Aortic Valve Stenosis Clinical Trials

Find Aortic Valve Stenosis Clinical Trials Near You

Transcatheter AortiC Valve Implantation in aorTic stenosIs CardiogenIc Shock - The TACTICS Study - A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Denmark
Rigshospitalet Copenhagen University Hospital
RECRUITING
Copenhagen O
Contact Information
Primary
Emil L Fosbøl, Professor, MD, PhD
emil.fosboel@regionh.dk
004535456340
Backup
Jarl E Strange, MD, PhD
jarl.emanuel.strange.02@regionh.dk
004560616598
Time Frame
Start Date: 2024-11-25
Estimated Completion Date: 2027-10-30
Participants
Target number of participants: 30
Treatments
Experimental: Acute TAVI
Acute TAVI within 12 hours.
Active_comparator: Standard treatment
TAVI no earlier than 72 hours.
Sponsors
Leads: Rigshospitalet, Denmark

This content was sourced from clinicaltrials.gov