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NCT Number: NCT07392749

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

Location status: Recruiting

Location contact

Tianbao Dr. Yao, MD

CONTACT

[email protected]

+86 13661684786

Tianbao Yao, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DSP

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. The observation of pacing-regulated diaphragm movement for the determination of local diaphragm capture

    Time frame: Intra-procedure

  2. The diameter (or dimension) of the local venous anatomy

    Time frame: Perioperative

  3. DSP lead threshold

    Time frame: Intra-procedure

  4. Complications of the diaphragmatic synchronized pacing

    Time frame: Perioperative

Study contacts

Contact information is provided by the study sponsor or research team.

Tianbao Dr. Yao, MD

CONTACT

[email protected]

+86 13661684786

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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