Impact of local tissue inflammation on intramyocardial conduction pathways post percutaneous valve : evaluation by positron emission tomography on exploratory cohort

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Regional Et Universitaire De Brest

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

17 Jun 2024 → ongoing

Decision date (initial)

2024-06-17

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-514587-44-00

EudraCT number

2021-004457-23

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

To study the association between the occurrence of conduction disorders after percutaneous aortic valve and the degree of inflammation of intramyocardial conduction pathways assessed by 18F-FDG PET-CT, based on observation of subjects in an exploratory cohort.

Secondary objectives 2

1. To study the association between the degree of intramyocardial conduction pathway inflammation assessed by 18F-FDG PET-CT and the need for pacemaker implantation after percutaneous aortic valve implantation
2. Identification of predictive factors for pacemaker dependence at 1 and 6 months

Conditions and MedDRA coding

Aortic stenosis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Patients over 18 years of age
2. Patient with tight aortic stenosis defined by aortic valve area ≤ 1cm2 (or indexed aortic valve area ≤ 0.6 cm2/m2 body surface area), OR maximum transvalvular velocity ≥ 4 m/s OR mean transvalvular gradient ≥ 40 mmHg, assessed by transthoracic echocardiography (TTE) performed in a patient at rest
3. Symptomatic patient with: dyspnea ≥ stage 2 according to New York Heart Association (NYHA) classification OR pathological stress test with onset of symptoms on exertion, drop in blood pressure or rhythm disturbance on exertion OR Asymptomatic with Left Ventricular Ejection Fraction (LVEF) < 50%
4. Patient with vascular anatomy compatible with percutaneous femoral valve implantation
5. Patient affiliated to or benefiting from a health insurance scheme
6. Patient has provided free, informed and written consent

Exclusion criteria 11

1. Patients with pacemakers or triple-chamber defibrillators prior to TAVI (Transcatheter Aortic Valve Implantation) implantation
2. Patients with a uni or bicuspid aortic valve
3. Patients with severe left ventricular dysfunction (LVEF < 30%)
4. Patients with other significant valvulopathies: aortic insufficiency ≥ grade 3, mitral insufficiency ≥ grade 3 or tight mitral stenosis
5. Patient with iliofemoral vascular anatomy preventing safe passage of valve
6. Patient with pre-existing TAVI bioprosthesis or mechanical prosthesis, in any position
7. Inability or refusal to give consent
8. Pregnant or breast-feeding woman
9. Patients under court protection or family guardianship
10. Patient deprived of liberty by judicial or administrative decision, under guardianship or trusteeship
11. Patient with life expectancy < 12 months

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Intra-hospital "occurrence of a conductive disorder", a composite criterion comprising: 1) complete AVB, 2) high-grade AVB, 3) LBB, 4) RBB, 5) AVB1; assessed by electrocardiograms (ECG post percutaneous valve implantation) performed during the initial hospitalization

Secondary endpoints 3

1. Post-TAVI pacemaker implantation
2. Post-TAVI pacemaker dependence at 1 month, 6 months
3. "Occurrence of a conductive disorder" within 6 months of discharge from TAVI hospitalization

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Regional Et Universitaire De Brest

Sponsor organisation

Centre Hospitalier Regional Et Universitaire De Brest

Address

5 Avenue Marechal Foch, Bp 824 Bp 824

City

Brest Cedex 2

Postcode

29609

Country

France

Scientific contact point

Organisation

Centre Hospitalier Regional Et Universitaire De Brest

Contact name

Pr Romain DIDIER

Public contact point

Organisation

Centre Hospitalier Regional Et Universitaire De Brest

Contact name

Pr Romain DIDIER

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications