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

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of pacemaker technology — conventional right-ventricular pacing versus physiologic cardiac pacing (which tries to mimic the heart's natural electrical pathway) — in patients who develop heart conduction problems after a transcatheter aortic valve implantation (TAVI), a minimally invasive procedure to replace a diseased heart valve. **You may be eligible if...** - You recently had a TAVI procedure (within the past 30 days) - You developed a heart conduction problem (such as a heart block) after TAVI that requires a permanent pacemaker - You are at least 18 years old - You have given written informed consent **You may NOT be eligible if...** - You had a pacemaker implanted before your TAVI procedure - Your conduction problem developed more than 30 days after TAVI - You are unable to give informed consent - Certain anatomical or technical factors make one type of pacing lead placement impossible Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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