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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • DSP

    Procedure/Surgery

    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 Upon test completion, the catheter and lead are withdrawn, and the standard pacemaker implantation procedure is continued.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: DSP LIPV groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Acute, during the procedure

Secondary outcomes

1

The observation of pacing-regulated diaphragm movement for the determination of local diaphragm capture

Time frame
Intra-procedure
2

The diameter (or dimension) of the local venous anatomy

Time frame
Perioperative
3

DSP lead threshold

Time frame
Intra-procedure
4

Complications of the diaphragmatic synchronized pacing

Time frame
Perioperative

Other outcomes

Sponsors and contacts

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