NCT07392749 Feasibility Study of Diaphragm Synchronized Pacing (DSP) Via the Left Inferior Phrenic Vein (LIPV) Approach
| NCT ID | NCT07392749 |
| Status | Recruiting |
| Phase | — |
| Sponsor | RenJi Hospital |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-11-28 |
| Primary Completion | 2026-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2025-11-28 with a primary completion date of 2026-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Cardiac resynchronization therapy（CRT） benefits a portion of patients, while more patients are not yet indicated to a therapy that mechanically helps the heart systole and/or diastole. Synchronized diaphragmatic pacing may be feasible to induce diaphragm local contraction and recoil that enhance pump function of the heart, thus improve cardiac function and QoL. This acute, interventional study is conducted in a single site, Renji Hospital, to evaluate the feasibility of diaphragm pacing and assess the beneficial effect of pacing-regulated diaphragm movement to the heart, with 10 cases of sample size and one-week follow-up after discharge.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07392749 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07392749 currently recruiting?
Yes, NCT07392749 is actively recruiting participants. Contact the research team at yaotianbao@renji.com for enrollment information.
Where is the NCT07392749 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07392749 clinical trial?
NCT07392749 is sponsored by RenJi Hospital. The trial plans to enroll 10 participants.
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