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Heart FailureCardioInsight3NCT05556018

CardioInsight 3 - LBBB

A study testing Electrical Activation Mapping Guided Cardiac resynchronization therapy in people with Heart Failure, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Background Cardiac Resynchronization Therapy (CRT) is proven to improve survival and heart function of patient with certain electrical conduction abnormality and heart failure. However, in patient with certain electrical conduction abnormality, being nonresponder is observed in up to 40% in patient receiving CRT. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
Electrical Activation Mapping Guided Cardiac resynchronization therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteHong Kong
Study dates
5 Jul 2019to 31 Mar 2024
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult (aged 18 or above) of both sexes
  • Candidate for CRT therapy according to international guidelines.7
  • Informed consent by the patient
  • Already received stable dose of guideline directed medical therapy for at least 3 months

Who cannot join

  • Pregnant
  • Participating in another study

Trial locations and contacts

1 site in 1 country.

Daniel Xu contact

35051518

danielxu@cuhk.edu.hk

Hong Kong1 site, 1 recruiting

  • The Chinese University of Hong Kong

    Shatin, 999077

    Daniel Xu, 35051518 ext. 1518, danielxu@cuhk.edu.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: Activation Pattern and Acute Hemodynamics of His and Left Bundle Pacing

Background Cardiac Resynchronization Therapy (CRT) is proven to improve survival and heart function of patient with certain electrical conduction abnormality and heart failure. However, in patient with certain electrical conduction abnormality, being nonresponder is observed in up to 40% in patient receiving CRT. Conventionally the surgical approach of CRT is to implant one pacing lead in the right heart and one in the left heart to resynchronize the contraction and the pacing lead in the left heart is usually placed in the posterior or lateral portion of the left heart. However, this single approach may not be optimal, especially for those patients with conduction abnormality known to have no response to CRT. Purpose of the clinical investigation The purpose of the Activation Pattern and Acute Hemodynamics of His and Left Bundle Pacing is to study the acute effect on the heart function and conduction abnormality of His and left bundle pacing in conventional CRT candidate. During CRT implantation, Hisbundle lead and Left bundle pacing lead will be placed and the acute effect on heart function will be studied by a wire placed in the left ventricle of the heart and the activation pattern will be studied by a noninvasive global mapping system. The pacing approach that optimally corrects conduction abnormality and improvement on the heart function acutely will be determined

Conditions
Heart Failure
Being tested
Electrical Activation Mapping Guided Cardiac resynchronization therapy
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electrical Activation Mapping Guided Cardiac resynchronization therapyDevice

    To study the feasibility to optimize configuration of CRT delivery for acute correction of electrical dyssynchrony using a noninvasive mapping of global electrical activation

Study groups in NCT05556018
Study groupRoleWhat they receive
Tailor-made CRT deliveryExperimentalCardiac resynchronization therapy given according to Electrical Activation Mapping result
Receives: Device: Electrical Activation Mapping Guided Cardiac resynchronization therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement in myocardiac activation

    Correction of activation abnormality as evaluated by global noninvasive mapping system (ECGi) seen as an increase in acute dp/dt > 5% from baseline with left bundle pacing comparing to biventricular pacing.

    Measured: 6 months

Secondary outcomes (14)

  1. Procedure duration

    Procedure duration of the optimal CRT delivery method as determined by the best improvement in electrical desynchrony indices.

    Measured: during procedure

  2. Implantation success rate

    Implantation success rate of the optimal CRT delivery method as determined by the best improvement in electrical desynchrony indices.

    Measured: during procedure

  3. Cine images and chest X ray

    Cine images (PA, LAO 300, RAO 300) and Chest X ray (PA view) obtained during course of study for assessment of disease

    Measured: 6 months

  4. Echocardiogram parameters: strain imaging

    Echocardiogram parameters: strain imaging at baseline, 3 months and 6 months

    Measured: 6 months

  5. Echocardiogram parameters: left ventricular systolic and diastolic volume

    Echocardiogram parameters: left ventricular systolic and diastolic volume at baseline, 3 months and 6 months

    Measured: 6 months

  6. Echocardiogram parameters: left ventricular ejection fraction

    Echocardiogram parameters: left ventricular ejection fraction at baseline, 3 months and 6 months

    Measured: 6 months

  7. Echocardiogram parameters: degree of mitral regurgitation

    Echocardiogram parameters at baseline, 3 months and 6 months

    Measured: 6 months

  8. Change in New York Heart Association class

    Comparison of NYHA class at baseline, 3 months and 6 months to assess changes in quality of life of subject.

    Measured: 6 months

  9. Device parameter: defibrillation threshold

    Electrical parameters including defibrillation threshold at implant and 6 months follow-up.

    Measured: 6 months

  10. post-operative complication rate

    Peri-operative and 6 months follow-up complications rate:

    1. Thromboembolic event
    2. Dislodgement and migration of pacing leads
    3. Phrenic nerve stimulation
    4. Others

    Measured: 6 months

  11. Device parameter: defibrillation sensitivity

    Electrical parameters including defibrillation sensitivity at implant and 6 months follow-up.

    Measured: 6 months

  12. Device parameter: lead impedance

    Electrical parameters including lead impedance of pacing leads at addition of new lead and 6 months follow-up.

    Measured: 6 months

  13. Change in 6 minute hall walk test result

    Comparison of 6 minute hall walk test result at baseline, 3 months and 6 months to assess changes in quality of life of subject.

    Measured: 6 months

  14. Change in HF Patient Global Assessment Questionnaire outcome

    Comparison of HF Patient Global Assessment Questionnaire outcome at baseline, 3 months and 6 months to assess changes in quality of life of subject.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2022
  2. Study start5 Jul 2019
  3. Primary completion31 Dec 2023
  4. Study completion31 Mar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05556018
Sponsor's protocol ID
2019.021-T
Acronym
CardioInsight3
Status last verified
Feb 2024
First submitted
16 Sep 2022
Last updated
16 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Electrical Activation Mapping Guided Cardiac resynchronization therapy in people with Heart Failure, run by Chinese University of Hong Kong at 1 site in Hong Kong.

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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 Feb 2024. 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 Hong Kong. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Daniel Xu (35051518, danielxu@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in myocardiac activation (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05556018.

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 16 Feb 2024.

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