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

NCT03125720 | Completed DMC

• 1 other identifier: FirstNanjingMU001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 14

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.

Conditions

Chronic Heart Failure

Keywords

cardiac resynchronization therapy; chronic heart failure; image fusion-guided implantation; SPECT; venogram

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• CRT response rate

  6-month follow-up

• Changes in LVEF

  6-month follow-up

• Composite clinical response rate

  6-month follow-up

• All-cause mortality and composite clinical endpoints

  6-month follow-up

Study Arms (2)

GUIDED group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Image fusion of SPECT MPI and fluoroscopy venography OTHER

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.

GUIDED group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has signed informed consent
• moderate to severe HF (NYHA Class II, III or IV)
• LVEF ≤35%
• QRS duration ≥130 ms
• sinus rhythm

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Fu Wai Hospital, Beijing, China: collaborator
• Shanghai Zhongshan Hospital: collaborator
• Shanghai Chest Hospital: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• Xijing Hospital: collaborator
• First Affiliated Hospital of Zhejiang University: collaborator
• Sir Run Run Shaw Hospital: collaborator
• First People's Hospital of Hangzhou: collaborator
• Anhui Provincial Hospital: collaborator
• The Affiliated Hospital of Xuzhou Medical University: collaborator
• West China Hospital: collaborator
• The First Affiliated Hospital of Dalian Medical University: collaborator
• General Hospital of Shenyang Military Region: collaborator
• Nanjing Medical University: collaborator
• Subei People's Hospital of Jiangsu Province: collaborator

Study Sites (14)

Anhui Provincial Hospital

Hefei, Anhui, China

Location

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Location

Northern Jiangsu Province People's Hospital

Yangzhou, Jiangsu, China

Location

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Location

The General Hospital of Shenyang Military

Shenyang, Liaoning, China

Location

West China Hospital

Chengdu, Sichuan, China

Location

First Affiliated Hospital,Zhejiang University

Hangzhou, Zhejiang, China

Location

First People's Hospital of Hangzhou

Hangzhou, Zhejiang, China

Location

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

Location

Fu Wai Hospital

Beijing, China

Location

Shanghai Chest Hospital

Shanghai, China

Location

Zhongshan Hospital

Shanghai, China

Location

First Affiliated Hospital Xi'an Jiaotong University

Xi'an, China

Location

Xijing Hospital

Xi'an, China

Location

Related Publications (2)

• 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.

  PMID: 22405632 RESULT

• 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.

  PMID: 25440593 RESULT

Study Officials

• Jiangang Zou, MD,Ph.D

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: April 24, 2017
• Study Start: April 14, 2017
• Primary Completion: December 31, 2024
• Study Completion: May 31, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (14)