Conventional Versus Left Bundle Branch Pacing in TAVI

NCT ID: NCT05895097

Last Updated: 2023-06-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-15
• Study Completion Date: 2026-06-15

Brief Summary

This randomized study compares the effects of conventional (right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF < 40 %) versus left bundle branch pacing on left ventricular remodelling in patients with reduced left ventricular ejection fraction (< 50 %) that need permanent pacemaker implantation after transcatheter aortic valve implantation (TAVI).

Detailed Description

Bradycardic heart rhythm disturbances are a common complication of TAVI. Patients who will develop the indication for permanent pacemaker implantation after TAVI will be randomly assigned to either the experimental (left bundle branch pacing) or conventional (right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF < 40 %) group. The investigators will compare the left ventricular ejection fraction (primary outcome) 12 months after randomization. The investigators will also compare electrocardiographic (QRS duration), clinical (NYHA status, 6-minute walking test, handgrip test, Kansas City Cardiomyopathy Questionnaire) and laboratory (proBNP) parameters 6 and 12 months, and other echocardiographic (left ventricular systolic and diastolic diameter, signs of dyssynchrony, myocardial work) parameters 12 months after pacemaker implantation in both groups.

Conditions

Aortic Valve Stenosis; Heart Failure; Pacemaker-Induced Cardiomyopathy; Transcatheter Aortic Valve Implantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional pacing

Group Type: ACTIVE_COMPARATOR

Conventional pacing

Intervention Type: DEVICE

Right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF \< 40 %

LBB pacing

Group Type: EXPERIMENTAL

Left bundle branch pacemaker

Intervention Type: DEVICE

Left bundle branch pacing (LBBP) will be the pacing technique. In brief, after localizing the His bundle area the LBBP lead will be positioned approximately 1-1.5 cm distal to the His bundle position in the right ventricular septum. Before screwing the lead deep into the interventricular septum, the suitable position will be confirmed by fluoroscopic signs and adequate paced QSR morphology. Final lead position will be confirmed according to ECG parameters. Given that the pacing parameters with LBBP are typically low and stable, backup RV lead will not be mandatory.

Interventions

Left bundle branch pacemaker

Left bundle branch pacing (LBBP) will be the pacing technique. In brief, after localizing the His bundle area the LBBP lead will be positioned approximately 1-1.5 cm distal to the His bundle position in the right ventricular septum. Before screwing the lead deep into the interventricular septum, the suitable position will be confirmed by fluoroscopic signs and adequate paced QSR morphology. Final lead position will be confirmed according to ECG parameters. Given that the pacing parameters with LBBP are typically low and stable, backup RV lead will not be mandatory.

Intervention Type: DEVICE

Conventional pacing

Right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF \< 40 %

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Indication for permanent pacemaker implantation after transcatheter aortic valve implantation (during the same hospitalization)
• Left ventricular ejection fraction < 50 %.

Exclusion Criteria

• Unsuccessful TAVI procedure with life expectancy < 1 year
• Ischemic cardiomyopathy with interventricular septal fibrosis (at least echocardiographic signs of fibrosis)
• Severe kidney failure (glomerular filtration rate < 30 ml/min)
• Previous permanent pacemaker

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Centre Ljubljana

OTHER

Sponsor Role: lead

Responsible Party

Klemen Steblovnik

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Medical Centre Ljubljana

Ljubljana, , Slovenia

Countries

Slovenia

Facility Contacts

Klemen Steblovnik, MD, PhD

Role: primary

steblovnik@gmail.com

0038615228529

Other Identifiers

PACE TAVI

Identifier Type: -

Identifier Source: org_study_id