RecruitingNot ApplicableNCT07392749

Feasibility Study of Diaphragm Synchronized Pacing (DSP) Via the Left Inferior Phrenic Vein (LIPV) Approach

Sponsor

RenJi Hospital

Enrollment

10 participants

Start Date

Nov 28, 2025

Study Type

INTERVENTIONAL

Conditions

Heart Failure

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

Min Age: 18 Years

Inclusion Criteria3

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 Criteria12

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

Interventions

PROCEDUREDSP

For patients with indications for CRT or CRT-D, a pacing electrode delivery sheath is inserted via the subclavian approach following the placement of the atrial electrode as part of the conventional pacemaker implantation procedure. Angiography is performed at the level of the LIPV to visualize its course. Subsequently, a quadripolar ventricular lead is advanced through the sheath into the LIPV to conduct diaphragmatic pacing testing, observing the diaphragmatic pacing effectiveness and its impact on cardiac activity. Upon test completion, the catheter and lead are withdrawn, and the standard pacemaker implantation procedure is continued.