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

ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRenJi Hospital

About this trial

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

Qualifiers

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

Disqualifiers

CRT or CRT-D replacement

Ischemic heart disease with CABG history

Diaphragm dysfunction history

Phrenic nerve injury

Trial design

Treatments tested in this trial

  • DSP

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators