Electrical Activation Mapping Guided Tailor Made Approach for Cardiac Resynchronization Therapy
18 oktober 2021 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Verwacht)
93
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Olivia TO
- Telefoonnummer: (852) 3505 1750
- E-mail: oliviato@cuhk.edu.hk
Studie Locaties
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Hong Kong, Hongkong
- Werving
- The Chinese University of Hong Kong
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Contact:
- Olivia To
- Telefoonnummer: (852) 35051750
- E-mail: oliviato@cuhk.edu.hk
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Onderonderzoeker:
- Joseph YS Chan
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Hoofdonderzoeker:
- Bryan PY Yan
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Onderonderzoeker:
- Gary CP Chan
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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).
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Tailor-made CRT delivery
Patient undergoes acute noninvasive electrical dyssynchrony study with various CRT configurations.
CRT device is then implanted with optimal configuration.
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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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Responder rate of greater than 10% of LV end systolic volume reduction in patients undergoing tailor-made approach of CRT delivery at 6 months.
Tijdsspanne: 6 months
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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.
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6 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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The acute electrical dyssynchrony indices of different methods of CRT delivery.
Tijdsspanne: during procedure
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The acute electrical dyssynchrony indices of different methods of CRT delivery.
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during procedure
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The hemodynamic responses of different methods of CRT delivery.
Tijdsspanne: during procedure
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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.
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during procedure
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Procedure duration of the optimal CRT delivery method
Tijdsspanne: during procedure
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Procedure duration of the optimal CRT delivery method as determined by the best improvement in electrical dyssynchrony indices.
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during procedure
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Implantation success rate of the optimal CRT delivery method
Tijdsspanne: during procedure
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Implantation success rate of the optimal CRT delivery method as determined by the best improvement in electrical dyssynchrony indices.
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during procedure
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Cine images (PA, LAO 300, RAO 300) and Chest X ray (PA view)
Tijdsspanne: during procedure
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Cine images (PA, LAO 300, RAO 300) and Chest X ray (PA view)
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during procedure
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Peri-operative and 6 months follow-up complications rate:
Tijdsspanne: Peri-operative and 6 months
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Peri-operative and 6 months
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Left ventricular systolic and diastolic volume at baseline and 6 months:
Tijdsspanne: baseline and 6 months
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Echocardiogram parameter of left ventricular systolic and diastolic volume at baseline and 6 months.
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baseline and 6 months
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Left ventricular ejection fraction at baseline and 6 months:
Tijdsspanne: baseline and 6 months
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Echocardiogram parameter of left ventricular ejection fraction at baseline and 6 months.
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baseline and 6 months
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Degree of mitral regurgitation at baseline and 6 months:
Tijdsspanne: baseline and 6 months
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Echocardiogram parameter of degree of mitral regurgitation at baseline and 6 months.
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baseline and 6 months
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Strain imaging at baseline and 6 months:
Tijdsspanne: baseline and 6 months
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Echocardiogram parameter of strain imaging at baseline and 6 months.
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baseline and 6 months
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NYHA class
Tijdsspanne: baseline and 6 months
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NYHA class at baseline and 6 months.
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baseline and 6 months
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6 minute hall walk test
Tijdsspanne: baseline and 6 months
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6 minute hall walk test at baseline and 6 months.
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baseline and 6 months
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Quality of life using Minnesota's questionnaire
Tijdsspanne: baseline and 6 months
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Quality of life using Minnesota's questionnaire at baseline and 6 months.
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baseline and 6 months
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Electrical parameters including threshold, sensitivity and lead impedance of pacing leads at implant and 6 months follow-up.
Tijdsspanne: during procedure and 6 months
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Electrical parameters including threshold, sensitivity and lead impedance of pacing leads at implant and 6 months follow-up.
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during procedure and 6 months
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Bryan PY YAN, Chinese University of Hong Kong
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
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- 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.
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- 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.
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- 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.
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- 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.
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- 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.
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- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
8 maart 2018
Primaire voltooiing (Verwacht)
31 augustus 2024
Studie voltooiing (Verwacht)
31 augustus 2024
Studieregistratiedata
Eerst ingediend
8 november 2017
Eerst ingediend dat voldeed aan de QC-criteria
23 november 2017
Eerst geplaatst (Werkelijk)
29 november 2017
Updates van studierecords
Laatste update geplaatst (Werkelijk)
19 oktober 2021
Laatste update ingediend die voldeed aan QC-criteria
18 oktober 2021
Laatst geverifieerd
1 oktober 2021
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CUHK-MAPCRT-1
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Nee
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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