Electrical Activation Mapping Guided Tailor Made Approach for Cardiac Resynchronization Therapy
18 de outubro de 2021 atualizado por: Professor Bryan Ping Yen YAN, Chinese University of Hong Kong
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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Antecipado)
93
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Olivia TO
- Número de telefone: (852) 3505 1750
- E-mail: oliviato@cuhk.edu.hk
Locais de estudo
-
-
-
Hong Kong, Hong Kong
- Recrutamento
- The Chinese University of Hong Kong
-
Contato:
- Olivia To
- Número de telefone: (852) 35051750
- E-mail: oliviato@cuhk.edu.hk
-
Subinvestigador:
- Joseph YS Chan
-
Investigador principal:
- Bryan PY Yan
-
Subinvestigador:
- Gary CP Chan
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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).
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Tailor-made CRT delivery
Patient undergoes acute noninvasive electrical dyssynchrony study with various CRT configurations.
CRT device is then implanted with optimal configuration.
|
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.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Responder rate of greater than 10% of LV end systolic volume reduction in patients undergoing tailor-made approach of CRT delivery at 6 months.
Prazo: 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.
|
6 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The acute electrical dyssynchrony indices of different methods of CRT delivery.
Prazo: during procedure
|
The acute electrical dyssynchrony indices of different methods of CRT delivery.
|
during procedure
|
|
The hemodynamic responses of different methods of CRT delivery.
Prazo: 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.
|
during procedure
|
|
Procedure duration of the optimal CRT delivery method
Prazo: during procedure
|
Procedure duration of the optimal CRT delivery method as determined by the best improvement in electrical dyssynchrony indices.
|
during procedure
|
|
Implantation success rate of the optimal CRT delivery method
Prazo: during procedure
|
Implantation success rate of the optimal CRT delivery method as determined by the best improvement in electrical dyssynchrony indices.
|
during procedure
|
|
Cine images (PA, LAO 300, RAO 300) and Chest X ray (PA view)
Prazo: during procedure
|
Cine images (PA, LAO 300, RAO 300) and Chest X ray (PA view)
|
during procedure
|
|
Peri-operative and 6 months follow-up complications rate:
Prazo: Peri-operative and 6 months
|
|
Peri-operative and 6 months
|
|
Left ventricular systolic and diastolic volume at baseline and 6 months:
Prazo: baseline and 6 months
|
Echocardiogram parameter of left ventricular systolic and diastolic volume at baseline and 6 months.
|
baseline and 6 months
|
|
Left ventricular ejection fraction at baseline and 6 months:
Prazo: baseline and 6 months
|
Echocardiogram parameter of left ventricular ejection fraction at baseline and 6 months.
|
baseline and 6 months
|
|
Degree of mitral regurgitation at baseline and 6 months:
Prazo: baseline and 6 months
|
Echocardiogram parameter of degree of mitral regurgitation at baseline and 6 months.
|
baseline and 6 months
|
|
Strain imaging at baseline and 6 months:
Prazo: baseline and 6 months
|
Echocardiogram parameter of strain imaging at baseline and 6 months.
|
baseline and 6 months
|
|
NYHA class
Prazo: baseline and 6 months
|
NYHA class at baseline and 6 months.
|
baseline and 6 months
|
|
6 minute hall walk test
Prazo: baseline and 6 months
|
6 minute hall walk test at baseline and 6 months.
|
baseline and 6 months
|
|
Quality of life using Minnesota's questionnaire
Prazo: baseline and 6 months
|
Quality of life using Minnesota's questionnaire at baseline and 6 months.
|
baseline and 6 months
|
|
Electrical parameters including threshold, sensitivity and lead impedance of pacing leads at implant and 6 months follow-up.
Prazo: during procedure and 6 months
|
Electrical parameters including threshold, sensitivity and lead impedance of pacing leads at implant and 6 months follow-up.
|
during procedure and 6 months
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Bryan PY YAN, Chinese University of Hong Kong
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
- Chung ES, Leon AR, Tavazzi L, Sun JP, Nihoyannopoulos P, Merlino J, Abraham WT, Ghio S, Leclercq C, Bax JJ, Yu CM, Gorcsan J 3rd, St John Sutton M, De Sutter J, Murillo J. Results of the Predictors of Response to CRT (PROSPECT) trial. Circulation. 2008 May 20;117(20):2608-16. doi: 10.1161/CIRCULATIONAHA.107.743120. Epub 2008 May 5.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Ghosh S, Silva JN, Canham RM, Bowman TM, Zhang J, Rhee EK, Woodard PK, Rudy Y. Electrophysiologic substrate and intraventricular left ventricular dyssynchrony in nonischemic heart failure patients undergoing cardiac resynchronization therapy. Heart Rhythm. 2011 May;8(5):692-9. doi: 10.1016/j.hrthm.2011.01.017. Epub 2011 Jan 11.
- Ploux S, Eschalier R, Whinnett ZI, Lumens J, Derval N, Sacher F, Hocini M, Jais P, Dubois R, Ritter P, Haissaguerre M, Wilkoff BL, Francis DP, Bordachar P. Electrical dyssynchrony induced by biventricular pacing: implications for patient selection and therapy improvement. Heart Rhythm. 2015 Apr;12(4):782-91. doi: 10.1016/j.hrthm.2014.12.031. Epub 2014 Dec 26.
- Ploux S, Lumens J, Whinnett Z, Montaudon M, Strom M, Ramanathan C, Derval N, Zemmoura A, Denis A, De Guillebon M, Shah A, Hocini M, Jais P, Ritter P, Haissaguerre M, Wilkoff BL, Bordachar P. Noninvasive electrocardiographic mapping to improve patient selection for cardiac resynchronization therapy: beyond QRS duration and left bundle branch block morphology. J Am Coll Cardiol. 2013 Jun 18;61(24):2435-2443. doi: 10.1016/j.jacc.2013.01.093. Epub 2013 Apr 16.
- Auricchio A, Fantoni C, Regoli F, Carbucicchio C, Goette A, Geller C, Kloss M, Klein H. Characterization of left ventricular activation in patients with heart failure and left bundle-branch block. Circulation. 2004 Mar 9;109(9):1133-9. doi: 10.1161/01.CIR.0000118502.91105.F6. Epub 2004 Mar 1.
- Auricchio A, Lumens J, Prinzen FW. Does cardiac resynchronization therapy benefit patients with right bundle branch block: cardiac resynchronization therapy has a role in patients with right bundle branch block. Circ Arrhythm Electrophysiol. 2014 Jun;7(3):532-42. doi: 10.1161/CIRCEP.113.000628. No abstract available.
- Varma N, Jia P, Rudy Y. Electrocardiographic imaging of patients with heart failure with left bundle branch block and response to cardiac resynchronization therapy. J Electrocardiol. 2007 Nov-Dec;40(6 Suppl):S174-8. doi: 10.1016/j.jelectrocard.2007.06.017.
- Lund LH, Jurga J, Edner M, Benson L, Dahlstrom U, Linde C, Alehagen U. Prevalence, correlates, and prognostic significance of QRS prolongation in heart failure with reduced and preserved ejection fraction. Eur Heart J. 2013 Feb;34(7):529-39. doi: 10.1093/eurheartj/ehs305. Epub 2012 Oct 4.
- Khan FZ, Virdee MS, Palmer CR, Pugh PJ, O'Halloran D, Elsik M, Read PA, Begley D, Fynn SP, Dutka DP. Targeted left ventricular lead placement to guide cardiac resynchronization therapy: the TARGET study: a randomized, controlled trial. J Am Coll Cardiol. 2012 Apr 24;59(17):1509-18. doi: 10.1016/j.jacc.2011.12.030. Epub 2012 Mar 7.
- Gold MR, Birgersdotter-Green U, Singh JP, Ellenbogen KA, Yu Y, Meyer TE, Seth M, Tchou PJ. The relationship between ventricular electrical delay and left ventricular remodelling with cardiac resynchronization therapy. Eur Heart J. 2011 Oct;32(20):2516-24. doi: 10.1093/eurheartj/ehr329. Epub 2011 Aug 29.
- Lustgarten DL, Crespo EM, Arkhipova-Jenkins I, Lobel R, Winget J, Koehler J, Liberman E, Sheldon T. His-bundle pacing versus biventricular pacing in cardiac resynchronization therapy patients: A crossover design comparison. Heart Rhythm. 2015 Jul;12(7):1548-57. doi: 10.1016/j.hrthm.2015.03.048. Epub 2015 Mar 28.
- Anselme F, Bordachar P, Pasquie JL, Klug D, Leclercq C, Milhem A, Alonso C, Deharo JC, Gras D, Probst V, Piot O, Savoure A. Safety, feasibility, and outcome results of cardiac resynchronization with triple-site ventricular stimulation compared to conventional cardiac resynchronization. Heart Rhythm. 2016 Jan;13(1):183-9. doi: 10.1016/j.hrthm.2015.08.036. Epub 2015 Sep 26.
- Lenarczyk R, Kowalski O, Sredniawa B, Pruszkowska-Skrzep P, Mazurek M, Jedrzejczyk-Patej E, Wozniak A, Pluta S, Glowacki J, Kalarus Z. Implantation feasibility, procedure-related adverse events and lead performance during 1-year follow-up in patients undergoing triple-site cardiac resynchronization therapy: a substudy of TRUST CRT randomized trial. J Cardiovasc Electrophysiol. 2012 Nov;23(11):1228-36. doi: 10.1111/j.1540-8167.2012.02375.x. Epub 2012 May 31.
- Bordachar P, Alonso C, Anselme F, Boveda S, Defaye P, Garrigue S, Gras D, Klug D, Piot O, Sadoul N, Leclercq C. Addition of a second LV pacing site in CRT nonresponders rationale and design of the multicenter randomized V(3) trial. J Card Fail. 2010 Sep;16(9):709-13. doi: 10.1016/j.cardfail.2010.04.010. Epub 2010 Jun 8.
- Morgan JM, Biffi M, Geller L, Leclercq C, Ruffa F, Tung S, Defaye P, Yang Z, Gerritse B, van Ginneken M, Yee R, Jais P; ALSYNC Investigators. ALternate Site Cardiac ResYNChronization (ALSYNC): a prospective and multicentre study of left ventricular endocardial pacing for cardiac resynchronization therapy. Eur Heart J. 2016 Jul 14;37(27):2118-27. doi: 10.1093/eurheartj/ehv723. Epub 2016 Jan 18.
- Fang F, Zhang Q, Chan JY, Razali O, Azlan H, Chan HC, Sanderson JE, Xie JM, Yu CM. Early pacing-induced systolic dyssynchrony is a strong predictor of left ventricular adverse remodeling: analysis from the Pacing to Avoid Cardiac Enlargement (PACE) trial. Int J Cardiol. 2013 Sep 30;168(2):723-8. doi: 10.1016/j.ijcard.2012.08.005. Epub 2012 Sep 1.
- Zhang Q, van Bommel RJ, Chan YS, Delgado V, Liang Y, Schalij MJ, Bax JJ, Fang F, Wai-Kwok Yip G, Yu CM. Diverse patterns of longitudinal and radial dyssynchrony in patients with advanced systolic heart failure. Heart. 2011 Apr;97(7):574-8. doi: 10.1136/hrt.2010.198572. Epub 2011 Jan 30.
- Fang F, Chan JY, Yip GW, Xie JM, Zhang Q, Fung JW, Lam YY, Yu CM. Prevalence and determinants of left ventricular systolic dyssynchrony in patients with normal ejection fraction received right ventricular apical pacing: a real-time three-dimensional echocardiographic study. Eur J Echocardiogr. 2010 Mar;11(2):109-18. doi: 10.1093/ejechocard/jep171. Epub 2009 Nov 20.
- Zhang Q, van Bommel RJ, Fung JW, Chan JY, Bleeker GB, Ypenburg C, Yip G, Liang YJ, Schalij MJ, Bax JJ, Yu CM. Tissue Doppler velocity is superior to strain imaging in predicting long-term cardiovascular events after cardiac resynchronisation therapy. Heart. 2009 Jul;95(13):1085-90. doi: 10.1136/hrt.2008.161653. Epub 2009 Apr 9.
- Zhang Q, Fang F, Yip GW, Chan JY, Shang Q, Fung JW, Chan AK, Liang YJ, Yu CM. Difference in prevalence and pattern of mechanical dyssynchrony in left bundle branch block occurring in right ventricular apical pacing versus systolic heart failure. Am Heart J. 2008 Nov;156(5):989-95. doi: 10.1016/j.ahj.2008.06.027. Epub 2008 Sep 11.
- Fung JW, Lam YY, Zhang Q, Yip GW, Chan WW, Chan GC, Chan JY, Yu CM. Effect of left ventricular lead concordance to the delayed contraction segment on echocardiographic and clinical outcomes after cardiac resynchronization therapy. J Cardiovasc Electrophysiol. 2009 May;20(5):530-5. doi: 10.1111/j.1540-8167.2008.01364.x. Epub 2008 Nov 21.
- Zhang Y, Yip GW, Chan AK, Wang M, Lam WW, Fung JW, Chan JY, Sanderson JE, Yu CM. Left ventricular systolic dyssynchrony is a predictor of cardiac remodeling after myocardial infarction. Am Heart J. 2008 Dec;156(6):1124-32. doi: 10.1016/j.ahj.2008.07.019. Epub 2008 Oct 26.
- Zhang Q, Fung JW, Chan JY, Yip G, Lam YY, Liang YJ, Yu CM. Difference in long-term clinical outcome after cardiac resynchronisation therapy between ischaemic and non-ischaemic aetiologies of heart failure. Heart. 2009 Feb;95(2):113-8. doi: 10.1136/hrt.2008.145698. Epub 2008 Jul 24.
- Zhang Q, Fung JW, Yip GW, Chan JY, Lee AP, Lam YY, Wu LW, Wu EB, Yu CM. Improvement of left ventricular myocardial short-axis, but not long-axis function or torsion after cardiac resynchronisation therapy: an assessment by two-dimensional speckle tracking. Heart. 2008 Nov;94(11):1464-71. doi: 10.1136/hrt.2007.127498. Epub 2008 Jan 15.
- Van de Veire NR, Yu CM, Ajmone-Marsan N, Bleeker GB, Ypenburg C, De Sutter J, Zhang Q, Fung JW, Chan JY, Holman ER, van der Wall EE, Schalij MJ, Bax JJ. Triplane tissue Doppler imaging: a novel three-dimensional imaging modality that predicts reverse left ventricular remodelling after cardiac resynchronisation therapy. Heart. 2008 Mar;94(3):e9. doi: 10.1136/hrt.2007.122564. Epub 2007 Nov 5.
- Yu CM, Gorcsan J 3rd, Bleeker GB, Zhang Q, Schalij MJ, Suffoletto MS, Fung JW, Schwartzman D, Chan YS, Tanabe M, Bax JJ. Usefulness of tissue Doppler velocity and strain dyssynchrony for predicting left ventricular reverse remodeling response after cardiac resynchronization therapy. Am J Cardiol. 2007 Oct 15;100(8):1263-70. doi: 10.1016/j.amjcard.2007.05.060. Epub 2007 Aug 20.
- Fung JW, Chan JY, Yip GW, Chan HC, Chan WW, Zhang Q, Yu CM. Effect of left ventricular endocardial activation pattern on echocardiographic and clinical response to cardiac resynchronization therapy. Heart. 2007 Apr;93(4):432-7. doi: 10.1136/hrt.2007.115295. Epub 2007 Jan 19.
- Yu CM, Chan YS, Zhang Q, Yip GW, Chan CK, Kum LC, Wu L, Lee AP, Lam YY, Fung JW. Benefits of cardiac resynchronization therapy for heart failure patients with narrow QRS complexes and coexisting systolic asynchrony by echocardiography. J Am Coll Cardiol. 2006 Dec 5;48(11):2251-7. doi: 10.1016/j.jacc.2006.07.054.
- Yu CM, Zhang Q, Yip GW, Chan YS, Lee PW, Wu LW, Lam YY, Kum LC, Chan HC, Chan S, Fung JW. Are left ventricular diastolic function and diastolic asynchrony important determinants of response to cardiac resynchronization therapy? Am J Cardiol. 2006 Oct 15;98(8):1083-7. doi: 10.1016/j.amjcard.2006.05.028. Epub 2006 Aug 30.
- Fung JW, Zhang Q, Yip GW, Chan JY, Chan HC, Yu CM. Effect of cardiac resynchronization therapy in patients with moderate left ventricular systolic dysfunction and wide QRS complex: a prospective study. J Cardiovasc Electrophysiol. 2006 Dec;17(12):1288-92. doi: 10.1111/j.1540-8167.2006.00612.x. Epub 2006 Sep 20.
- Yu CM, Zhang Q, Fung JW, Chan HC, Chan YS, Yip GW, Kong SL, Lin H, Zhang Y, Sanderson JE. A novel tool to assess systolic asynchrony and identify responders of cardiac resynchronization therapy by tissue synchronization imaging. J Am Coll Cardiol. 2005 Mar 1;45(5):677-84. doi: 10.1016/j.jacc.2004.12.003.
- Zhang Q, Yu CM, Fung JW, Zhang Y, Chan YS, Chan HC, Yip GW, Sanderson JE. Assessment of the effect of cardiac resynchronization therapy on intraventricular mechanical synchronicity by regional volumetric changes. Am J Cardiol. 2005 Jan 1;95(1):126-9. doi: 10.1016/j.amjcard.2004.08.078.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
8 de março de 2018
Conclusão Primária (Antecipado)
31 de agosto de 2024
Conclusão do estudo (Antecipado)
31 de agosto de 2024
Datas de inscrição no estudo
Enviado pela primeira vez
8 de novembro de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
23 de novembro de 2017
Primeira postagem (Real)
29 de novembro de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
19 de outubro de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
18 de outubro de 2021
Última verificação
1 de outubro de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CUHK-MAPCRT-1
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Não
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .