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

NCT05308888 | Unknown Phase 2 DMC

• 1 other identifier: 29BRC21.0255 (IMPACT)
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aortic Valve Stenosis

Keywords

TAVI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of participants requiring pacemaker implantation

  Up to 5 days after TAVI's implantation, 1, 6 and 12 months

• Simulation rate of pacemaker

  1 and 6 month

• Occurrence of a conductive disorder

  6 month

Study Arms (1)

Intervention

EXPERIMENTAL

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

Diagnostic Test: 18F-FDG PET-CT

Interventions

18F-FDG PET-CT DIAGNOSTIC_TEST

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHU de Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Central Study Contacts

Romain Didier, Dr

CONTACT

298347392; romain.didier@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: April 4, 2022
• Study Start: May 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2024
• Last Updated: April 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient.
• 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.

Locations

FR (1)