Diaphragm-synchronized pacing via the left inferior phrenic vein
Official title: Feasibility Study of Diaphragm Synchronized Pacing (DSP) Via the Left Inferior Phrenic Vein (LIPV) Approach
Run by RenJi Hospital · NCT07392749 · Data updated 2026-11-12
This trial will try diaphragm-synchronized pacing through the left inferior phrenic vein to see if it helps adults with heart failure who are scheduled for CRT or CRT-D implantation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | RenJi Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | November 28, 2025 |
| Main results expected | February 28, 2026 |
| Study ends | March 31, 2026 |
| Registry record updated | February 6, 2026 |
| Trial ID | NCT07392749 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) who are indicated for CRT or CRT-D and are scheduled for LV lead implantation, without diaphragm or phrenic nerve problems and willing to consent, are the ideal candidates.
✕Probably not a fit
Patients with prior CABG, diaphragm dysfunction or phrenic nerve injury, significant pulmonary disease, history of IVC filter or major abdominal surgery, or severe liver/kidney dysfunction are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-site, acute interventional feasibility trial at Renji Hospital enrolling 10 adults who are indicated for CRT or CRT-D and planned for LV lead implantation. Investigators will deliver diaphragm-synchronized pacing (DSP) via the left inferior phrenic vein during the interventional procedure and monitor immediate physiological effects. The study will collect safety data and short-term measures of cardiac function and quality of life, with one-week follow-up after discharge. Key exclusions include prior CABG, diaphragm or phrenic nerve dysfunction, significant pulmonary disease, major abdominal surgery, IVC filter, and severe hepatic or renal dysfunction.
Why it matters
Potential benefit: If successful, this approach could augment heart pump function and improve symptoms and quality of life by using timed diaphragm contractions to support cardiac systole and/or diastole.
How similar studies have gone: This application of synchronized diaphragm pacing for heart failure is relatively novel—diaphragm pacing has established use in respiratory conditions but there is limited prior clinical evidence for improving cardiac pump function.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged \>=18 yrs; * Patients indicated for CRT or CRT-D , planned for LV lead implantation; * Patients are willing to participate in the study and provide signed informed consent Exclusion Criteria: * CRT or CRT-D replacement * Ischemic heart disease with CABG history * Diaphragm dysfunction history * Phrenic nerve injury * IVC filter history * Abdominal surgery history * Splenomegaly * Pulmonary disease * Moderate or severe liver cirrhosis * Severe hepatic or renal dysfunction * Currently pregnant or planning pregnancy during the study period * Patients participate in another study that will confound this study
Where it's running
-
Renji Hospital
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Tianbao Dr. Yao, MD
- Email: yaotianbao@renji.com
- Phone: +86 13661684786
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.