Using advanced imaging to improve heart lead placement for better heart failure treatment

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

This study is testing a new way to place heart leads using advanced imaging to see if it helps people with chronic heart failure respond better to treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (other)
• Locations: 14 sites (Hefei, Anhui and 13 other locations)
• Trial ID: NCT03125720 on ClinicalTrials.gov

What this trial studies

This study aims to enhance the effectiveness of cardiac resynchronization therapy (CRT) in patients with chronic heart failure by utilizing image fusion of SPECT MPI and fluoroscopy venography to guide the placement of left ventricular leads. The approach focuses on targeting the latest activation segment of the heart without scar tissue, which is expected to improve patient response to CRT. Given the high percentage of non-responders to standard CRT methods, this innovative technique could potentially address a significant gap in treatment efficacy. The study will involve patients with moderate to severe heart failure and will assess the outcomes of this advanced imaging-guided implantation method.

Who should consider this trial

Good fit: Ideal candidates for this study are patients with moderate to severe heart failure (NYHA Class II, III, or IV) and a left ventricular ejection fraction (LVEF) of 35% or less.

Not a fit: Patients who have previously had a CRT device implanted or those with certain heart conditions, such as chronic permanent atrial arrhythmias, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the response rates to CRT in patients with chronic heart failure.

How similar studies have performed: While there have been advancements in CRT techniques, this specific image fusion-guided approach is relatively novel and has not been extensively tested in prior studies.

Eligibility 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

Where this trial is running

Hefei, Anhui and 13 other locations

• Anhui Provincial Hospital — Hefei, Anhui, China (RECRUITING)
• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (RECRUITING)
• Northern Jiangsu Province People's Hospital — Yangzhou, Jiangsu, China (RECRUITING)
• The First Affiliated Hospital of Dalian Medical University — Dalian, Liaoning, China (RECRUITING)
• The General Hospital of Shenyang Military — Shenyang, Liaoning, China (RECRUITING)
• West China Hospital — Chengdu, Sichuan, China (RECRUITING)
• First Affiliated Hospital,Zhejiang University — Hangzhou, Zhejiang, China (RECRUITING)
• First People's Hospital of Hangzhou — Hangzhou, Zhejiang, China (RECRUITING)
• Sir Run Run Shaw Hospital — Hangzhou, Zhejiang, China (RECRUITING)
• Fu Wai Hospital — Beijing, China (RECRUITING)
• Shanghai Chest Hospital — Shanghai, China (RECRUITING)
• Zhongshan Hospital — Shanghai, China (RECRUITING)
• First Affiliated Hospital Xi'an Jiaotong University — Xi'an, China (RECRUITING)
• Xijing Hospital — Xi'an, China (RECRUITING)

Study contacts

• Principal investigator: Jiangang Zou, MD,Ph.D — The First Affiliated Hospital with Nanjing Medical University
• Study coordinator: Jiangang Zou, MD,Ph.D

Conditions: Chronic Heart Failure, cardiac resynchronization therapy, chronic heart failure, image fusion-guided implantation, SPECT, venogram