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
This trial does not accept healthy volunteersQualifiers
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
Single group
Treatments tested in this trial
DSP
Procedure/SurgeryFor 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 Upon test completion, the catheter and lead are withdrawn, and the standard pacemaker implantation procedure is continued.
Treatment groups
Trial outcomes
Primary outcomes
The feasibility of local diaphragm muscle pacing
To evaluate the success rate of diaphragm pacing and the capability of the electrode to capture the local diaphragm below the cardiac apex, providing a recommendation of venous access and route for the interventional procedure to conduct local electrical stimulation in the diaphragm.
Secondary outcomes
The observation of pacing-regulated diaphragm movement for the determination of local diaphragm capture
The diameter (or dimension) of the local venous anatomy
DSP lead threshold
Complications of the diaphragmatic synchronized pacing
Sponsors and contacts
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