Heart Failure
Conditions
Keywords
CRT, CRT-D, DSP
Brief summary
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.
Interventions
PROCEDUREDSP
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 Upon test completion, the catheter and lead are withdrawn, and the standard pacemaker implantation procedure is continued.
Sponsors
RenJi Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The feasibility of local diaphragm muscle pacing | Acute, during the procedure | 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
| Measure | Time frame |
|---|---|
| The observation of pacing-regulated diaphragm movement for the determination of local diaphragm capture | Intra-procedure |
| The diameter (or dimension) of the local venous anatomy | Perioperative |
| DSP lead threshold | Intra-procedure |
| Complications of the diaphragmatic synchronized pacing | Perioperative |
Countries
China
Contacts
CONTACTTianbao Dr. Yao, MD
Outcome results
None listed