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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 Criteria: * 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

Treatments Being Tested

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.

Locations (1)

Renji Hospital
Shanghai, Shanghai Municipality, China