Impact of Local Tissue Inflammation on Heart Conduction After Valve Implantation

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 Phase 2 interventional study uses 18F-FDG PET-CT to explore how local tissue inflammation relates to intramyocardial conduction pathways following percutaneous aortic valve implantation. Eligible adults with symptomatic aortic stenosis or related criteria will undergo imaging to evaluate inflammatory activity in relation to conduction changes. The study seeks to understand mechanisms that may influence post-procedure conduction and potential complications. Enrollment occurs at CHU de Brest under a single sponsor site in Brest, France. Safety and feasibility endpoints will be monitored alongside imaging findings.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Major patient (\>18 years of age);
* Patient with aortic stenosis defined by aortic valve area ≤ 1cm2 (or indexed aortic valve area ≤ 0.6 cm2/m2 body surface area), OR transvalvular peak velocity ≥ 4 m/s OR transvalvular mean gradient ≥ 40 mmHg, as assessed by transthoracic echocardiography performed in a patient at rest;
* Symptomatic patient with: dyspnea ≥ New-York Heart Association (NYHA) stage 2 OR pathological stress test with onset of symptoms on exertion, blood pressure drop, or rhythm disorder on exertion OR Asymptomatic with Left Ventricular Ejection Fraction \< 50% ;
* Patient with vascular anatomy compatible with percutaneous femoral valve implantation;
* Patient affiliated to or benefiting from a health insurance plan;
* Patient who has provided free, informed and written consent.

Exclusion Criteria:

* Patient with a pacemaker or triple chamber defibrillator prior to TAVI implantation;
* Patient with a uni or bicuspid aortic valve;
* Patient with severe left ventricular dysfunction LVEF \< 30%;
* Patient with other significant valve disease : aortic insufficiency ≥ grade 3, mitral insufficiency ≥ grade 3 or tight mitral stenosis ;
* Patient with iliofemoral vascular anatomy preventing safe passage of the valve;
* Patient with a pre-existing bioprosthesis or mechanical prosthesis at TAVI in any position;
* Inability or refusal to consent;
* Pregnant or breastfeeding woman;
* Patient under judicial protection or family habilitation;
* Patient deprived of liberty by judicial or administrative decision, under guardianship or curatorship;
* Patient with life expectancy \< 12 months.

Where it's running

• CHU de Brest
  Brest, France Recruiting

Study contacts

• Study coordinator: Romain Didier, Dr
• Email: romain.didier@chu-brest.fr
• Phone: 298347392

Similar studies

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

• Transcatheter Aortic Valve Replacement Registry for Outcomes and Quality Monitoring

  This registry collects information from hospitals about patients undergoing TAVR to see how care and outcomes compare to guidelines and nationwide data.

  Recruiting American College of Cardiology · Washington D.C., District of Columbia · NCT07908355

• Vericiguat to slow calcific aortic valve narrowing

  This trial tests whether vericiguat can slow the progression of mild-to-moderate calcific aortic valve stenosis compared with placebo.

  Recruiting Phase 2 West China Hospital · Chengdu, Sichuan · NCT07715279

• CHATEAU Registry: Real-world outcomes after TAVR

  This registry collects real-world data from adults who had TAVR between 2021 and 2025 to see how they do over time and how valve performance holds up.

  Recruiting Eunpyeong St. Mary's Hospital · Seoul · NCT07709858

• Impact of TAVR on kidney function in people with aortic valve disease

  This registry tests how trans-catheter aortic valve implantation affects kidney function and the risk of kidney injury in adults with aortic stenosis.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Roma, RM · NCT07626710

• Hydra THV Transfemoral Valve Implantation in Severe Aortic Stenosis

  This registry tests how safely and effectively the Hydra THV works when implanted through the femoral artery in adults with severe symptomatic aortic stenosis.

  Recruiting at 8 sites Fundación EPIC · Aravaca and 7 other locations · NCT07566624

• How the type of sedation affects recovery after TAVR

  This study will test whether three common sedation approaches (propofol, dexmedetomidine, or midazolam with fentanyl) change how people recover on the first day after transfemoral TAVR.

  Recruiting Phase 4 Endeavor Health · Glenview, Illinois · NCT07556523

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.