Electrical Activation Mapping Guided Tailor Made Approach for Cardiac Resynchronization Therapy
18 ottobre 2021 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Anticipato)
93
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Olivia TO
- Numero di telefono: (852) 3505 1750
- Email: oliviato@cuhk.edu.hk
Luoghi di studio
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Hong Kong, Hong Kong
- Reclutamento
- The Chinese University of Hong Kong
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Contatto:
- Olivia To
- Numero di telefono: (852) 35051750
- Email: oliviato@cuhk.edu.hk
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Sub-investigatore:
- Joseph YS Chan
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Investigatore principale:
- Bryan PY Yan
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Sub-investigatore:
- Gary CP Chan
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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).
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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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.
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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The acute electrical dyssynchrony indices of different methods of CRT delivery.
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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:
Lasso di tempo: 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:
Lasso di tempo: 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:
Lasso di tempo: 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:
Lasso di tempo: 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:
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Bryan PY YAN, Chinese University of Hong Kong
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
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- 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.
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- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
8 marzo 2018
Completamento primario (Anticipato)
31 agosto 2024
Completamento dello studio (Anticipato)
31 agosto 2024
Date di iscrizione allo studio
Primo inviato
8 novembre 2017
Primo inviato che soddisfa i criteri di controllo qualità
23 novembre 2017
Primo Inserito (Effettivo)
29 novembre 2017
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
19 ottobre 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
18 ottobre 2021
Ultimo verificato
1 ottobre 2021
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CUHK-MAPCRT-1
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
No
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .