Image Fusion of SPECT MPI and Fluoroscopy Venography to Guide LV Lead Placement for Improved CRT Response (GUIDE-CRT II)
NCT ID: NCT03125720
Last Updated: 2025-08-17
Study Results
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Basic Information
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COMPLETED
NA
300 participants
INTERVENTIONAL
2017-04-14
2025-05-31
Brief Summary
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Detailed Description
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Although medical treatment for CHF has achieved considerable progress, prognosis is still poor and mortality is high among end-stage HF patients. Since the 1990s, cardiac resynchronization therapy(CRT) has been applied to treat CHF, a large number of evidence-based medicine has shown that CRT brings great clinical effects; CRT mainly aims at delayed activation of left ventricular(LV) and stimulates LV in advance to restore the inter- and intra-ventricular synchrony. As a result, cardiac function, symptoms and quality of life in CHF patients improved, meanwhile mortality rate also decreases. At present, CRT is recommended in quite a number of CHF patients as class I indication. And yet, approximately 30%-40% of patients did not show response to CRT. Non-response to CRT has become a significant problem that must be solved. In recent years, researchers have tried LV multipoint pacing (MPP), transseptal left ventricular endocardial pacing and MitraClip to get some achievements. But these new techniques and CRT itself have two main failings:(1) Up to now, there is no specific suggestions about whether the patient's myocardium has too severe myocardial fibrosis and scar burden to be fit for CRT.(2)The LV mechanical dysynchronization will influence CRT effects. So far, screening CRT indications is primarily based on QRS morphology and duration on surface electrocardiogram.QRS duration≥120ms represents the presence of electrical dysynchronization, however, electrical dysynchronization is not equal to mechanical dysynchronization. The key point of CRT is to solve the mechanical dysynchronization, so estimating cardiac mechanical dysynchrony is important for predicting the CRT response; In addition, LV lead implantation site also exerts an effect on CRT response. The standard-of-care of LV lead implantation technique now just relays on coronary vein angiography showing the appropriate branch vein. This approach cannot guarantee LV lead is implanted in the latest activation site and the non-scar segment. Therefore, the following two issues are very important: how to evaluate the myocardiac scar and LV mechanical dyssynchronization using an objective, accurate, simple and economic method? and how to explore a new image which can guide LV lead to position at the latest activation and non-scar segment conveniently and accurately during procedure for improving CRT response rate? Myocardial perfusion image-phase analysis technique(MPI-PA) is a new non-invasive method to evaluate LV desynchronization,the latest activation site and myocardial scar burden. In recent years,Henneman MM and Adelstein EC reported PA technique detecting LV systolic desynchronization and LV scar burden influencing on CRT response respectively. Their study showed that the low CRT response is associated with the mild LV dyssynchrony and severe scar burden.The past five years,our center has completed a prospective, randomized, multi-center study of"SPECT guided LV Lead Placement for Incremental Benefits to CRT Efficacy"(GUIDE-CRT).We found that the CRT efficacy in SPECT-Guided group at 6 months after CRT implantation was better than that in standard-of-care implantation group(control group):the reduction in LVESV at 6 months in guided group is much more than that in control group(control 28.2ml vs guided group 48.2ml,P=0.029). The CRT response rate, defined as reduction in LVESV more than 15%, in guided group was 55.8% is higher than 47.8% in control group,but there was no statistic difference between two groups.The guiding mothodology of implanting LV lead in our previous study (GUIDE-CRT) was as following: implanter chose the branch vein to implant LV lead based on the recommended site by MPI-PA. Under this guidance, still much percentage of LV lead did not located in the recommended site. Therefore, in order to further improve the accuracy of SPECT guiding LV lead placement, our present study will use automatic fusion of coronary venogram with SPECT images to guide the implantation of LV lead precisely, and bringing incremental benefits to CRT efficacy.
This new study(GUIDE-CRT II) is a prospective, randomized, multi-center trial. Applying the new image fusion of SPECT MPI and coronary venogram to guide LV lead placement at the recommended optimal position, to achieve the precise localization, to avoid blindness of standard of care implantation methods and to improve response to CRT.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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GUIDED group
Image fusion of SPECT MPI and fluoroscopy venography to guide LV lead placement for improved CRT response in the guided group.
Image fusion of SPECT MPI and fluoroscopy venography
In this study, MPI-Fluoro Fusion tool is used to help the implanting physicians to precisely implant LV lead to the optimal/suboptimal venous segments in the guided group.
Control group
No Image fusion of SPECT MPI and fluoroscopy venography to guide LV lead placement for improved CRT response.
No interventions assigned to this group
Interventions
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Image fusion of SPECT MPI and fluoroscopy venography
In this study, MPI-Fluoro Fusion tool is used to help the implanting physicians to precisely implant LV lead to the optimal/suboptimal venous segments in the guided group.
Eligibility Criteria
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Inclusion Criteria
* moderate to severe HF (NYHA Class II, III or IV)
* LVEF ≤35%
* QRS duration ≥130 ms
* sinus rhythm
Exclusion Criteria
* Patient has mechanical right heart valve
* Patient has experienced unstable angina, acute MI, CABG or PCI within the past 3 months
* Patient is on continuous or intermittent (i.e., more than two infusions per week) intravenous inotropic drug therapy
* Patient known to have chronic permanent atrial arrhythmias (i.e., cases of long-standing atrial fibrillation of greater than 1 year, including those in which cardioversion has not been indicated or attempted).
* Patient is enrolled in any other study
* Patient has a life expectancy of less than 12 months
* Women who are pregnant, or with child-bearing potential and who are not on a form of birth control
* Patient with CRT device implanted previously
* Patient has had a heart transplant
* Patient has third degree AVB with normal cardiac function
18 Years
ALL
No
Sponsors
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Fu Wai Hospital, Beijing, China
OTHER
Shanghai Zhongshan Hospital
OTHER
Shanghai Chest Hospital
OTHER
First Affiliated Hospital Xi'an Jiaotong University
OTHER
Xijing Hospital
OTHER
First Affiliated Hospital of Zhejiang University
OTHER
Sir Run Run Shaw Hospital
OTHER
First People's Hospital of Hangzhou
OTHER
Anhui Provincial Hospital
OTHER_GOV
The Affiliated Hospital of Xuzhou Medical University
OTHER
West China Hospital
OTHER
The First Affiliated Hospital of Dalian Medical University
OTHER
General Hospital of Shenyang Military Region
OTHER
Nanjing Medical University
OTHER
Subei People's Hospital of Jiangsu Province
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
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Principal Investigators
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Jiangang Zou, MD,Ph.D
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital with Nanjing Medical University
Locations
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Anhui Provincial Hospital
Hefei, Anhui, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Northern Jiangsu Province People's Hospital
Yangzhou, Jiangsu, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
The General Hospital of Shenyang Military
Shenyang, Liaoning, China
West China Hospital
Chengdu, Sichuan, China
First Affiliated Hospital,Zhejiang University
Hangzhou, Zhejiang, China
First People's Hospital of Hangzhou
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
Fu Wai Hospital
Beijing, , China
Shanghai Chest Hospital
Shanghai, , China
Zhongshan Hospital
Shanghai, , China
First Affiliated Hospital Xi'an Jiaotong University
Xi'an, , China
Xijing Hospital
Xi'an, , China
Countries
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References
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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.
Zhou W, Hou X, Piccinelli M, Tang X, Tang L, Cao K, Garcia EV, Zou J, Chen J. 3D fusion of LV venous anatomy on fluoroscopy venograms with epicardial surface on SPECT myocardial perfusion images for guiding CRT LV lead placement. JACC Cardiovasc Imaging. 2014 Dec;7(12):1239-48. doi: 10.1016/j.jcmg.2014.09.002. Epub 2014 Nov 5.
Other Identifiers
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FirstNanjingMU001
Identifier Type: -
Identifier Source: org_study_id
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