Transcatheter AortiC Valve Implantation in AorTic StenosIs CardiogenIc Shock

NCT ID: NCT06638268

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-25
• Study Completion Date: 2027-07-01

Brief Summary

The goal of this clinical trial is to learn if acute transcatheter aortic valve implantation (TAVI) is superior to standard treatment (stabilization in an intensive care unit and TAVI subsequently) to treat cardiogenic shock in patients with critical severe aortic stenosis.

The main questions it aims to answer are:

• Does acute TAVI increase survival compared with standard treatment?

Participants will:

• Undergo either TAVI within 12 hours after admission or stabilization and TAVI 72 hours or more after admission
• Visit an outpatient clinic and be evaluated for quality of life and heart function

Detailed Description

Aortic stenosis (AS) is a condition where the heart's aortic valve narrows. With an estimated prevalence of 12% in individuals aged 75 years and above, it is the most common heart valve disease. The progressive narrowing increases the afterload on the heart, impairing its ability to maintain cardiac output. The end-stage of critical AS is cardiogenic shock (CS) with an incidence of 3.5% to 12%. Without treatment, patients develop acute decompensation, organ failure, and ultimately die.

Guidelines suggest balloon aortic valvuloplasty (BAV), hemodynamic optimization in the intensive care unit and surgical aortic valve replacement or transcatheter aortic valve implantation (TAVI) when the patient is stable. Even with BAV, the 30-day mortality is 33%-47% and a 1-year mortality is 70%. Further, the BAV procedure is associated with only a minor and likely temporary reduction in afterload due to elastic valvular tissue. Furthermore, the BAV procedure has been abandoned as a routine intervention in these patients due to a series of patients having limited immediate clinical response, a risk of deterioration and no impact on overall mortality risk. Moreover, most patients with critical AS in CS are not candidates for surgical aortic valve replacement because of increased peri-operative risk of morbidity and mortality.

Despite the recommendation on TAVI under stable conditions, an acute TAVI may be efficient in afterload reduction and more efficient than the limited and transient effects of BAV. TAVI has become an attractive alternative to surgery and BAV because of the less invasive nature of this procedure, yet permanent result (compared with BAV). It is already approved for the treatment of AS irrespective of CS status. This raises the question:

"Should acute TAVI be the new preferred treatment strategy in AS patients in Cardiogenic shock?"

In this randomized controlled trial, we will include patients with severe aortic stenosis and cardiogenic shock. Patients will undergo either acute TAVI or standard treatment (stabilization in a cardiac intensive care unit and subsequently TAVI) in a 1:1 ratio. Outcomes are evaluated 90 days after randomization and comprise days alive out of hospital, mortality, cardiac function, renal function, and quality of life.

Conditions

Aortic Stenosis; Cardiogenic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acute TAVI

Acute TAVI within 12 hours.

Group Type: EXPERIMENTAL

Acute TAVI

Intervention Type: PROCEDURE

TAVI must be performed as soon as possible and within 12 hours of admission to the heart center.

Standard treatment

TAVI no earlier than 72 hours.

Group Type: ACTIVE_COMPARATOR

Stabilization and subacute TAVI

Intervention Type: OTHER

Patients are stabilized according to target parameters. Treatment may include vasopressor, mechanical ventilation, renal replacement therapy, and blood transfusion. TAVI is then performed no earlier than 72 hours of admission to heart center.

Interventions

Acute TAVI

TAVI must be performed as soon as possible and within 12 hours of admission to the heart center.

Intervention Type: PROCEDURE

Stabilization and subacute TAVI

Patients are stabilized according to target parameters. Treatment may include vasopressor, mechanical ventilation, renal replacement therapy, and blood transfusion. TAVI is then performed no earlier than 72 hours of admission to heart center.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Aortic valve area less than 1cm2

AND

Cardiogenic Shock defined as:

• Peripheral signs of tissue hypoperfusion (arterial blood lactate ≥2.5mmol/l) AND
• Systolic blood pressure < 100 mmHg and/or need for vasopressor therapy (dopamine/ norepinephrine or epinephrine) AND
• Left ventricular ejection fraction ≤ 45%

OR

• Syncope/resuscitation (mechanical ventilation)

Exclusion Criteria

• Intracranial hemorrhage < 1 month ago
• Remaining life-expectancy < 6 month due to other cause
• Body mass index <15 OR > 40
• Clinical frailty score ≥6 before present worsening
• Severe lung disease (forced expiratory volume in 1 second OR diffusion capacity of the lungs for carbon monoxide < 25 of expected)
• Unsuitable for TAVI prior to screening

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Odense University Hospital

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Emil Loldrup Fosbol

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rigshospitalet Copenhagen University Hospital

Copenhagen O, , Denmark

Odense University Hospital

Odense C, , Denmark

Countries

Denmark

Central Contacts

Emil L Fosbøl, Professor, MD, PhD

Role: CONTACT

emil.fosboel@regionh.dk

004535456340

Jarl E Strange, MD, PhD

Role: CONTACT

jarl.emanuel.strange.02@regionh.dk

004560616598

Facility Contacts

Emil L Fosbøl, Professor, MD, PhD

Role: primary

emil.fosboel@regionh.dk

004535456340

Emil L Fosbøl, Professor, MD, PhD

Role: backup

Jesper Kjærgaard, Associate professor, DMSc, MD

Role: backup

Jacob E Møller, DMSc, MD, PhD

Role: primary

jacob.moeller1@rsyd.dk

Jacob E Møller, DMSc, MD, PhD

Role: backup

Other Identifiers

H-24052460

Identifier Type: -

Identifier Source: org_study_id