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

NCT07392749 | Recruiting

• 1 other identifier: DSP-LIPV study
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

CRT; CRT-D; DSP

Outcome Measures

Primary Outcomes (1)

• The feasibility of local diaphragm muscle pacing

  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 Outcomes (4)

• 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

Study Arms (1)

DSP LIPV group

EXPERIMENTAL

Procedure: DSP

Interventions

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 Upon test completion, the catheter and lead are withdrawn, and the standard pacemaker implantation procedure is continued.

DSP LIPV group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Related Publications (7)

• Dando L, Howick V JF, Yoo J, Kella DK, McLeod CJ, van Niekerk CJ. Left inferior phrenic vein ICD lead implantation. HeartRhythm Case Rep. 2025 Mar 18;11(6):534-538. doi: 10.1016/j.hrcr.2025.03.010. eCollection 2025 Jun. No abstract available.

  PMID: 40557395 BACKGROUND

• McIntosh RA, Ansari MI, Moon J, Khan HR. Delivery of cardiac resynchronization therapy via the left inferior phrenic vein: a case report. Eur Heart J Case Rep. 2019 Sep 16;3(3):ytz144. doi: 10.1093/ehjcr/ytz144. eCollection 2019 Sep.

  PMID: 31660505 BACKGROUND

• Fujii Y, Koizumi J, Sekiguchi Y, Ono S, Sekiguchi T, Hara T, Hashimoto J. Morphometric assessment of the left inferior phrenic vein in patients with portal hypertension. Sci Rep. 2022 Sep 10;12(1):15275. doi: 10.1038/s41598-022-19610-w.

  PMID: 36088466 BACKGROUND

• Beeler R, Schoenenberger AW, Bauer P, Kobza R, Bergner M, Mueller X, Schlaepfer R, Zuber M, Erne S, Erne P. Improvement of cardiac function with device-based diaphragmatic stimulation in chronic heart failure patients: the randomized, open-label, crossover Epiphrenic II Pilot Trial. Eur J Heart Fail. 2014 Mar;16(3):342-9. doi: 10.1002/ejhf.20. Epub 2013 Dec 6.

  PMID: 24464736 BACKGROUND

• Roos M, Kobza R, Jamshidi P, Bauer P, Resink T, Schlaepfer R, Stulz P, Zuber M, Erne P. Improved cardiac performance through pacing-induced diaphragmatic stimulation: a novel electrophysiological approach in heart failure management? Europace. 2009 Feb;11(2):191-9. doi: 10.1093/europace/eun377.

  PMID: 19168496 BACKGROUND

• Sieniewicz BJ, Gould J, Porter B, Sidhu BS, Teall T, Webb J, Carr-White G, Rinaldi CA. Understanding non-response to cardiac resynchronisation therapy: common problems and potential solutions. Heart Fail Rev. 2019 Jan;24(1):41-54. doi: 10.1007/s10741-018-9734-8.

  PMID: 30143910 BACKGROUND

• Jorbendaze A, Young R, Shaburishvili T, Demyanchuk V, Buriak R, Todurov B, Rudenko K, Zuber M, Stampfli SF, Tanner FC, Erne P, Mirro M, Fudim M, Goldberg LR, Cleland JGF. Synchronized diaphragmatic stimulation for heart failure using the VisONE system: a first-in-patient study. ESC Heart Fail. 2022 Aug;9(4):2207-2214. doi: 10.1002/ehf2.13984. Epub 2022 May 26.

  PMID: 35619238 RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Tianbao Dr. Yao, MD

CONTACT

+86 13661684786; yaotianbao@renji.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: February 6, 2026
• Study Start: November 28, 2025
• Primary Completion: February 28, 2026
• Study Completion: March 31, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-01

Locations

CN (1)