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Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post TAVI

ConditionAtrioventricular Block, Second and Third Degree
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Silesia

About this trial

The study aims to compare permanent Conduction System Pacing (CSP) with the standard therapy - Right Ventricular Pacing (RVP) or Biventricular Pacing (BVP) - in preventing the development and progression of symptomatic Chronic Heart Failure (CHF) and improving survival in patients after Transcatheter Aortic Valve Implantation (TAVI).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

transcatheter aortic valve implantation (TAVI) in up to 30 days before qualification to pacemaker implantation

Fulfilled criteria for permanent pacemaker implantation according do 2021 ESC guidelines

Written informed consent

Age of at least 18 years

Disqualifiers

Permanent pacemaker implantation before TAVI procedure

The occurrence of conduction disturbances more than 30 days after TAVI procedure

No written informed consent

Inability to obtain informed consent from participant

Trial design

Design model

Parallel

Treatments tested in this trial

  • conduction system pacing

    Device

    Implantation of cardiac implantable electronic device (CIED) with conduction system pacing (left bundle branch area pacing or his bundle pacing).

  • right ventricular or biventricular pacing

    Device

    Implantation of cardiac implantable electronic device with right ventricular or biventricular pacing according to left ventricular ejection fraction and current ESC guidelines.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Conduction System PacingExperimental treatment 1 intervention
Group B: Standard Pacing MethodActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Heart Failure Hospitalization

Hospitalization due to heart failure as a main reason

Time frame
12 months
2

All-cause death

Death from any cause

Time frame
12 months

Secondary outcomes

1

Change in exercise capacity

Improvement or deterioration in exercise capacity assessed as a change of ≥1 New York Heart Association (NYHA) functional class or a change in 6-Minute Walk Test (6MWT) distance by 55m or more

Time frame
24 months
2

Response to Cardiac Resynchronization Therapy (CRT)

Meeting the echocardiographic criteria of response to CRT defined as a decrease in Left Ventricular End Systolic Volume by ≥15% or an increase in Left Ventricular Ejection Fraction by ≥5% from the baseline values

Time frame
24 months
3

Pacing-Induced Cardiomyopathy (PICM)

Pacing-related CHF meeting the echocardiographic criteria of PICM defined as a decrease in LVEF by \>=10% to the absolute value of \<50%

Time frame
24 months
4

Change in global longitudinal strain (GLS)

An increase in GLS value of 20 absolute percentage points from baseline or an increase above -16%.

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of Silesia

Lead sponsor

Medical Research Agency, Poland

Collaborator

Source ClinicalTrials.gov
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