrograms
- Bradycardia patients with AVB or heart failure patients with LBBB
Key exclusion criteria (4 listed)
- Patients who are pregnant or have a plan for pregnancy during the study
- Patients with persistent AF
- Patients who have medical conditions that would limit study participation
- Patients who were already enrolled in other clinical trial which would impact his/her participation
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
ECG QRS duration
Time frame: At least 3 months post implant
The primary endpoint is QRS duration during LBBP
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 21 Feb 2023.
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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 study director
Medtronic
4 sites 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 4 sites 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 5 inclusion and 4 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 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
ECG QRS duration (time frame: At least 3 months post 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 21 Feb 2023.