Comparing two pacing methods after heart valve surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the effects of physiological pacing versus right ventricular pacing in patients who have undergone transcatheter aortic valve implantation (TAVI) and have preserved left ventricular function. It aims to determine which pacing strategy leads to better clinical outcomes and echocardiographic parameters over a 12-month period. The study will include 24 patients with AV block and will assess various health metrics, including survival rates, quality of life, and heart function. Participants will be randomly assigned to one of the two pacing methods to evaluate their effectiveness.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where it's running

• Hospital Clínic de Barcelona
  Barcelona, Spain Recruiting

Study contacts

• Study coordinator: Lluís Mont, MD, PhD
• Email: lmont@clinic.cat
• Phone: 93 2271778 Ext. 2094

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• SPIKE FLOW endocardial pacing lead safety and performance study

  This study tests whether the SPIKE FLOW temporary endocardial pacing lead is safe and effective in adults needing temporary pacing during heart-related conditions.

  Recruiting at 2 sites FIAB SpA · Acquaviva delle Fonti, Bari and 2 other locations · NCT07820072

• Micra AV2 leadless pacemaker to improve AV synchrony in AV block

  This study will test whether the Micra AV2 leadless pacemaker improves AV synchrony and is safe for adults with high‑degree AV block who have normal sinus rhythm.

  Recruiting Universitaire Ziekenhuizen KU Leuven · Leuven, Flemish Brabant · NCT07356505

• Comparing two pacemaker pacing methods for AV block

  This trial tests whether conduction system (left bundle branch area) pacing or standard right ventricular pacing works better for people with atrioventricular block who need a permanent pacemaker.

  Recruiting at 2 sites University of Tartu · Tallinn, Harju and 1 other locations · NCT07276490

• Left bundle branch area pacing with Tendril STS or UltiPace leads

  This study will try left bundle branch area pacing with the Tendril STS or UltiPace lead in adults who need pacemaker leads for bradycardia or related heart conditions to see if pacing and sensing are safe and work through six months after implant.

  Recruiting at 13 sites Abbott Medical Devices · Rio de Janeiro, Rio de Janeiro and 14 other locations · NCT07217392

• LivIQ leadless pacemaker system for ventricular pacing

  This trial will test the LivIQ leadless pacemaker in adults who need ventricular pacing (VVI or VDD) to see if it is safe and maintains appropriate heart rhythm and AV timing.

  Recruiting at 41 sites Biotronik, Inc. · Burlingame, California and 42 other locations · NCT07118358

• Comparing two pain management techniques for patients undergoing heart valve replacement

  This study is testing two different pain relief methods for patients having heart valve replacement surgery to see which one helps them feel better after the procedure.

  Recruiting Medipol University · Istanbul · NCT06773780

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.