NCT06197503

Brief Summary

Single-center randomized trial in patients with pacing indication (AV block) after TAVI (transfemoral aortic valve implantation) and LVEF\> 50%, that aims to study the percentage of patients who improve at 12 months in a combined clinical endpoint.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
Nov 2023Dec 2026

Study Start

First participant enrolled

November 30, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 9, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Expected
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

December 9, 2023

Last Update Submit

March 30, 2026

Conditions

Transcatheter Aortic Valve ImplantationPhysiological PacingRight Ventricular PacingAV BlockPreserved Left Ventricular Systolic Function

Outcome Measures

Primary Outcomes (1)

  • Clinical combined endpoint: survival; and improvement > 1 point in NYHA class or > 25% increase in the distance covered in the 6-minute walking test.

    Determine the percentage of patients who improve at 12 months on a clinical combined endpoint: survival; and improvement \> 1 point in NYHA class or \> 25% increase in the distance covered in the 6-minute walking test.

    12 months

Secondary Outcomes (10)

  • Change in left ventricular ejection fraction.

    12 months.

  • Correction of echocardiographic asynchrony: septal flash expressed in mm.

    30 days; 12 months.

  • Distance covered in the 6-minute walking test.

    30 days; 12 months.

  • Change in NYHA (New York Heart Association) functional class.

    30 days; 12 months.

  • Change in degree of mitral regurgitation.

    30 days; 12 months.

  • +5 more secondary outcomes

Study Arms (2)

Conduction system pacing

EXPERIMENTAL

Lead placed in the His-Purkinje system (His or left bundle branch) in order to achieve QRS shortening and physiologic pacing. Crossover from physiological pacing to right ventricular pacing will be allowed in case of failed His bundle pacing or left bundle branch pacing.

Procedure: Conduction system pacing

Right ventricular pacing

ACTIVE COMPARATOR

Lead placed in the right ventricle (conventional pacing).

Procedure: Right ventricular pacing

Interventions

Conduction system pacingPROCEDURE

Left bundle branch pacing or His bundle branch pacing

Conduction system pacing
Right ventricular pacingPROCEDURE

Conventional pacing

Right ventricular pacing

Eligibility Criteria

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

You may qualify if:

  • Successful implantation of TAVI according to VARC-3 criteria.
  • Indication of cardiac pacing due to AV block according to ESC Guidelines.
  • LVEF\> 50%.
  • The patient must indicate their acceptance to participate in the study by signing an informed consent document.

You may not qualify if:

  • Ventricular dysfunction: LVEF \<50%.
  • Transapical TAVI.
  • Participating currently in a clinical investigation that includes an active treatment.
  • Patients with left bundle branch block but without indication of pacing (AV block).
  • Life expectancy \<12 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Atrioventricular Block

Condition Hierarchy (Ancestors)

Heart BlockArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lluís Mont, MD, PhD

    Hospital Clínic de Barcelona. IDIBAPS

    STUDY DIRECTOR

Central Study Contacts

Lluís Mont, MD, PhD

CONTACT

93 2271778 Ext. 2094lmont@clinic.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Arrhythmia Research.

Study Record Dates

First Submitted

December 9, 2023

First Posted

January 9, 2024

Study Start

November 30, 2023

Primary Completion

December 15, 2025

Study Completion (Estimated)

December 15, 2026

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)