Chronic Heart Failure Clinical Trial
— GUIDE-CRTOfficial title:
Image Fusion of SPECT MPI and Fluoroscopy Venography to Guide LV Lead Placement for Improved CRT Response (GUIDE-CRT II)
CRT response will be significantly better using image fusion of SPECT MPI and fluoroscopy venogram to guide LV lead placement at the latest activation segment without scar than standard-of-care implantation.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient has signed informed consent - moderate to severe HF (NYHA Class II, III or IV) - LVEF =35% - QRS duration =130 ms - sinus rhythm Exclusion Criteria: - Patient is under a minimum age requirement (<18 years old) - 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 |
Country | Name | City | State |
---|---|---|---|
China | Fu Wai Hospital | Beijing | |
China | West China Hospital | Chengdu | Sichuan |
China | The First Affiliated Hospital of Dalian Medical University | Dalian | Liaoning |
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 | Anhui Provincial Hospital | Hefei | Anhui |
China | Shanghai Chest Hospital | Shanghai | |
China | Zhongshan Hospital | Shanghai | |
China | The General Hospital of Shenyang Military | Shenyang | Liaoning |
China | First Affiliated Hospital Xi'an Jiaotong University | Xi'an | |
China | Xijing Hospital | Xi'an | |
China | The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu |
China | Northern Jiangsu Province People's Hospital | Yangzhou | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital with Nanjing Medical University | Anhui Provincial Hospital, First Affiliated Hospital of Zhejiang University, First Affiliated Hospital Xi'an Jiaotong University, First People's Hospital of Hangzhou, Fu Wai Hospital, Beijing, China, General Hospital of Shenyang Military Region, Nanjing Medical University, Northern Jiangsu People's Hospital, Shanghai Chest Hospital, Shanghai Zhongshan Hospital, Sir Run Run Shaw Hospital, The Affiliated Hospital of Xuzhou Medical University, The First Affiliated Hospital of Dalian Medical University, West China Hospital, Xijing Hospital |
China,
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in LVESV | Changes in LVESV between baseline and 6-month follow-up (a continuous variable): LVESV will be assessed by echocardiography (Simpson's rule). Changes in LVESV will be compared between the two groups. | 6-month follow-up | |
Secondary | CRT response rate | The proportion of the positive CRT response in each group. A positive CRT response is defined as reduction in LVESV by =15% and/or LVEF increase by =10% at 6-month follow-up as compared to the baseline. | 6-month follow-up | |
Secondary | Changes in LVEF | LVEF will be assessed by echocardiography (Simpson's rule) and compared between the baseline and 6-month follow-up. Changes in LVEF will be compared between the two groups. | 6-month follow-up | |
Secondary | Composite clinical response rate | A positive response is defined as decrease by =1 NYHA class and/or improvement in 6MWD by =10% and/or decrease in QOL score by = 9 points at 6-month follow-up.
NYHA class: Changes in NYHA class at 6-month follow-up as compared to the baseline will be compared between the two groups. 6MWD: Changes in 6MWD at 6-month follow-up as compared to the baseline will be compared between the two groups. QOL: Changes in QOL score at 6-month follow-up as compared to the baseline will be compared between the two groups. |
6-month follow-up | |
Secondary | All-cause mortality and composite clinical endpoints | All-cause mortality,all-cause death and heart failure re-hospitalization by the end of study. | 6-month follow-up |
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