CardioInsight 1 RBBB

NCT ID: NCT05555966

Last Updated: 2022-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tailor-made CRT delivery

Device placement based on Electrical Activation Mapping result

Group Type EXPERIMENTAL

Electrical Activation Mapping Guided Cardiac resynchronization therapy

Intervention Type DEVICE

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

Interventions

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Electrical Activation Mapping Guided Cardiac resynchronization therapy

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* LBBB patients
* Pregnant women
* Participation in another study
* Patient with contraindication to left ventricle catheterization by a retrograde aortic approach
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Professor Bryan Ping Yen YAN

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bryan Yan

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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The Chinese University of Hong Kong

Shatin, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Daniel Xu

Role: CONTACT

Facility Contacts

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Daniel Xu

Role: primary

35051518 ext. 1518

Other Identifiers

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2017.316

Identifier Type: -

Identifier Source: org_study_id

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