NCT05024279

Brief Summary

Prospective, randomized, single center clinical trial to compare the outcome of left bundle branch area pacing versus right ventricular apical pacing in patients with higher degree atrio-ventricular block and a normal left ventricular function after transcatheter aortic valve replacement.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 6, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 27, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

1.7 years

First QC Date

August 9, 2021

Last Update Submit

January 30, 2023

Conditions

Aortic Valve StenosisAV BlockPacing-Induced Cardiomyopathy

Keywords

left bundle branch area pacingav blockright ventricular pacingaortic valve stenosisTAVRECG

Outcome Measures

Primary Outcomes (1)

  • QRS duration

    QRS duration on 12-lead ECG, defined as earliest Q to latest S across all leads

    3 months

Secondary Outcomes (38)

  • QRS duration

    12 months

  • QRS duration

    24 months

  • Death of any cause

    3 months

  • Death of any cause

    12 months

  • Death of any cause

    24 months

  • +33 more secondary outcomes

Other Outcomes (7)

  • Pacemaker-associated complications

    3 months

  • Pacemaker-associated complications

    12 months

  • Pacemaker-associated complications

    24 months

  • +4 more other outcomes

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Patients are randomized to receive left bundle branch are pacing due to higher degree AV block

Device: Left bundle branch area pacing

Control Arm

ACTIVE COMPARATOR

Patients are randomized to receive standard right ventricular pacing due to higher degree AV block.

Device: Right ventricular pacing

Interventions

Left bundle branch area pacingDEVICE

Left bundle branch area pacing will be applied as established in the literature using commercially available equipment. In case of unsuccessful application of left bundle branch area pacing, cross-over to right ventricular pacing is allowed.

Intervention Arm
Right ventricular pacingDEVICE

Right ventricular pacing as the standard, established form of pacing will be applied in the control group. No cross-over to the intervention arm is anticipated.

Control Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Successful TAVR implantation for classical (high flow high gradient), symptomatic aortic valve stenosis
  • LVEF ≥50%
  • Guideline-based indication for pacing due to AV block III°, AV block II°, or symptomatic bradycardic atrial fibrillation with an expecteed ventricular pacing burden \>20%
  • Signed informeed conseent to study participation

You may not qualify if:

  • LVEF \<50%
  • Expected pacing burden \<20%
  • Pre-existing implanted cardiac device
  • Participation in a concurring interventional trial
  • age \<18 years
  • Current preegnancy
  • life expectancy \<6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LMU Klinikum

Munich, Bavaria, 81377, Germany

Location

MeSH Terms

Conditions

Aortic Valve StenosisAtrioventricular Block

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow ObstructionHeart BlockArrhythmias, CardiacCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Moritz F Sinner, MD, MPH

    LMU Klinikum, Dept. of Cardiology

    PRINCIPAL INVESTIGATOR

  • Stephanie Fichtner, MD

    LMU Klinikum, Dept. of Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1:1 randomization
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 9, 2021

First Posted

August 27, 2021

Study Start

August 6, 2021

Primary Completion

April 1, 2023

Study Completion

April 1, 2025

Last Updated

January 31, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)