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Trial record 3 of 5 for:    18458170 [PUBMED-IDS]

Electrical Activation Mapping Guided Tailor Made Approach for Cardiac Resynchronization Therapy

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ClinicalTrials.gov Identifier: NCT03356652
Recruitment Status : Not yet recruiting
First Posted : November 29, 2017
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
Professor Bryan Ping Yen YAN, Chinese University of Hong Kong

Brief 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, a good response is observed in less than 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 poor response to CRT.

Purpose of the clinical investigation

The purpose of the Electrical Activation Guided CRT Study is to study the effectiveness of a tailored made approach to CRT procedure by using a noninvasive globally mapping system studying the electrical conduction under different approaches to delivery CRT. The pacing approach that optimally corrects conduction abnormality will be determined before the actual implantation procedure.

Conduct of the Investigation

This study will include 93 patients with conduction abnormality that known to have a poor response to CRT from Prince of Wales Hospital, Hong Kong.Subjects will be followed up at 3 months and 6 months visit.


Condition or disease Intervention/treatment Phase
Heart Failure Procedure: Noninvasive electrical dyssynchrony study Not Applicable

Detailed Description:

The purpose is to prospectively study the feasibility to optimize configuration of CRT delivery for acute correction of electrical dyssynchrony using a noninvasive mapping of global electrical activation.

Study Hypothesis: Tailor-made configuration of CRT delivery is feasible and able to improve responder rate compare to single method of CRT delivery in candidates with known poor response to CRT.

Primary outcome measure: Responder rate of greater than 10% of LV end systolic volume reduction in patients undergoing tailor-made approach of CRT delivery at 6 months. The responder rate is to compare with pre-defined level of 40% for single method of CRT delivery namely biventricular pacing with LV lead in coronary sinus.

Sample Size: The total required sample size is 93 patients with device implanted.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 93 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Electrical Activation Mapping Guided Tailor Made Approach for Cardiac Resynchronization Therapy
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : February 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Tailor-made CRT delivery
Patient undergoes acute noninvasive electrical dyssynchrony study with various CRT configurations. CRT device is then implanted with optimal configuration.
Procedure: Noninvasive electrical dyssynchrony study

Ventricular activation maps will be acquired simultaneously with hemodynamic measurements using noninvasive mapping system (ECVUE, Medtronic Inc, USA). A thoracic computed tomographic scan will be acquired with the electrodes attached to the patient. Local ventricular activation times will be defined as the onset of the QRS complex or the pacing spike to the maximal negative slope of each unipolar electrogram.

Pacing leads will be placed in high right atrium, His-bundle region, right ventricular apex, high septal RV, coronary sinus posterior/lateral branch, coronary sinus anterior branch, lateral and septal region of endocardial LV in order to deliver CRT in 8 different configurations.

Other Names:
  • Noninvasive electrical activation
  • Electrical Activation Mapping
  • Noninvasive mapping system
  • ECVUE



Primary Outcome Measures :
  1. Responder rate of greater than 10% of LV end systolic volume reduction in patients undergoing tailor-made approach of CRT delivery at 6 months. [ Time Frame: 6 months ]
    Responder rate of greater than 10% of LV end systolic volume reduction measured by echocardiogram comparing baseline and 6 months post implant in patients undergoing tailor-made approach of CRT delivery. Responder rate of greater than 10% of LV end systolic volume reduction measured by echocardiogram comparing baseline and 6 months post implant in patients undergoing tailor-made approach of CRT delivery. The responder rate is to compare with pre-defined level of 40% for single method of CRT delivery namely biventricular pacing with LV lead in coronary sinus.


Secondary Outcome Measures :
  1. The acute electrical dyssynchrony indices of different methods of CRT delivery. [ Time Frame: during procedure ]
    The acute electrical dyssynchrony indices of different methods of CRT delivery.

  2. The hemodynamic responses of different methods of CRT delivery. [ Time Frame: during procedure ]
    The hemodynamic responses of different methods of CRT delivery. The hemodynamic response will be maximal dp/dt as measured by pressure wire introduced into the left ventricle during the procedure.

  3. Procedure duration of the optimal CRT delivery method [ Time Frame: during procedure ]
    Procedure duration of the optimal CRT delivery method as determined by the best improvement in electrical dyssynchrony indices.

  4. Implantation success rate of the optimal CRT delivery method [ Time Frame: during procedure ]
    Implantation success rate of the optimal CRT delivery method as determined by the best improvement in electrical dyssynchrony indices.

  5. Cine images (PA, LAO 300, RAO 300) and Chest X ray (PA view) [ Time Frame: during procedure ]
    Cine images (PA, LAO 300, RAO 300) and Chest X ray (PA view)

  6. Peri-operative and 6 months follow-up complications rate: [ Time Frame: Peri-operative and 6 months ]
    1. Thromboembolic event
    2. Dislodgement and migration of pacing leads
    3. Phrenic nerve stimulation
    4. Others

  7. Left ventricular systolic and diastolic volume at baseline and 6 months: [ Time Frame: baseline and 6 months ]
    Echocardiogram parameter of left ventricular systolic and diastolic volume at baseline and 6 months.

  8. Left ventricular ejection fraction at baseline and 6 months: [ Time Frame: baseline and 6 months ]
    Echocardiogram parameter of left ventricular ejection fraction at baseline and 6 months.

  9. Degree of mitral regurgitation at baseline and 6 months: [ Time Frame: baseline and 6 months ]
    Echocardiogram parameter of degree of mitral regurgitation at baseline and 6 months.

  10. Strain imaging at baseline and 6 months: [ Time Frame: baseline and 6 months ]
    Echocardiogram parameter of strain imaging at baseline and 6 months.

  11. NYHA class [ Time Frame: baseline and 6 months ]
    NYHA class at baseline and 6 months.

  12. 6 minute hall walk test [ Time Frame: baseline and 6 months ]
    6 minute hall walk test at baseline and 6 months.

  13. Quality of life using Minnesota's questionnaire [ Time Frame: baseline and 6 months ]
    Quality of life using Minnesota's questionnaire at baseline and 6 months.

  14. Electrical parameters including threshold, sensitivity and lead impedance of pacing leads at implant and 6 months follow-up. [ Time Frame: during procedure and 6 months ]
    Electrical parameters including threshold, sensitivity and lead impedance of pacing leads at implant and 6 months follow-up.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult (aged 18 or above) of both sexes
  • Ischemic or non-ischemic cause of heart failure
  • QRS duration > 120 ms, non -LBBB type of conduction disturbance
  • NYHA class III or above
  • Sinus rhythm
  • 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 (eg mechanical aortic valve, severe aortic stenosis and aortic dissection) *The definitions of LBBB (QRS duration ≥130 ms; QS or rS in lead V1; broad R waves in leads I, aVL, V5, or V6; and absent q waves in leads I, V5, and V6).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03356652


Contacts
Contact: Olivia TO (852) 3505 1750 oliviato@cuhk.edu.hk

Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Bryan PY YAN Chinese University of Hong Kong
  Study Documents (Full-Text)

Documents provided by Professor Bryan Ping Yen YAN, Chinese University of Hong Kong:

Publications:

Responsible Party: Professor Bryan Ping Yen YAN, Associate Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03356652     History of Changes
Other Study ID Numbers: CUHK-MAPCRT-1
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Professor Bryan Ping Yen YAN, Chinese University of Hong Kong:
Cardiac resynchronizaton therapy
Electrical activation mapping
Noninvasive
Electrical dyssynchrony

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases