CSP Versus BiVP for Heart Failure Patients with RVP Upgraded to Cardiac Resynchronization Therapy

NCT06241651 | Recruiting

• 1 other identifier: 2023-SR-811
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The present study is a prospective, multicenter, non-inferiority, randomized controlled trail. It aims to investigate whether the efficacy of conduction system pacing (CSP) is non-inferior to biventricular pacing (BiVP) in patients with heart failure and right ventricular pacing (RVP) requiring upgrading to cardiac resynchronization therapy (CRT).

Conditions

Conduction System Pacing; Biventricular Pacing; Cardiac Resynchronization Therapy; Right Ventricular Pacing; Heart Failure

Outcome Measures

Primary Outcomes (1)

• ΔLVEF

  Change in LVEF between baseline and six months after device implantation

  Baseline; 6-month follow-up

Secondary Outcomes (14)

• ΔLVEDD

  Baseline; 3-month follow-up; 6-month follow-up

• ΔLVEDV

  Baseline; 3-month follow-up; 6-month follow-up

• ΔLVESV

  Baseline; 3-month follow-up; 6-month follow-up

• Paced QRS duration

  1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up

• Echocardiographic response rate

  Baseline; 6-month follow-up

Study Arms (2)

CSP group

EXPERIMENTAL

In this group, CSP lead is attempted to be placed, including LBBP and HBP.

Device: Conduction system pacing

BiVP group

ACTIVE COMPARATOR

In this group, traditional RA lead , RV lead and LV lead are attempted to be placed.

Device: Biventricular pacing

Interventions

Conduction system pacing DEVICE

Firstly, we will attempt LBBP if the patient is allocated to the experimental group. If we can not achieve LBBP successfully, then we will turn to attempt HBP.

CSP group

Biventricular pacing DEVICE

Implantation of RA lead, RV lead and LV lead are attempted using the standard-of-care technique.

BiVP group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with symptomatic heart failure (LVEF \<50%) after right ventricular pacing for at least 3 months;
• NYHA class II-IV;
• NT-proBNP \>125pg/mL in patients with sinus rhythm, NT-proBNP \>250pg/mL in patients with atrial fibrillation;
• Right ventricular pacing percentage \>40%;
• Adult patients aged 18-80;
• With informed consent signed.

You may not qualify if:

• History of acute myocardial infarction within 3 months before enrollment;
• Frequent premature ventricular contraction (\>15%) or malignant ventricular arrhythmia which is difficult to control;
• History of valvular heart disease intervention within 3 months before enrollment;
• After mechanical tricuspid valve replacement;
• Ventricular septal hypertrophy (≥15mm during diastole);
• Complex congenital heart disease;
• History of heart transplantation;
• Enrollment in any other study;
• Pregnant or with child-bearing plan;
• A life expectancy of less than 12 months.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• The First Affiliated Hospital of Soochow University: collaborator
• The Affiliated Hospital of Xuzhou Medical University: collaborator
• The Third Affiliated Hospital of Soochow University: collaborator
• Rugao People's Hospital: collaborator
• Nanfang Hospital, Southern Medical University: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Third Affiliated Hospital, Sun Yat-Sen University: collaborator
• Shantou Central Hospital: collaborator
• Meizhou People's Hospital: collaborator
• Changzhou Second People's Hospital affiliated with Nanjing Medical University: collaborator
• Zhangjiagang First People's Hospital: collaborator
• Huizhou Third People's Hospital, Guangzhou Medical University: collaborator

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

Related Publications (8)

• Glikson M, Nielsen JC, Kronborg MB, Michowitz Y, Auricchio A, Barbash IM, Barrabes JA, Boriani G, Braunschweig F, Brignole M, Burri H, Coats AJS, Deharo JC, Delgado V, Diller GP, Israel CW, Keren A, Knops RE, Kotecha D, Leclercq C, Merkely B, Starck C, Thylen I, Tolosana JM; ESC Scientific Document Group. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J. 2021 Sep 14;42(35):3427-3520. doi: 10.1093/eurheartj/ehab364. No abstract available.

  PMID: 34455430 BACKGROUND

• Chung MK, Patton KK, Lau CP, Dal Forno ARJ, Al-Khatib SM, Arora V, Birgersdotter-Green UM, Cha YM, Chung EH, Cronin EM, Curtis AB, Cygankiewicz I, Dandamudi G, Dubin AM, Ensch DP, Glotzer TV, Gold MR, Goldberger ZD, Gopinathannair R, Gorodeski EZ, Gutierrez A, Guzman JC, Huang W, Imrey PB, Indik JH, Karim S, Karpawich PP, Khaykin Y, Kiehl EL, Kron J, Kutyifa V, Link MS, Marine JE, Mullens W, Park SJ, Parkash R, Patete MF, Pathak RK, Perona CA, Rickard J, Schoenfeld MH, Seow SC, Shen WK, Shoda M, Singh JP, Slotwiner DJ, Sridhar ARM, Srivatsa UN, Stecker EC, Tanawuttiwat T, Tang WHW, Tapias CA, Tracy CM, Upadhyay GA, Varma N, Vernooy K, Vijayaraman P, Worsnick SA, Zareba W, Zeitler EP. 2023 HRS/APHRS/LAHRS guideline on cardiac physiologic pacing for the avoidance and mitigation of heart failure. Heart Rhythm. 2023 Sep;20(9):e17-e91. doi: 10.1016/j.hrthm.2023.03.1538. Epub 2023 May 20.

  PMID: 37283271 BACKGROUND

• Tops LF, Schalij MJ, Bax JJ. The effects of right ventricular apical pacing on ventricular function and dyssynchrony implications for therapy. J Am Coll Cardiol. 2009 Aug 25;54(9):764-76. doi: 10.1016/j.jacc.2009.06.006.

  PMID: 19695453 BACKGROUND

• Kaye GC, Linker NJ, Marwick TH, Pollock L, Graham L, Pouliot E, Poloniecki J, Gammage M; Protect-Pace trial investigators. Effect of right ventricular pacing lead site on left ventricular function in patients with high-grade atrioventricular block: results of the Protect-Pace study. Eur Heart J. 2015 Apr 7;36(14):856-62. doi: 10.1093/eurheartj/ehu304. Epub 2014 Sep 4.

  PMID: 25189602 BACKGROUND

• Khurshid S, Obeng-Gyimah E, Supple GE, Schaller R, Lin D, Owens AT, Epstein AE, Dixit S, Marchlinski FE, Frankel DS. Reversal of Pacing-Induced Cardiomyopathy Following Cardiac Resynchronization Therapy. JACC Clin Electrophysiol. 2018 Feb;4(2):168-177. doi: 10.1016/j.jacep.2017.10.002. Epub 2017 Nov 15.

  PMID: 29749933 BACKGROUND

• Shan P, Su L, Zhou X, Wu S, Xu L, Xiao F, Zhou X, Ellenbogen KA, Huang W. Beneficial effects of upgrading to His bundle pacing in chronically paced patients with left ventricular ejection fraction <50. Heart Rhythm. 2018 Mar;15(3):405-412. doi: 10.1016/j.hrthm.2017.10.031. Epub 2017 Nov 16.

  PMID: 29081396 BACKGROUND

• Qian Z, Wang Y, Hou X, Qiu Y, Wu H, Zhou W, Zou J. Efficacy of upgrading to left bundle branch pacing in patients with heart failure after right ventricular pacing. Pacing Clin Electrophysiol. 2021 Mar;44(3):472-480. doi: 10.1111/pace.14147. Epub 2021 Jan 31.

  PMID: 33372293 BACKGROUND

• Merkely B, Hatala R, Wranicz JK, Duray G, Foldesi C, Som Z, Nemeth M, Goscinska-Bis K, Geller L, Zima E, Osztheimer I, Molnar L, Karady J, Hindricks G, Goldenberg I, Klein H, Szigeti M, Solomon SD, Kutyifa V, Kovacs A, Kosztin A. Upgrade of right ventricular pacing to cardiac resynchronization therapy in heart failure: a randomized trial. Eur Heart J. 2023 Oct 21;44(40):4259-4269. doi: 10.1093/eurheartj/ehad591.

  PMID: 37632437 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Central Study Contacts

Jiangang Zou

CONTACT

86-13605191407; jgzou@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Internal Medicine

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: February 5, 2024
• Study Start: January 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)