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Recruiting NCT07392749

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

No phase Interventional Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DSP.
Who it may be relevant to
Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • 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 impa

Primary outcome measures

  • The feasibility of local diaphragm muscle pacing [Time frame: Acute, during the procedure]
Secondary outcome measures (4)
  • The observation of pacing-regulated diaphragm movement for the determination of local diaphragm capture [Time frame: Intra-procedure]
  • The diameter (or dimension) of the local venous anatomy [Time frame: Perioperative]
  • DSP lead threshold [Time frame: Intra-procedure]
  • Complications of the diaphragmatic synchronized pacing [Time frame: Perioperative]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Renji Hospital — Shanghai

Publications

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT07392749 · DSP-LIPV study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗