Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07392749

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

Led by RenJi Hospital · Updated on 2026-02-06

10

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged �3e=18 years
  • Patients indicated for CRT or CRT-D, planned for left ventricular lead implantation
  • Patients willing to participate and provide signed informed consent
Not Eligible

You will not qualify if you...

  • CRT or CRT-D replacement
  • History of ischemic heart disease with coronary artery bypass graft (CABG)
  • History of diaphragm dysfunction
  • History of phrenic nerve injury
  • History of inferior vena cava (IVC) filter
  • History of abdominal surgery
  • Splenomegaly
  • Pulmonary disease
  • Moderate or severe liver cirrhosis
  • Severe hepatic or renal dysfunction
  • Currently pregnant or planning pregnancy during the study period
  • Participation in another study that may confound this study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Renji Hospital

Shanghai, Shanghai Municipality, China, 200127

Actively Recruiting

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Research Team

T

Tianbao Dr. Yao, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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