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NCT Number: NCT05966675

Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post TAVI

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).

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Key information

Conditions

Atrioventricular Block, Second and Third Degree Arrhythmias, Cardiac Atrioventricular Block Bradycardia Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Heart Failure Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Silesia in Katowice

Katowice, Poland

Location status: Recruiting

Location contact

Danuta Łoboda, MD, PhD

SUB_INVESTIGATOR

Grzegorz Jarosiński, MD, PhD

SUB_INVESTIGATOR

Jolanta Biernat, MD, PhD

SUB_INVESTIGATOR

Krzysztof S. Gołba, MD PhD

CONTACT

[email protected]

Rafał Gardas, MD, PhD

SUB_INVESTIGATOR

Tomasz Soral, MD

CONTACT

[email protected]

Tomasz Soral, MD

SUB_INVESTIGATOR

About this study

A multicenter randomized controlled head-to-head trial was planned to compare the effects of permanent pacemaker implantation (PPMI) using CSP (study intervention) with currently standard therapy - RVP or BVP (control group). The study population will consist of patients hospitalized after TAVI complicated with high-degree persistent atrioventricular (AV) block or newly developed complex AV or intraventricular conduction disturbances, qualified for PPMI within 30 days after surgery, following the 2021 European Society of Cardiology (ESC) guidelines on cardiac pacing and cardiac resynchronization therapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Predicted inability to obtain cooperation from patient during observation period

Treatment and study plan

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.

Primary outcomes

  1. Heart Failure Hospitalization

    Time frame: 12 months

    Hospitalization due to heart failure as a main reason

  2. All-cause death

    Time frame: 12 months

    Death from any cause

Secondary outcomes

  1. Change in exercise capacity

    Time frame: 24 months

    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

  2. Response to Cardiac Resynchronization Therapy (CRT)

    Time frame: 24 months

    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

  3. Pacing-Induced Cardiomyopathy (PICM)

    Time frame: 24 months

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

  4. Change in global longitudinal strain (GLS)

    Time frame: 24 months

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

  5. Atrial Fibrillation (AF) episodes

    Time frame: 24 months

    Occurrence of the first episode of AF in a patient with no previous history of atrial fibrillation (AF).

  6. Atrial High Rate Episodes (AHRE) in pacemaker recordings

    Time frame: 24 months

    Occurrence or change of the burden of AHRE events in the records from the CIED.

  7. Change in the concentration of the N-terminal pro-brain natriuretic peptide (NT-proBNP)

    Time frame: 24 months

    pl/mL

  8. Change in Quality of Life

    Time frame: 24 months

    Assessed with Short Form Health Survey (SF-36): 0 to 100; low QoL to high QoL - better outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Krzysztof S. Gołba, MD PhD

CONTACT

[email protected]

+48 (32)359-88-93

Tomasz Soral, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Collaborators

  • Medical Research Agency, Poland

Registry information

Official study title

Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post Transcatheter Aortic Valve Implantation

Acronym: PACE-4-TAVI

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Aug 1, 2023
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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