Conventional Versus Left Bundle Branch Pacing in TAVI

NCT05895097 | Not Yet Recruiting

• 1 other identifier: PACE TAVI
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Transcatheter Aortic Valve Implantation; Left bundle branch pacing

Outcome Measures

Primary Outcomes (1)

• Left ventricular ejection fraction

  12 months

Secondary Outcomes (14)

• Left ventricular systolic diameter

  12 months

• Left ventricular diastolic diameter

  12 months

• Global work index

  12 months

• Global constructive work

  12 months

• Global wasted work

  12 months

Study Arms (2)

Conventional pacing

ACTIVE COMPARATOR

Device: Conventional pacing

LBB pacing

EXPERIMENTAL

Device: Left bundle branch pacemaker

Interventions

Left bundle branch pacemaker 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.

LBB pacing

Conventional pacing DEVICE

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

Conventional pacing

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Heart Failure

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

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: Principal Investigator

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: June 8, 2023
• Study Start: June 15, 2023
• Primary Completion: June 15, 2025
• Study Completion (Estimated): June 15, 2026
• Last Updated: June 8, 2023

Record last verified: 2023-06

Locations

SL (1)