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

January 29, 2026 updated by: Tianbao Yao, RenJi Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200127
        • Recruiting
        • RenJi Hospital
        • Contact:
        • Principal Investigator:
          • Tianbao Yao, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DSP LIPV group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The feasibility of local diaphragm muscle pacing
Time Frame: 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.
Acute, during the procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
The observation of pacing-regulated diaphragm movement for the determination of local diaphragm capture
Time Frame: Intra-procedure
Intra-procedure
The diameter (or dimension) of the local venous anatomy
Time Frame: Perioperative
Perioperative
DSP lead threshold
Time Frame: Intra-procedure
Intra-procedure
Complications of the diaphragmatic synchronized pacing
Time Frame: Perioperative
Perioperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2025

Primary Completion (Estimated)

February 28, 2026

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

December 8, 2025

First Submitted That Met QC Criteria

January 29, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSP-LIPV study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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