Rule Out Transcatheter Aortic Valve Thrombosis With Post Implantation Computed Tomography (RETORIC)

NCT02826200 | Unknown Phase 4 DMC

• 1 other identifier: The RETORIC study
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The RETORIC study is a prospective cohort study with a primary aim to assess the incidence and independent predictors of reduced leaflet motion and valve thrombosis after TAVI procedure using multimodality imaging strategy comprising cardiac CT, transesophageal echocardiography (TEE) and transthoracic echocardiography (TTE). As a secondary aim we will assess the incidence of stroke and transient ischemic attack (TIA) in patients with reduced leaflet motion and/or thrombosis when compared with those with normal leaflet function. In addition we will randomize patients with reduced leaflet motion and/or valve thrombosis to single antiplatelet therapy plus oral anticoagulation therapy versus standard therapy. The primary outcome of the nested randomized trial will be the presence of reduced leaflet motion and/or valve thrombosis after 4 months, the secondary outcome is the presence of ischemic changes in brain demonstrated by MRI.

Conditions

Prosthetic Cardiac Valve Thrombosis; Cerebrovascular Accident; Prosthetic Valve Malfunction

Keywords

Transcatheter aortic valve implantation; Transcatheter aortic valve replacement; Prosthetic Cardiac Valve Thrombosis; Cerebrovascular Accident; Prosthetic Valve Malfunction; Four-dimensional volume rendered cardiac CT; Transesophageal echocardiography; Transthoracic echocardiography; Brain MRI

Outcome Measures

Primary Outcomes (1)

• Reduced leaflet motion and/or valve thrombosis

  4 months

Secondary Outcomes (1)

• Presence of ischemic brain lesions

  4 months

Study Arms (2)

Group 1 (SOC+OAT)

EXPERIMENTAL

Patients with reduced leaflet motion or with prosthetic heart valve thrombosis receiving single antiplatelet therapy plus oral anticoagulant therapy.

Drug: Acenocoumarol; Other: Standard of care

Group 2 (SOC)

ACTIVE COMPARATOR

Patients with reduced leaflet motion or with prosthetic heart valve thrombosis receiving standard of care therapy.

Other: Standard of care

Interventions

Acenocoumarol DRUG

Standard of care plus oral anticoagulant therapy (acenocoumarol)

Group 1 (SOC+OAT)

Standard of care OTHER

Standard of care

Group 1 (SOC+OAT); Group 2 (SOC)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• TAVI procedure
• Signed ethics committee-approved informed consent form

You may not qualify if:

• Age under 18 years
• Patients for whom multidetector-row computed tomography is contraindicated per institutional standard of care (History of severe and/or anaphylactic contrast reaction, severe renal insufficiency, inability to cooperate with scan acquisition and/or breathhold instructions)
• Patients diagnosed with infective endocarditis since TAVI procedure

Sponsors & Collaborators

• Semmelweis University Heart and Vascular Center: lead

Study Sites (1)

Heart and Vascular Center, Semmelweis University

Budapest, 1122, Hungary

RECRUITING

Related Publications (5)

• Makkar RR, Fontana G, Jilaihawi H, Chakravarty T, Kofoed KF, De Backer O, Asch FM, Ruiz CE, Olsen NT, Trento A, Friedman J, Berman D, Cheng W, Kashif M, Jelnin V, Kliger CA, Guo H, Pichard AD, Weissman NJ, Kapadia S, Manasse E, Bhatt DL, Leon MB, Sondergaard L. Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves. N Engl J Med. 2015 Nov 19;373(21):2015-24. doi: 10.1056/NEJMoa1509233. Epub 2015 Oct 5.

  PMID: 26436963 BACKGROUND

• Apor A, Bartykowszki A, Szilveszter B, Varga A, Suhai FI, Manouras A, Molnar L, Jermendy AL, Panajotu A, Turani MF, Papp R, Karady J, Kolossvary M, Kovats T, Maurovich-Horvat P, Merkely B, Nagy AI. Subclinical leaflet thrombosis after transcatheter aortic valve implantation is associated with silent brain injury on brain magnetic resonance imaging. Eur Heart J Cardiovasc Imaging. 2022 Nov 17;23(12):1584-1595. doi: 10.1093/ehjci/jeac191.

  PMID: 36168113 DERIVED

• Varga A, Gyebnar G, Suhai FI, Nagy AI, Kozak LR, Poka CA, Turani MF, Borzsak S, Apor A, Bartykowszki A, Szilveszter B, Kolossvary M, Maurovich-Horvat P, Merkely B. Microstructural alterations measured by diffusion tensor imaging following transcatheter aortic valve replacement and their association with cerebral ischemic injury and cognitive function - a prospective study. Neuroradiology. 2022 Dec;64(12):2343-2356. doi: 10.1007/s00234-022-03017-5. Epub 2022 Aug 1.

  PMID: 35915181 DERIVED

• Vattay B, Nagy AI, Apor A, Kolossvary M, Manouras A, Vecsey-Nagy M, Molnar L, Boussoussou M, Bartykowszki A, Jermendy AL, Kovats T, Zsarnoczay E, Maurovich-Horvat P, Merkely B, Szilveszter B. The Predictive Value of Left Atrial Strain Following Transcatheter Aortic Valve Implantation on Anatomical and Functional Reverse Remodeling in a Multi-Modality Study. Front Cardiovasc Med. 2022 Apr 25;9:841658. doi: 10.3389/fcvm.2022.841658. eCollection 2022.

  PMID: 35548439 DERIVED

• Karady J, Apor A, Nagy AI, Kolossvary M, Bartykowszki A, Szilveszter B, Simon J, Molnar L, Jermendy AL, Panajotu A, Suhai FI, Varga A, Rajani R, Maurovich-Horvat P, Merkely B. Quantification of hypo-attenuated leaflet thickening after transcatheter aortic valve implantation: clinical relevance of hypo-attenuated leaflet thickening volume. Eur Heart J Cardiovasc Imaging. 2020 Dec 1;21(12):1395-1404. doi: 10.1093/ehjci/jeaa184.

  PMID: 32756984 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Acenocoumarol; Standard of Care

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Béla Merkely, MD, PhD, DSc

  Semmelweis University Heart and Vascular Center

  PRINCIPAL INVESTIGATOR

• Pál Maurovich-Horvat, MD, PhD, MPH

  Semmelweis University Heart and Vascular Center

  PRINCIPAL INVESTIGATOR

• Ronak Rajani, MD MRCP BM

  Guy's and St Thomas' NHS Foundation Trust, Kings College London

  STUDY CHAIR

Central Study Contacts

Pál Maurovich-Horvat, MD, PhD, MPH

CONTACT

+36206632485; p.maurovich-horvat@cirg.hu

Astrid Apor, MD

CONTACT

+36208258004; aporastrid@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 7, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: January 1, 2019
• Last Updated: January 18, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)