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Taking people in FrancePhase 2

PET scans of heart inflammation after percutaneous valve replacement for aortic valve stenosis

Uses PET scans to look at heart inflammation in people with aortic valve stenosis.

Key facts

Who runs it
University Hospital, Brest
Where
Brest, FranceSee the site
Trial code
Registry title
Impact of Local Tissue Inflammation on Intramyocardial Conduction Pathways Post Percutaneous Valve : Evaluation by Positron Emission Tomography on Exploratory Cohort
Status
Recruiting
Phase
Phase 2
People taking part
100 people, planned
Started
23 Nov 2022
Expected to end
23 Nov 2028
Type of study
Interventional
Treatments tested
  • 18F-FDG PET-CT
Record updated
9 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with narrowing of the aortic heart valve (aortic stenosis) who will get a new valve through a blood vessel in the groin (TAVI). All will have an 18F-FDG PET-CT scan.

Age
Over 18 years
Sex
All sexes
Disease stage
Severe aortic stenosis on heart ultrasound at rest: valve area ≤ 1cm2 (or indexed ≤ 0.6 cm2/m2), OR peak velocity ≥ 4 m/s, OR mean gradient ≥ 40 mmHg. People must have symptoms: shortness of breath NYHA stage 2 or more, or an abnormal stress test. People without symptoms can join if heart pumping (LVEF) is < 50%. Blood vessels must allow valve placement through the groin artery.
Earlier treatment
People cannot join if they already have a pacemaker or triple chamber defibrillator, or an existing artificial heart valve in any position.

Main reasons for not taking part

  • Aortic valve with one or two leaflets (uni or bicuspid)
  • Severely weak heart pumping, LVEF < 30%
  • Other serious valve disease: aortic or mitral leak grade 3 or more, or tight mitral stenosis
  • Pregnant or breastfeeding
  • Expected to live < 12 months

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Patient with a pacemaker or triple chamber defibrillator prior to TAVI implantation
  • Patient with other significant valve disease : aortic insufficiency ≥ grade 3, mitral insufficiency ≥ grade 3 or tight mitral stenosis
  • Patient with severe left ventricular dysfunction LVEF < 30%
  • Patient with a uni or bicuspid aortic valve
  • 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 in France

  • CHU de BrestBrest, FranceContact: Romain Didier, DrTaking people

About the trial

What the trial wants to find out

Aortic valve stenosis is the most common valve disease leading to surgical or percutaneous intervention in Europe and North America. Percutaneous aortic valve replacement (TAVI) is currently recommended for the management of patients with symptomatic aortic stenosis and with high; very high operative risk of aortic valve replacement surgery or intermediate operative risk of aortic valve replacement surgery after a benefit-risk assessment by a heart team and operative contraindication to conventional aortic valve replacement surgery. These indications are supported by the 2017 European Cardiology guidelines.

Read full original descriptionShow less

This technique of percutaneous arterial valve implantation is most often performed via the femoral route, under local anesthesia, with placement of a prosthetic biological valve in the aortic position, impacting it into the patient's native aortic valve.

TAVI has been shown to be superior to medical treatment in patients with a aortic valve stenosis at very high operative risk of conventional aortic valve replacement surgery. However, the occurrence of atrioventricular conduction disorders (de novo left bundle branch block (LBBB) or complete AVB) remains the most frequent complication after TAVI. Therefore, the rate of pacemaker (PM) implantation after TAVI remains high, ranging from 2% to 51%, with an average rate of 13%.

Pacemaker implantation has several deleterious effects (increased hospitalization time, desynchronization of the left ventricle by permanent right ventricular pacing, exposure of the patient to procedural complications of pacemaker placement, and possible increase in the final cost to society of the initial hospitalization.

Not all patients who received a pacemaker post TAVI implantation use their PM. The rate of Pacemaker dependency and therefore of patients who actually use their pacemaker is approximately 33-36% at 1 year after percutaneous valve implantation.

In view of all the potentially deleterious consequences of post TAVI pacemaker implantation, it is therefore necessary to know which patients really justify pacemaker implantation after percutaneous valve implantation.

The purpose of this study is to investigate diagnostic imaging criteria that may be predictive of the occurrence of intramyocardial conduction disorders post TAVI implantation. Although some patients present only transient conductive disturbances, the impact of tissue inflammation of the intramyocardial conduction pathways after TAVI remains to be understood.

The group in the trial

  • InterventionTreatment being tested

    All patients will have to undergo an 18F-FDG PET-CT.

    Treatment: 18F-FDG PET-CT

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Impact of Local Tissue Inflammation on Intramyocardial Conduction Pathways Post Percutaneous Valve : Evaluation by Positron Emission Tomography on Exploratory Cohort
Plain-language title
PET scans of heart inflammation after percutaneous valve replacement for aortic valve stenosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
9 June 2026