NCT05760924: RESCUE

Left Bundle Branch Pacing on Outcomes and Ventricular Remodeling in Biventricular CRT Nonresponders

Recruiting now NA Last updated 22 November 2024

What this trial tests

NA trial testing Cardiac Resynchronization Therapy Devices with Defibrillator Function (CRT-D) or CRT-D Leads Replacement in Heart Failure in 30 participants. Currently enrolling.

Timeline

1 November 2024

Primary endpoint
1 June 2028

1 September 2028

Quick facts

Lead sponsor	Tomsk National Research Medical Center of the Russian Academy of Sciences
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 November 2024
Primary completion	1 June 2028
Estimated completion	1 September 2028
Sites	1 location across Russia

Drugs / interventions tested

• Cardiac Resynchronization Therapy Devices with Defibrillator Function (CRT-D) or CRT-D Leads Replacement
• CRT-D or CRT-D Leads Replacement with New Lead Implantation to Left Bundle Branch and Inactivation of Conventional Right and Left Ventricular Pacing
• CRT-D or CRT-D Leads Replacement with New Lead Implantation to Left Bundle Branch and Inactivation of Conventional Right Ventricular Pacing

Conditions studied

• Heart Failure — all drugs for Heart Failure →
• Left Bundle-Branch Block — all drugs for Left Bundle-Branch Block →
• Ischemic Cardiomyopathy — all drugs for Ischemic Cardiomyopathy →
• Non-ischemic Dilated Cardiomyopathy — all drugs for Non-ischemic Dilated Cardiomyopathy →

Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Who can join

Adults 18 to 80, any sex, with Heart Failure or Left Bundle-Branch Block. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Heart failure (HF) is the most common nosology encountered in clinical practice. Its incidence and prevalence increase exponentially with increasing age and it is associated with the increased mortality, more frequent hospitalization and decreased quality of life. An initial approach to the treatment of HF patients with reduced left ventricular (LV) systolic function and left bundle branch block (LBBB) was implantation of device for cardiac resynchronization therapy using biventricular pacing. This has resulted in long-term clinical benefits such as improved quality of life, increased functional capacity, reduced HF hospitalizations and overall mortality. However, conventional cardiac resynchronization therapy (CRT) is effective in only 70% of patients. And the remaining 30% of patients are non-responders to conventional CRT. Cardiac conduction system pacing is currently a promising technique for these patients. Particularly, His bundle pacing (HBP) has been developed to achieve the same results. According to other studies HBP has shown greater improvement in hemodynamic parameters comparing with conventional biventricular CRT. But, nevertheless, there are significant clinical troubles with HBP, especially high pacing threshold. In this regard, in 2017, the left bundle branch pacing (LBBP) was developed, which demonstrated clinical advantages compared to conventional biventricular CRT. Also, since 2019, left bundle branch pacing-optimized CRT (LBBPO CRT) has been used in clinical practice. These methods have become an alternative to HBP due to the stimulation of LBB outside the blocking site, a stable pacing threshold and a narrow QRS complex duration on electrocardiogram. A series of case reports and observational studies have demonstrated the efficacy and safety of LBBP and LBBPO CRT in patients with CRT indications. However, it is not enough data about impact of CRT with LBBP and combined CRT with LBBP and LV pacing on myocardial remodeling, reducing mortality and complications. According to our hypothesis, CRT with LBBP and combined CRT with LBBP and LV pacing compared with conventional biventricular pacing will significantly improve the clinical outcomes and reverse myocardial remodeling in patients who are non-responders to biventricular CRT with HF, reduced LV ejection fraction and with indications to CRT devices with defibrillator function (CRT-D) or one of the CRT-D leads replacement.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Is Conduction System Pacing a Valuable Alternative to Biventricular Pacing for Cardiac Resynchronization Therapy?
   Castagno D, Zanon F, Pastore G, De Ferrari GM, et al · · 2024 · cited 2× · PMID 38786966 · DOI 10.3390/jcdd11050144