Conventional Versus Left Bundle Branch Pacing in TAVI

Impact of Conduction System Pacing on Left Ventricular Remodeling After Transcatheter Aortic Valve Implantation

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure; Aortic Valve Stenosis; Pacemaker-Induced Cardiomyopathy; Transcatheter Aortic Valve Implantation
• Intervention / Treatment: Device: Conventional pacing; Device: Left bundle branch pacemaker

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • University Medical Centre Ljubljana
    • Sub-Investigator: David Zizek, MD, PhD
    • Contact: Klemen Steblovnik, MD, PhD; Phone Number: 0038615228529; Email: steblovnik@gmail.com
    • Principal Investigator: Klemen Steblovnik, MD, PhD
    • Sub-Investigator: Matjaz Bunc, MD, PhD
    • Sub-Investigator: Peter Marko Mihailovic, MD, PhD
    • Sub-Investigator: Simon Terseglav, MD
    • Sub-Investigator: Ana Kovac, MD, PhD
    • Sub-Investigator: Anja Zupan Meznar, MD, PhD
    • Sub-Investigator: Ljupka Dimitrovska, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional pacing	Device: Conventional pacing; Right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF < 40 %
Experimental: LBB pacing	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Left ventricular ejection fraction	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left ventricular systolic diameter		12 months
Left ventricular diastolic diameter		12 months
Global work index	Amount of myocardial work performed by the left ventricle during systole.	12 months
Global constructive work	Positive work performed in systole + negative work performed in isovolumetric relaxation	12 months
Global wasted work	Negative work performed in systole + positive work performed in isovolumetric relaxation	12 months
Global work efficiency	Percentage of constructive work over total work = Constructive work/(constructive work + wasted work)	12 months
Signs of mechanical dyssynchrony	Presence of at least one of the echocardiographic signs of mechanical dyssynchrony, such as apical rocking and septal flash.	12 months
Systolic pulmonary artery pressure (echocardiographic parameter)		12 months
NT-proBNP concentration		6 and 12 months
NYHA status		6 and 12 months
6-minute walking test		6 and 12 months
Hand grip test		6 and 12 months
The Kansas City Cardiomyopathy Questionnaire (KCCQ-12)	KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.	6 and 12 months
QRS duration		baseline, 6, and 12 months

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2023
• Primary Completion (Estimated): June 15, 2025
• Study Completion (Estimated): June 15, 2026

Study Registration Dates

• First Submitted: February 6, 2023
• First Submitted That Met QC Criteria: June 5, 2023
• First Posted (Actual): June 8, 2023

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Left bundle branch pacing; Transcatheter Aortic Valve Implantation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Cardiomyopathies
• Other Study ID Numbers: PACE TAVI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No