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Heart FailureNCT03356652

Electrical Activation Mapping Guided Tailor Made Approach for Cardiac Resynchronization Therapy

A study testing Noninvasive electrical dyssynchrony study 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 The sponsor has not verified this record for over two years, so it may be out of date.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, a good response is observed in less than 40% in patient receiving CRT. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Heart Failure
What is being tested?
Noninvasive electrical dyssynchrony study
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
1 siteHong Kong
Study dates
8 Mar 2018to 31 Aug 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
  • Healthy volunteers accepted
  • 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 -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

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Olivia TO contact

(852) 3505 1750

oliviato@cuhk.edu.hk

Hong Kong1 site, 1 recruiting

  • The Chinese University of Hong Kong

    Hong Kong

    Olivia To, (852) 35051750, oliviato@cuhk.edu.hk

    Joseph YS Chan

    Recruiting

Other trials in Hong Kong

About this study

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.

Read more

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.

Read the 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.

Conditions
Heart Failure
Being tested
Noninvasive electrical dyssynchrony study
Keywords
Cardiac resynchronizaton therapy, Electrical activation mapping, Noninvasive, Electrical dyssynchrony
Medical subject headings
Heart Failure

What participants receive

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

  • Noninvasive electrical dyssynchrony studyProcedure or surgery

    Also called Noninvasive electrical activation, Electrical Activation Mapping, Noninvasive mapping system, ECVUE

    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.

Study groups in NCT03356652
Study groupRoleWhat they receive
Tailor-made CRT deliveryExperimentalPatient undergoes acute noninvasive electrical dyssynchrony study with various CRT configurations. CRT device is then implanted with optimal configuration.
Receives: Procedure: Noninvasive electrical dyssynchrony study

What is being measured

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

  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.

    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.

    Measured: 6 months

Secondary outcomes (14)

  1. The acute electrical dyssynchrony indices of different methods of CRT delivery.

    The acute electrical dyssynchrony indices of different methods of CRT delivery.

    Measured: during procedure

  2. The hemodynamic responses of different methods of CRT delivery.

    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.

    Measured: during procedure

  3. Procedure duration of the optimal CRT delivery method

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

    Measured: during procedure

  4. Implantation success rate of the optimal CRT delivery method

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

    Measured: during procedure

  5. Cine images (PA, LAO 300, RAO 300) and Chest X ray (PA view)

    Cine images (PA, LAO 300, RAO 300) and Chest X ray (PA view)

    Measured: during procedure

  6. 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: Peri-operative and 6 months

  7. Left ventricular systolic and diastolic volume at baseline and 6 months:

    Echocardiogram parameter of left ventricular systolic and diastolic volume at baseline and 6 months.

    Measured: baseline and 6 months

  8. Left ventricular ejection fraction at baseline and 6 months:

    Echocardiogram parameter of left ventricular ejection fraction at baseline and 6 months.

    Measured: baseline and 6 months

  9. Degree of mitral regurgitation at baseline and 6 months:

    Echocardiogram parameter of degree of mitral regurgitation at baseline and 6 months.

    Measured: baseline and 6 months

  10. Strain imaging at baseline and 6 months:

    Echocardiogram parameter of strain imaging at baseline and 6 months.

    Measured: baseline and 6 months

  11. NYHA class

    NYHA class at baseline and 6 months.

    Measured: baseline and 6 months

  12. 6 minute hall walk test

    6 minute hall walk test at baseline and 6 months.

    Measured: baseline and 6 months

  13. Quality of life using Minnesota's questionnaire

    Quality of life using Minnesota's questionnaire at baseline and 6 months.

    Measured: baseline and 6 months

  14. Electrical parameters including threshold, sensitivity and lead impedance of pacing leads at implant and 6 months follow-up.

    Electrical parameters including threshold, sensitivity and lead impedance of pacing leads at implant and 6 months follow-up.

    Measured: during procedure and 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 posted29 Nov 2017
  2. Study start8 Mar 2018
  3. Primary completion31 Aug 2024 (estimated)
  4. Study completion31 Aug 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
93 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03356652
Sponsor's protocol ID
CUHK-MAPCRT-1
Status last verified
Oct 2021
First submitted
8 Nov 2017
Last updated
19 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bristow MR, Saxon LA, Boehmer J, Krueger S, Kass DA, De Marco T, Carson P, DiCarlo L, DeMets D, White BG, DeVries DW, Feldman AM; Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Investigators. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med. 2004 May 20;350(21):2140-50. doi: 10.1056/NEJMoa032423.

    PubMed 15152059

  • Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, Tavazzi L; Cardiac Resynchronization-Heart Failure (CARE-HF) Study Investigators. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med. 2005 Apr 14;352(15):1539-49. doi: 10.1056/NEJMoa050496. Epub 2005 Mar 7.

    PubMed 15753115

  • Tang AS, Wells GA, Talajic M, Arnold MO, Sheldon R, Connolly S, Hohnloser SH, Nichol G, Birnie DH, Sapp JL, Yee R, Healey JS, Rouleau JL; Resynchronization-Defibrillation for Ambulatory Heart Failure Trial Investigators. Cardiac-resynchronization therapy for mild-to-moderate heart failure. N Engl J Med. 2010 Dec 16;363(25):2385-95. doi: 10.1056/NEJMoa1009540. Epub 2010 Nov 14.

    PubMed 21073365

  • Bradley DJ, Bradley EA, Baughman KL, Berger RD, Calkins H, Goodman SN, Kass DA, Powe NR. Cardiac resynchronization and death from progressive heart failure: a meta-analysis of randomized controlled trials. JAMA. 2003 Feb 12;289(6):730-40. doi: 10.1001/jama.289.6.730.

    PubMed 12585952

  • Cleland JG, Abraham WT, Linde C, Gold MR, Young JB, Claude Daubert J, Sherfesee L, Wells GA, Tang AS. An individual patient meta-analysis of five randomized trials assessing the effects of cardiac resynchronization therapy on morbidity and mortality in patients with symptomatic heart failure. Eur Heart J. 2013 Dec;34(46):3547-56. doi: 10.1093/eurheartj/eht290. Epub 2013 Jul 29.

    PubMed 23900696

  • European Society of Cardiology (ESC); European Heart Rhythm Association (EHRA); Brignole M, Auricchio A, Baron-Esquivias G, Bordachar P, Boriani G, Breithardt OA, Cleland J, Deharo JC, Delgado V, Elliott PM, Gorenek B, Israel CW, Leclercq C, Linde C, Mont L, Padeletti L, Sutton R, Vardas PE. 2013 ESC guidelines on cardiac pacing and cardiac resynchronization therapy: the task force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA). Europace. 2013 Aug;15(8):1070-118. doi: 10.1093/europace/eut206. Epub 2013 Jun 24. No abstract available.

    PubMed 23801827

  • Russo AM, Stainback RF, Bailey SR, Epstein AE, Heidenreich PA, Jessup M, Kapa S, Kremers MS, Lindsay BD, Stevenson LW. ACCF/HRS/AHA/ASE/HFSA/SCAI/SCCT/SCMR 2013 appropriate use criteria for implantable cardioverter-defibrillators and cardiac resynchronization therapy: a report of the American College of Cardiology Foundation appropriate use criteria task force, Heart Rhythm Society, American Heart Association, American Society of Echocardiography, Heart Failure Society of America, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, and Society for Cardiovascular Magnetic Resonance. J Am Coll Cardiol. 2013 Mar 26;61(12):1318-68. doi: 10.1016/j.jacc.2012.12.017. Epub 2013 Mar 1. No abstract available.

    PubMed 23453819

  • Sipahi I, Chou JC, Hyden M, Rowland DY, Simon DI, Fang JC. Effect of QRS morphology on clinical event reduction with cardiac resynchronization therapy: meta-analysis of randomized controlled trials. Am Heart J. 2012 Feb;163(2):260-7.e3. doi: 10.1016/j.ahj.2011.11.014.

    PubMed 22305845

  • Peterson PN, Greiner MA, Qualls LG, Al-Khatib SM, Curtis JP, Fonarow GC, Hammill SC, Heidenreich PA, Hammill BG, Piccini JP, Hernandez AF, Curtis LH, Masoudi FA. QRS duration, bundle-branch block morphology, and outcomes among older patients with heart failure receiving cardiac resynchronization therapy. JAMA. 2013 Aug 14;310(6):617-26. doi: 10.1001/jama.2013.8641.

    PubMed 23942680

  • Eschalier R, Ploux S, Ritter P, Haissaguerre M, Ellenbogen KA, Bordachar P. Nonspecific intraventricular conduction delay: Definitions, prognosis, and implications for cardiac resynchronization therapy. Heart Rhythm. 2015 May;12(5):1071-9. doi: 10.1016/j.hrthm.2015.01.023. Epub 2015 Jan 19.

    PubMed 25614250

  • Nery PB, Ha AC, Keren A, Birnie DH. Cardiac resynchronization therapy in patients with left ventricular systolic dysfunction and right bundle branch block: a systematic review. Heart Rhythm. 2011 Jul;8(7):1083-7. doi: 10.1016/j.hrthm.2011.01.041. Epub 2011 Feb 4.

    PubMed 21300176

  • Byrne MJ, Helm RH, Daya S, Osman NF, Halperin HR, Berger RD, Kass DA, Lardo AC. Diminished left ventricular dyssynchrony and impact of resynchronization in failing hearts with right versus left bundle branch block. J Am Coll Cardiol. 2007 Oct 9;50(15):1484-90. doi: 10.1016/j.jacc.2007.07.011. Epub 2007 Sep 24.

    PubMed 17919569

  • Gold MR, Thebault C, Linde C, Abraham WT, Gerritse B, Ghio S, St John Sutton M, Daubert JC. Effect of QRS duration and morphology on cardiac resynchronization therapy outcomes in mild heart failure: results from the Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction (REVERSE) study. Circulation. 2012 Aug 14;126(7):822-9. doi: 10.1161/CIRCULATIONAHA.112.097709. Epub 2012 Jul 10.

    PubMed 22781424

  • Hara H, Oyenuga OA, Tanaka H, Adelstein EC, Onishi T, McNamara DM, Schwartzman D, Saba S, Gorcsan J 3rd. The relationship of QRS morphology and mechanical dyssynchrony to long-term outcome following cardiac resynchronization therapy. Eur Heart J. 2012 Nov;33(21):2680-91. doi: 10.1093/eurheartj/ehs013. Epub 2012 Feb 19.

    PubMed 22351700

  • Haghjoo M, Bagherzadeh A, Farahani MM, Haghighi ZO, Sadr-Ameli MA. Significance of QRS morphology in determining the prevalence of mechanical dyssynchrony in heart failure patients eligible for cardiac resynchronization: particular focus on patients with right bundle branch block with and without coexistent left-sided conduction defects. Europace. 2008 May;10(5):566-71. doi: 10.1093/europace/eun081. Epub 2008 Apr 3.

    PubMed 18390536

Questions about this trial

What is this clinical trial studying?

A study testing Noninvasive electrical dyssynchrony study 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 7 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 19 Oct 2021. 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 Olivia TO ((852) 3505 1750, oliviato@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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. (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 NCT03356652, which also lists 47 linked publications.

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 19 Oct 2021.

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