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Trial record 2 of 109 for:    guide | heart failure

Image Fusion of SPECT MPI and Fluoroscopy Venography to Guide LV Lead Placement for Improved CRT Response (GUIDE-CRT II) (GUIDE-CRT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03125720
Recruitment Status : Unknown
Verified April 2017 by The First Affiliated Hospital with Nanjing Medical University.
Recruitment status was:  Recruiting
First Posted : April 24, 2017
Last Update Posted : April 24, 2017
Sponsor:
Collaborators:
Fu Wai Hospital, Beijing, China
Shanghai Zhongshan Hospital
Shanghai Chest Hospital
First Affiliated Hospital Xi'an Jiaotong University
Xijing Hospital
First Affiliated Hospital,Zhejiang University
Sir Run Run Shaw Hospital
First People's Hospital of Hangzhou
Anhui Provincial Hospital
The Affiliated Hospital of Xuzhou Medical University
Northern Jiangsu Province People's Hospital
West China Hospital
The First Affiliated Hospital of Dalian Medical University
The General Hospital of Shenyang Military
Nanjing Medical University
Information provided by (Responsible Party):
The First Affiliated Hospital with Nanjing Medical University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Other: Image fusion of SPECT MPI and fluoroscopy venography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Image Fusion of SPECT MPI and Fluoroscopy Venography to Guide LV Lead Placement for Improved CRT Response (GUIDE-CRT II)
Actual Study Start Date : April 14, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: GUIDED group
Image fusion of SPECT MPI and fluoroscopy venography to guide LV lead placement for improved CRT response in the guided group.
Other: 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.

No Intervention: Control group
No Image fusion of SPECT MPI and fluoroscopy venography to guide LV lead placement for improved CRT response.



Primary Outcome Measures :
  1. Changes in LVESV [ Time Frame: 6-month follow-up ]
    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.


Secondary Outcome Measures :
  1. CRT response rate [ Time Frame: 6-month follow-up ]
    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.

  2. Changes in LVEF [ Time Frame: 6-month follow-up ]
    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.

  3. Composite clinical response rate [ Time Frame: 6-month follow-up ]

    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.

  4. All-cause mortality and composite clinical endpoints [ Time Frame: 6-month follow-up ]
    All-cause mortality,all-cause death and heart failure re-hospitalization by the end of study.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03125720


Contacts
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Contact: Jiangang Zou, MD,Ph.D 86-25-13605191407 jgzou@njmu.edu.cn

Locations
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China, Anhui
Anhui Provincial Hospital Recruiting
Hefei, Anhui, China
Contact: Ji Yan, MD,Ph.D         
Principal Investigator: Ji Yan, MD,Ph.D         
China, Jiangsu
The Affiliated Hospital of Xuzhou Medical University Recruiting
Xuzhou, Jiangsu, China
Contact: Zhirong Wang, MD,Ph.D         
Principal Investigator: Zhirong Wang, MD,Ph.D         
Northern Jiangsu Province People's Hospital Recruiting
Yangzhou, Jiangsu, China
Contact: Xiang Gu, MD,Ph.D         
Principal Investigator: Xiang Gu, MD,Ph.D         
China, Liaoning
The First Affiliated Hospital of Dalian Medical University Recruiting
Dalian, Liaoning, China
Contact: Yunlong Xia, MD,Ph.D         
Principal Investigator: Yunlong Xia, MD,Ph.D         
The General Hospital of Shenyang Military Recruiting
Shenyang, Liaoning, China
Contact: Yanchun Liang, MD,Ph.D         
Principal Investigator: Yanchun Liang, MD,Ph.D         
China, Sichuan
West China Hospital Recruiting
Chengdu, Sichuan, China
Contact: Xingbin Liu, MD,Ph.D         
Principal Investigator: Xingbin Liu, MD,Ph.D         
China, Zhejiang
First Affiliated Hospital,Zhejiang University Recruiting
Hangzhou, Zhejiang, China
Contact: Liangrong Zheng, MD,Ph.D         
Principal Investigator: Liangrong Zheng, MD,Ph.D         
First People's Hospital of Hangzhou Recruiting
Hangzhou, Zhejiang, China
Contact: Yizhou Xu, MD,Ph.D         
Principal Investigator: Yizhou Xu, MD,Ph.D         
Sir Run Run Shaw Hospital Recruiting
Hangzhou, Zhejiang, China
Contact: Guosheng Fu, MD,Ph.D         
Principal Investigator: Guosheng Fu, MD,Ph.D         
China
Fu Wai Hospital Recruiting
Beijing, China
Contact: Keping Chen, MD,Ph.D         
Principal Investigator: Keping Chen, MD,Ph.D         
Principal Investigator: Xiaohan Fan, MD,Ph.D         
Principal Investigator: Wei Hua, MD,Ph.D         
Shanghai Chest Hospital Recruiting
Shanghai, China
Contact: Ruogu Li, MD,Ph.D         
Principal Investigator: Ruogu Li, MD,Ph.D         
Zhongshan Hospital Recruiting
Shanghai, China
Contact: Yangang Su, MD,Ph.D         
Principal Investigator: Yangang Su, MD,Ph.D         
First Affiliated Hospital Xi'an Jiaotong University Recruiting
Xi'an, China
Contact: Xiaolin Xue, MD,Ph.D         
Principal Investigator: Xiaolin Xue, MD,Ph.D         
Xijing Hospital Recruiting
Xi'an, China
Contact: Bing Liu, MD,Ph.D         
Principal Investigator: Bing Liu, MD,Ph.D         
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Fu Wai Hospital, Beijing, China
Shanghai Zhongshan Hospital
Shanghai Chest Hospital
First Affiliated Hospital Xi'an Jiaotong University
Xijing Hospital
First Affiliated Hospital,Zhejiang University
Sir Run Run Shaw Hospital
First People's Hospital of Hangzhou
Anhui Provincial Hospital
The Affiliated Hospital of Xuzhou Medical University
Northern Jiangsu Province People's Hospital
West China Hospital
The First Affiliated Hospital of Dalian Medical University
The General Hospital of Shenyang Military
Nanjing Medical University
Investigators
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Principal Investigator: Jiangang Zou, MD,Ph.D The First Affiliated Hospital with Nanjing Medical University
Publications of Results:
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Responsible Party: The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03125720    
Other Study ID Numbers: FirstNanjingMU001
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: April 24, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The First Affiliated Hospital with Nanjing Medical University:
cardiac resynchronization therapy
chronic heart failure
image fusion-guided implantation
SPECT
venogram
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases