NCT07392749

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
PROCEDURE	DSP	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 Upon test completion, the catheter and lead are withdrawn, and the standard pacemaker implantation procedure is continued.

Timeline

• Start date: 2025-11-28
• Primary completion: 2026-02-28
• Completion: 2026-03-31
• First posted: 2026-02-06
• Last updated: 2026-02-06

Locations

1 site across 1 country: China