RecruitingNot ApplicableNCT05966675

Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post TAVI

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


Sponsor

Medical University of Silesia

Enrollment

500 participants

Start Date

Feb 27, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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

Interventions

DEVICEconduction system pacing

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

DEVICEright ventricular or biventricular pacing

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


Locations(1)

Medical University of Silesia in Katowice

Katowice, Poland

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NCT05966675


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