Clinical trial NCT06449469: The Nordic Aortic Valve Intervention Trial 4 (NOTION-4)
Official title: Prospective Study on the Impact of Different Anti-thrombotic Therapies on Subclinical Leaflet Thickening and Its Temporal Dynamics in Transcatheter Bioprosthetic Aortic Valves (NOTION-4)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aortic Valve Stenosis
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases
Valve Disease, Aortic
Keywords: heart valve disease
valvular bioprosthesis
aortic valve replacement
Randomized clinical trial
TAVI
Antitrombotic medication
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital Skejby
First posted: 2024-06-10
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized clinical trial investigating the incidence and temporal dynamics of subclinical leaflet thickening by cardiac CT in transcatheter bioprosthetic aortic valves in patients randomised to different anti-thrombotic strategies. Additionally, this study aims to examine a possible association between HALT and thromboembolic events.

Detailed description: The NOTION-4 trial is an investigator-initiated, randomized, open label, comparative trial conducted at Rigshospitalet in Copenhagen and Skejby Sygehus in Aarhus. All adult patients that have undergone successful TAVI without contraindications for cardiac CT will be invited to participate in this study. Patients with SR and without known other indication for chronic OAC therapy will be randomized 1:1 either to lifelong ASA or to 3 months of DOAC followed by lifelong ASA. Patients with known AF will be randomized 1:1 to lifelong DOAC versus LAAC within 3 months followed by lifelong ASA.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent successful TAVI according to Valve Academic Research Consortium (VARC)-2 criteria
* Residing in Denmark
* Provided written informed consent

Exclusion Criteria:

* Atrial fibrillation or any other indication for lifelong oral anticoagulant therapy
* Patient deemed not suitable for DOAC treatment because of previous life-threatening or major bleeding, e.g. intracranial haemorrhage or major gastrointestinal bleeding
* Patients with severe renal insufficiency (eGFR \<30 mL/min/1.73 m2)
* Patient with absolute indication for anti-thrombotic therapy, e.g. recent PCI
* Iodine contrast allergy or other condition that prohibits CT imaging
* Age \<18 years
* Women of childbearing potential, pregnant or nursing

Primary outcomes:
measure: HALT after 1 year
timeFrame: At 1 year after TAVI
Secondary outcomes:
measure: Combined clinical endpoint of all-cause mortality, thromboembolic event, and life-threatening or major bleeding
timeFrame: At 1 year and 5 years after TAVI
measure: Incidence of patients with HALT during follow up
timeFrame: At 3 months, 1 year and 5 years after TAVI
measure: HALT on leaflets
timeFrame: At 3 months, 1 year and 5 years after TAVI
measure: Number of participants with ischemic stroke
timeFrame: At 3 months, 1 year and 5 years after TAVI
measure: Number of participants with stroke
timeFrame: At 3 months, 1 year and 5 years after TAVI
measure: Number of participants with all-cause death
timeFrame: At 3 months, 1 year and 5 years after TAVI
measure: Number of participants with cardiovascular mortality
timeFrame: At 3 months, 1 year and 5 years after TAVI
measure: Number of participants with bleeding
timeFrame: At 3 months, 1 year and 5 years after TAVI
measure: Number of participants with re-intervention
timeFrame: At 3 months, 1 year and 5 years after TAVI
measure: Number of participants with aortic bioprosthetic dysfunction
timeFrame: At 3 months, 1 year and 5 years after TAVI
measure: Number of participants with bioprosthetic valve failure
timeFrame: At 3 months, 1 year and 5 years after TAVI
measure: NYHA classification
timeFrame: At 3 months, 1 year and 5 years after TAVI
measure: Quality of life scores with 5-level EQ-5D version (EQ5D-5L)
timeFrame: At 3 months, 1 year and 5 years after TAVI
measure: Quality of life scores with EQ Visual Analogue Scale (EQ VAS)
timeFrame: At 3 months, 1 year and 5 years after TAVI
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Skejby
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospital, Denmark
name: Ole De Backer, PhD
role: PRINCIPAL_INVESTIGATOR
References: