Heart FailureNCT07392749
Feasibility Study of Diaphragm Synchronized Pacing (DSP) Via the Left Inferior Phrenic Vein (LIPV) Approach
A study testing DSP in people with Heart Failure, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- DSP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 28 Nov 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- CRT or CRT-D replacement
- Ischemic heart disease with CABG history
- Diaphragm dysfunction history
- Phrenic nerve injury
- IVC filter history
- Abdominal surgery history
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai, Shanghai Municipality, 200127
Tianbao Dr. Yao, MD, +86 13661684786, yaotianbao@renji.com
Tianbao Yao, MD
About this study
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
- Being tested
- DSP
- Keywords
- CRT, CRT-D, DSP
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSPProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| DSP LIPV group | Experimental | Not described Receives: Procedure: DSP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Acute, during the procedure
Secondary outcomes (4)
The observation of pacing-regulated diaphragm movement for the determination of local diaphragm capture
Measured: Intra-procedure
The diameter (or dimension) of the local venous anatomy
Measured: Perioperative
DSP lead threshold
Measured: Intra-procedure
Complications of the diaphragmatic synchronized pacing
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start28 Nov 2025
- Primary completion28 Feb 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tianbao Yao, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392749
- Sponsor's protocol ID
- DSP-LIPV study
- Status last verified
- Jan 2026
- First submitted
- 8 Dec 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
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.
PubMed 40557395McIntosh 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.
PubMed 31660505Fujii 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.
PubMed 36088466Beeler 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.
PubMed 24464736Roos 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.
PubMed 19168496Sieniewicz 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.
PubMed 30143910Jorbendaze 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.
PubMed 35619238
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Diaphragm Synchronized Pacing (DSP) Via the Left Inferior Phrenic Vein (LIPV) Approach
- ClinicalTrials.gov ID
- NCT07392749
- Acronym / sponsor ID
- DSP-LIPV study
- Conditions
- Heart Failure
- Keywords
- CRT, CRT-D, DSP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 28 Nov 2025 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DSP LIPV group | Experimental | Procedure: DSP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- CRT or CRT-D replacement
- Ischemic heart disease with CABG history
- Diaphragm dysfunction history
- Phrenic nerve injury
- IVC filter history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DSPFor 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. | Procedure or surgery | DSP LIPV group |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Background: PubMed 40557395Dando 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.
- Background: PubMed 31660505McIntosh 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.
- Background: PubMed 36088466Fujii 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.
- Background: PubMed 24464736Beeler 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.
- Background: PubMed 19168496Roos 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.
- Background: PubMed 30143910Sieniewicz 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.
- Results publication: PubMed 35619238Jorbendaze 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.
- Individual participant dataSharing planned: Undecided. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DSP in people with Heart Failure, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tianbao Dr. Yao, MD (+86 13661684786, yaotianbao@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The feasibility of local diaphragm muscle pacing (time frame: Acute, during the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07392749, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.