Heart FailureNCT05985408
LVSP Based CRT vs. RVAP Based CRT
A study testing left ventricular septal pacing and right ventricular apical pacing in people with Heart Failure and Cardiac Resynchronization Therapy, run by Fu Wai Hospital, Beijing, China at 1 site in China.
Trial summary
To find out whether left ventricular septal pacing (LVSP)-based cardiac resynchronization therapy (CRT) is superior to right ventricular apical pacing (RVAP)-based CRT in patients with failed left bundle branch pacing at the beginning of chronic heart failure. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Failure, Cardiac Resynchronization Therapy, Left Ventricular Septal Pacing
- What is being tested?
- left ventricular septal pacing and right ventricular apical pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Chronic heart failure, LVEF ≤35% after at least 3 months of guideline-optimized drug therapy, NYHA class II-IV with complete left bundle branch block (QRSd≥130 ms), OR Atrioventricular block with LVEF ≤ 50% with the indication of cardiac pacing; 3. Age between 18 and 90 years old; 4. The expected survival period is greater than 12 months; 5. Signed the informed consent form for the study.
Who cannot join
- Previous mechanical tricuspid valve replacement.
- Previous pacemaker or other devices implanted and for device replacement or upgrading for this time.
- Patients have a history of unstable angina, acute myocardial infarction, CABG, and PCI surgery within three months.
- Persistent atrial fibrillation without AV block, the proportion of biventricular pacing is not expected to less than 95%.
- Patients participated in any of the other studies at the same time, which may confound the results of this study.
- Pregnancy, planning to become pregnant.
- 8. Patients with a history of heart transplantation.
Trial locations and contacts
1 site in 1 country.
China1 site
Fuwai hospital
Beijing, Beijing Municipality, 100037
Xiaofei Li, Doctor, 17801013995, lixiaofei0103@163.com
About this study
Official title: Left Ventricular Septal Pacing Based Rescue CRT Versus Right Ventricular Apical Pacing Based CRT for Chronic Heart Failure: a Randomized Controlled Trial
To find out whether left ventricular septal pacing (LVSP)-based cardiac resynchronization therapy (CRT) is superior to right ventricular apical pacing (RVAP)-based CRT in patients with failed left bundle branch pacing at the beginning of chronic heart failure.
- Conditions
- Heart Failure, Cardiac Resynchronization Therapy, Left Ventricular Septal Pacing, Right Ventricular Septal Pacing
- Being tested
- left ventricular septal pacing, right ventricular apical pacing
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
left ventricular septal pacingDevice
For left bundle branch pacing (LBBP) failure cases, use left ventricular septal pacing instead of LBBP; others were same as traditional CRT.
right ventricular apical pacingDevice
For left bundle branch pacing (LBBP) failure cases, use right ventricular apical pacing instead of LBBP; others were same as traditional CRT.
| Study group | Role | What they receive |
|---|---|---|
| LVSP-CRT | Experimental | Patients received LVSP based CRT implantation; LVSP, left ventricular septal pacing; CRT, cardiac resynchronization therapy. Receives: Device: left ventricular septal pacing |
| RVAP-CRT | Active comparator | Patients received RVAP based CRT implantation; RVAP, right ventricular apical pacing; CRT, cardiac resynchronization therapy. Receives: Device: right ventricular apical pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
left ventricular ejection fraction (LVEF)
LVEF evaluated by echocardiography，Bi-plane Simpson's method
Measured: 6 months
left ventricular ejection fraction (LVEF)
LVEF evaluated by echocardiography，Bi-plane Simpson's method
Measured: 12 months
left ventricular end-systolic volume (LVESV)
LVESV evaluated by echocardiography
Measured: 6 months
left ventricular end-systolic volume (LVESV)
LVESV evaluated by echocardiography
Measured: 12 months
Secondary outcomes (13)
paced QRSd duration.
QRS duration measurement after the procedure
Measured: 6 months
paced QRSd duration.
QRS duration measurement after the procedure
Measured: 12 months
NT-proBNP
Serum NT-proBNP level
Measured: 6 months
NT-proBNP
Serum NT-proBNP level
Measured: 12 months
6-minute hall walk distance
6-minute hall walk distance
Measured: 6 months
6-minute hall walk distance
6-minute hall walk distance
Measured: 12 months
Heart failure rehospitalization
Rehospitalization due to the exacerbation of heart failure
Measured: 6 months
Heart failure rehospitalization
Rehospitalization due to the exacerbation of heart failure
Measured: 12 months
Rehospitalization for cardiovascular adverse events
Rehospitalization for cardiovascular adverse events
Measured: 12 months
Malignant ventricular arrhythmias
ICD therapy for ventricular tachycardia or ventricular fibrillation
Measured: 6 months
Malignant ventricular arrhythmias
ICD therapy for ventricular tachycardia or ventricular fibrillation
Measured: 12 months
All cause death
All cause death events
Measured: 6 months
All cause death
All cause death events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Wai Hospital, Beijing, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Xiaofei, Fu Wai Hospital, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985408
- Sponsor's protocol ID
- 2023-0801
- Status last verified
- Aug 2023
- First submitted
- 3 Aug 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Ferrick AM, Raj SR, Deneke T, Kojodjojo P, Lopez-Cabanillas N, Abe H, Boveda S, Chew DS, Choi JI, Dagres N, Dalal AS, Dechert BE, Frazier-Mills CG, Gilbert O, Han JK, Hewit S, Kneeland C, DeEllen Mirza S, Mittal S, Ricci RP, Runte M, Sinclair S, Alkmim-Teixeira R, Vandenberk B, Varma N. 2023 HRS/EHRA/APHRS/LAHRS expert consensus statement on practical management of the remote device clinic. Heart Rhythm. 2023 Sep;20(9):e92-e144. doi: 10.1016/j.hrthm.2023.03.1525. Epub 2023 May 19.
PubMed 37211145Zhang J, Zhang Y, Sun Y, Chen M, Wang Z, Ma C. Success rates, challenges and troubleshooting of left bundle branch area pacing as a cardiac resynchronization therapy for treating patients with heart failure. Front Cardiovasc Med. 2023 Jan 10;9:1062372. doi: 10.3389/fcvm.2022.1062372. eCollection 2022.
PubMed 36704478Curila K, Jurak P, Jastrzebski M, Prinzen F, Waldauf P, Halamek J, Vernooy K, Smisek R, Karch J, Plesinger F, Moskal P, Susankova M, Znojilova L, Heckman L, Viscor I, Vondra V, Leinveber P, Osmancik P. Left bundle branch pacing compared to left ventricular septal myocardial pacing increases interventricular dyssynchrony but accelerates left ventricular lateral wall depolarization. Heart Rhythm. 2021 Aug;18(8):1281-1289. doi: 10.1016/j.hrthm.2021.04.025. Epub 2021 Apr 28.
PubMed 33930549
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Ventricular Septal Pacing Based Rescue CRT Versus Right Ventricular Apical Pacing Based CRT for Chronic Heart Failure: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05985408
- Acronym / sponsor ID
- 2023-0801
- Conditions
- Heart Failure, Cardiac Resynchronization Therapy, Left Ventricular Septal Pacing, Right Ventricular Septal Pacing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fu Wai Hospital, Beijing, ChinaUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 14 Aug 2023 (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.
To find out whether left ventricular septal pacing (LVSP)-based cardiac resynchronization therapy (CRT) is superior to right ventricular apical pacing (RVAP)-based CRT in patients with failed left bundle branch pacing at the beginning of chronic heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LVSP-CRT | Experimental | Device: left ventricular septal pacingPatients received LVSP based CRT implantation; LVSP, left ventricular septal pacing; CRT, cardiac resynchronization therapy. |
| RVAP-CRT | Active comparator | Device: right ventricular apical pacingPatients received RVAP based CRT implantation; RVAP, right ventricular apical pacing; CRT, cardiac resynchronization therapy. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Chronic heart failure, LVEF ≤35% after at least 3 months of guideline-optimized drug therapy, NYHA class II-IV with complete left bundle branch block (QRSd≥130 ms), OR Atrioventricular block with LVEF ≤ 50% with the indication of cardiac pacing; 3. Age between 18 and 90 years old; 4. The expected survival period is greater than 12 months; 5. Signed the informed consent form for the study.
Key exclusion criteria (7 listed)
- Previous mechanical tricuspid valve replacement.
- Previous pacemaker or other devices implanted and for device replacement or upgrading for this time.
- Patients have a history of unstable angina, acute myocardial infarction, CABG, and PCI surgery within three months.
- Persistent atrial fibrillation without AV block, the proportion of biventricular pacing is not expected to less than 95%.
- Patients participated in any of the other studies at the same time, which may confound the results of this study.
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 |
|---|---|---|
| left ventricular septal pacingFor left bundle branch pacing (LBBP) failure cases, use left ventricular septal pacing instead of LBBP; others were same as traditional CRT. | Device | LVSP-CRT |
| right ventricular apical pacingFor left bundle branch pacing (LBBP) failure cases, use right ventricular apical pacing instead of LBBP; others were same as traditional CRT. | Device | RVAP-CRT |
Primary outcome
left ventricular ejection fraction (LVEF)
Time frame: 6 months
LVEF evaluated by echocardiography，Bi-plane Simpson's method
left ventricular ejection fraction (LVEF)
Time frame: 12 months
LVEF evaluated by echocardiography，Bi-plane Simpson's method
left ventricular end-systolic volume (LVESV)
Time frame: 6 months
LVESV evaluated by echocardiography
left ventricular end-systolic volume (LVESV)
Time frame: 12 months
LVESV evaluated by echocardiography
13 secondary outcomes
paced QRSd duration.
Time frame: 6 months
paced QRSd duration.
Time frame: 12 months
NT-proBNP
Time frame: 6 months
NT-proBNP
Time frame: 12 months
6-minute hall walk distance
Time frame: 6 months
6-minute hall walk distance
Time frame: 12 months
Heart failure rehospitalization
Time frame: 6 months
Heart failure rehospitalization
Time frame: 12 months
Rehospitalization for cardiovascular adverse events
Time frame: 12 months
Malignant ventricular arrhythmias
Time frame: 6 months
Malignant ventricular arrhythmias
Time frame: 12 months
All cause death
Time frame: 6 months
All cause death
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Results publication: PubMed 37211145Ferrick AM, Raj SR, Deneke T, Kojodjojo P, Lopez-Cabanillas N, Abe H, Boveda S, Chew DS, Choi JI, Dagres N, Dalal AS, Dechert BE, Frazier-Mills CG, Gilbert O, Han JK, Hewit S, Kneeland C, DeEllen Mirza S, Mittal S, Ricci RP, Runte M, Sinclair S, Alkmim-Teixeira R, Vandenberk B, Varma N. 2023 HRS/EHRA/APHRS/LAHRS expert consensus statement on practical management of the remote device clinic. Heart Rhythm. 2023 Sep;20(9):e92-e144. doi: 10.1016/j.hrthm.2023.03.1525. Epub 2023 May 19.
- Results publication: PubMed 36704478Zhang J, Zhang Y, Sun Y, Chen M, Wang Z, Ma C. Success rates, challenges and troubleshooting of left bundle branch area pacing as a cardiac resynchronization therapy for treating patients with heart failure. Front Cardiovasc Med. 2023 Jan 10;9:1062372. doi: 10.3389/fcvm.2022.1062372. eCollection 2022.
- Results publication: PubMed 33930549Curila K, Jurak P, Jastrzebski M, Prinzen F, Waldauf P, Halamek J, Vernooy K, Smisek R, Karch J, Plesinger F, Moskal P, Susankova M, Znojilova L, Heckman L, Viscor I, Vondra V, Leinveber P, Osmancik P. Left bundle branch pacing compared to left ventricular septal myocardial pacing increases interventricular dyssynchrony but accelerates left ventricular lateral wall depolarization. Heart Rhythm. 2021 Aug;18(8):1281-1289. doi: 10.1016/j.hrthm.2021.04.025. Epub 2021 Apr 28.
- Individual participant dataSharing planned: 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing left ventricular septal pacing and right ventricular apical pacing in people with Heart Failure and Cardiac Resynchronization Therapy, run by Fu Wai Hospital, Beijing, China 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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 14 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
left ventricular ejection fraction (LVEF) (time frame: 6 months). The study lists 4 primary outcomes in all. 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 NCT05985408, which also lists 3 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 14 Aug 2023.