Impact of Local Tissue Inflammation on Intramyocardial Conduction Pathways Post Percutaneous Valve : Evaluation by Positron Emission Tomography on Exploratory Cohort (IMPACT)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Diagnostic test: 18F-FDG PET-CT

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Romain Didier, Dr; Phone Number: +33 298347392; Email: romain.didier@chu-brest.fr

Study Locations

• France
  • Brest, France, 29609
    • Recruiting
    • CHU de Brest
    • Contact: Romain Didier, Dr; Phone Number: +33 298347392; Email: romain.didier@chu-brest.fr
    • Principal Investigator: Romain Didier, Dr
    • Sub-Investigator: Martine Gilard, Dr
    • Sub-Investigator: Pierre-Philippe Nicol, Dr
    • Sub-Investigator: Clément Benic, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; All patients will have to undergo an 18F-FDG PET-CT.	Diagnostic test: 18F-FDG PET-CT; The 18F-FDG PET-CT will be performed in the nuclear medicine department of the CHU of Brest. For this exam, the administration of 2-3 MBq/kg of 18F-FDG ([18F]F-fluorodeoxyglucose) will be performed to the patient in a single intravenous injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of a conductive disorder	The primary end point is "occurrence of conductive disturbance": 1) complete BAV, 2) high-grade BAV, 3) LBBB, 4) RBBB, 5) BAV1; assessed by the performance of post-percutaneous valve implantation electrocardiograms (ECGs) during the initial patient's hospitalization.	Up to 5 days after TAVI's implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants requiring pacemaker implantation	Number of participants requiring pacemaker implantation post-TAVI	Up to 5 days after TAVI's implantation, 1, 6 and 12 months
Simulation rate of pacemaker	Simulation rate of the right ventricular lead of the pacemaker at 1 and 6 months after TAVI's implantation	1 and 6 month
Occurrence of a conductive disorder	Occurrence of a conductive disorder (atrioventricular blocks or high-grade atrioventricular block or left buncle branch block or right bundle branch block or atrioventricular block grade 1) within 6 months of discharge from TAVI's hospitalization.	6 month

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2022
• Primary Completion (Estimated): November 23, 2027
• Study Completion (Estimated): November 23, 2028

Study Registration Dates

• First Submitted: March 15, 2022
• First Submitted That Met QC Criteria: March 24, 2022
• First Posted (Actual): April 4, 2022

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: TAVI
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Fluorodeoxyglucose F18
• Other Study ID Numbers: 29BRC21.0255 (IMPACT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient.
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of BrestUH. Requestors will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No