Heart FailureCardioInsight1NCT05555966
CardioInsight 1 RBBB
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.
Trial summary
Cardiac resynchronization therapy (CRT) is an established therapy for symptomatic heart failure patients. However, there are still 30 to 40% of studied patients being nonresponder to CRT. The plausible reasons of lack of effect of CRT in these patients include relative less baseline electrical dyssynchrony. 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
- 93 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2017to 31 Dec 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
- Ischemic or non-ischemic cause of heart failure
- QRS duration > 120 ms, non-left bundle branch block (LBBB) type of conduction disturbance
- NYHA class III or above
- Informed consent by the patient
- Already received stable dose of guideline directed medical therapy for at least 3 months
Who cannot join
- LBBB patients
- Pregnant women
- Participation in another study
- Patient with contraindication to left ventricle catheterization by a retrograde aortic approach
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Shatin, 999077
Daniel Xu, 35051518 ext. 1518, danielxu@cuhk.edu.hk
About this study
Official title: Electrical Activation Mapping Guided Tailor Made Approach for Cardiac Resynchronization Therapy
Cardiac resynchronization therapy (CRT) is an established therapy for symptomatic heart failure patients. However, there are still 30 to 40% of studied patients being nonresponder to CRT. The plausible reasons of lack of effect of CRT in these patients include relative less baseline electrical dyssynchrony. The aim of our study is to investigate whether there is an optimal configuration of CRT delivery that varies between patients with different pattern of activation delay.
- 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 group | Role | What they receive |
|---|---|---|
| Tailor-made CRT delivery | Experimental | Device placement based on 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.
Left Ventricle (LV) end systolic volume reduction
The responder rate of greater than 10% of LV end systolic volume reduction measured by echocardiogram
Measured: 6 months
Secondary outcomes (17)
Electrical dyssynchrony index
The acute electrical dyssynchrony indices (the standard deviation of activation times throughout the epicardium) of different methods of CRT delivery. Lower indicate larger improvement.
Measured: During procedure
Hemodynamic response monitoring
monitor the difference in hemodynamic responses of different methods of CRT delivery method. The hemodynamic response will be maximal dp/dt as measured by pressure wire introduced into the left ventricle during the procedure.
Measured: During procedure
Procedure outcome with optimal CRT delivery
Procedure outcome measured by procedure duration and implantation success rate of the optimal CRT delivery method as determined by the best improvement in electrical dyssynchrony indices.
Measured: During procedure
Cine images and chest X ray
Cine images (PA, LAO 300, RAO 300) and Chest X ray (PA view) of patients will be obtained for evaluation of changes in disease
Measured: 6 months
Echocardiogram parameter: left ventricular systolic and diastolic volume
left ventricular systolic and diastolic volume at baseline, 3 months and 6 months : , left ventricular ejection fraction, degree of mitral regurgitation, strain imaging will be aggregated to arrive at an overall change in echocardiogram parameters as together they represent integrated heart function collectively, as reflected by the listed echocardiogram parameters.
Measured: 6 months
Multi-dimensional Quality of life changes
change in New York Heart Association (NYHA) class, 6 minute hall walk test, HF Patient Global Assessment Questionnaire and quality of life using Minnesota's living with heart failure (MLWHF) questionnaire at baseline, 3 months and 6 months.
Measured: 6 months
Device set-up parameter :defibrillation threshold
Device parameters including defibrillation threshold at implant and 6 months follow-up.
Measured: 6 months
Post-operation Complication rate
Peri-operative and 6 months follow-up complications rate:
- Thromboembolic event
- Dislodgement and migration of pacing leads
- Phrenic nerve stimulation
- Others
Measured: 6 months
Device set-up parameter :defibrillation sensitivity
Device set-up parameter :defibrillation sensitivity at implant and 6 months follow-up
Measured: 6 months
Device set-up parameter: lead impedance of pacing leads
Device set-up parameter: lead impedance of pacing leads at implant and 6 months follow-up
Measured: 6 months
Change in 6 minute hall walk test
Change in 6 minute hall walk test result, at baseline, 3 months and 6 months.
Measured: 6 months
Change in HF Patient Global Assessment Questionnaire
HF Patient Global Assessment Questionnaire at baseline, 3 months and 6 months.
Measured: 6 months
Change in quality of life
Change in quality of life assessed by Minnesota's living with heart failure (MLWHF) questionnaire at baseline, 3 months and 6 months.
Measured: 6 months
Implantation success rate with optimal CRT delivery
Implantation success rate of the optimal CRT delivery method as determined by the best improvement in electrical dyssynchrony indices.
Measured: During procedure
Echocardiogram parameter: left ventricular ejection fraction
Echocardiogram parameter: left ventricular ejection fraction at baseline, 3 months and 6 months
Measured: 6 months
Echocardiogram parameter: degree of mitral regurgitation
Echocardiogram parameter: degree of mitral regurgitation at baseline, 3 months and 6 months
Measured: 6 months
Echocardiogram parameter: strain imaging
Echocardiogram parameter: strain imaging at baseline, 3 months and 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start1 Sep 2017
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Bryan Ping Yen YAN, Chinese University of Hong Kong
- Investigators
- Bryan Yan, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555966
- Sponsor's protocol ID
- 2017.316
- Acronym
- CardioInsight1
- Status last verified
- Sep 2022
- First submitted
- 15 Sep 2022
- Last updated
- 27 Sep 2022
- 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 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Activation Mapping Guided Tailor Made Approach for Cardiac Resynchronization Therapy
- ClinicalTrials.gov ID
- NCT05555966
- Acronym / sponsor ID
- CardioInsight1 / 2017.316
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Sep 2022 (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.
Cardiac resynchronization therapy (CRT) is an established therapy for symptomatic heart failure patients. However, there are still 30 to 40% of studied patients being nonresponder to CRT. The plausible reasons of lack of effect of CRT in these patients include relative less baseline electrical dyssynchrony. The aim of our study is to investigate whether there is an optimal configuration of CRT delivery that varies between patients with different pattern of activation delay.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tailor-made CRT delivery | Experimental | Device: Electrical Activation Mapping Guided Cardiac resynchronization therapyDevice placement based on Electrical Activation Mapping result |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult (aged 18 or above) of both sexes
- Ischemic or non-ischemic cause of heart failure
- QRS duration > 120 ms, non-left bundle branch block (LBBB) type of conduction disturbance
- NYHA class III or above
- Informed consent by the patient
Key exclusion criteria (4 listed)
- LBBB patients
- Pregnant women
- Participation in another study
- Patient with contraindication to left ventricle catheterization by a retrograde aortic approach
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical Activation Mapping Guided Cardiac resynchronization therapyTo study the feasibility to optimize configuration of CRT delivery for acute correction of electrical dyssynchrony using a noninvasive mapping of global electrical activation | Device | Tailor-made CRT delivery |
Primary outcome
Left Ventricle (LV) end systolic volume reduction
Time frame: 6 months
The responder rate of greater than 10% of LV end systolic volume reduction measured by echocardiogram
17 secondary outcomes
Electrical dyssynchrony index
Time frame: During procedure
Hemodynamic response monitoring
Time frame: During procedure
Procedure outcome with optimal CRT delivery
Time frame: During procedure
Cine images and chest X ray
Time frame: 6 months
Echocardiogram parameter: left ventricular systolic and diastolic volume
Time frame: 6 months
Multi-dimensional Quality of life changes
Time frame: 6 months
Device set-up parameter :defibrillation threshold
Time frame: 6 months
Post-operation Complication rate
Time frame: 6 months
Device set-up parameter :defibrillation sensitivity
Time frame: 6 months
Device set-up parameter: lead impedance of pacing leads
Time frame: 6 months
Change in 6 minute hall walk test
Time frame: 6 months
Change in HF Patient Global Assessment Questionnaire
Time frame: 6 months
Change in quality of life
Time frame: 6 months
Implantation success rate with optimal CRT delivery
Time frame: During procedure
Echocardiogram parameter: left ventricular ejection fraction
Time frame: 6 months
Echocardiogram parameter: degree of mitral regurgitation
Time frame: 6 months
Echocardiogram parameter: strain imaging
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
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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.
Bryan Yan principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
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 6 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: status not confirmed, as of the sponsor's last update on 27 Sep 2022. 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?
Left Ventricle (LV) end systolic volume reduction (time frame: 6 months). 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 27 Sep 2022.