Feasibility Study of Diaphragm Synchronized Pacing (DSP) Via the Left Inferior Phrenic Vein (LIPV) Approach
Recruiting · NCT07392749 · Interventional (participants receive a specific treatment) · Lead sponsor: RenJi Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 can take part
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
Where it is running
1 location listed.
- Renji Hospital - Shanghai, Shanghai Municipality, China