Preoperative Chest CT-imaging in Surgical Aortic Valve Replacement with or Without CABG

NCT06603454 | Recruiting DMC

• 1 other identifier: NL77700.100.21
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale When determining the strategy for aortic valve replacement, echocardiography is still considered the golden standard (1). While pre-procedural MSCT is standard of care in TAVR patients, this is not yet part of routine clinical practice in SAVR patients. The researchers hypothesise that when atherosclerosis of the ascending aorta is identified preoperatively on contrast-enhanced multi-slice computed tomography (MSCT), the subclinical perioperative stroke rate (as detected on diffusion-weighted magnetic resonance imaging (DW-MRI)) can be reduced by modification of the operative strategy if necessary.

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• Subclinical stroke rate

  Subclinical stroke rate (i.e., presence of new ischemic brain lesions) as identified with the use of DW-MRI made within one week postoperatively or before discharge (in case of prolonged ICU stay).

  Within 90 days post procedure

Secondary Outcomes (8)

• National Institutes of Health Stroke Scale

  within one week postoperatively (targeted at day two postoperatively)

• Clinical ischemic stroke (conform VARC-3)

  Within one week postoperatively

• TIA diagnosed by a neurologist

  One week postoperatively

• Change in intervention strategy

  After hospital admission but before the end of surgery

• Change in cannulation strategy

  During procedure

Study Arms (2)

Preoperative CT

ACTIVE COMPARATOR

Contrast-enhanced computed tomography of the aorta including the femoral arteries.

Radiation: Preoperative CT

No preoperative CT

NO INTERVENTION

Interventions

Preoperative CT RADIATION

Preoperative contrast enhanced CT

Preoperative CT

Eligibility Criteria

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

You may qualify if:

• Primary symptomatic severe aortic valve stenosis (defined as an aortic valve area of \<1.0cm2 and either a mean valve gradient of at least 40mmHg or a peak velocity of at least 4.0 m/s)
• Accepted for SAVR (either planned to be done by a limited access approach (partial J-shaped sternotomy or right anterior thoracotomy or conventional median sternotomy approach at the preference of the patient and/or the discretion of the surgeon) with or without concomitant CABG by the Heart Team
• Informed consent

You may not qualify if:

• Previous aortic valve replacement
• Emergency procedure
• Pregnant women
• Renal failure (eGFR \<30 ml/min.)
• Known contrast allergy
• Patient unwilling to be informed about unrequested findings on the CT scan or DW-MRI scan
• Contra-indication for MRI (e.g. permanent pacemaker or ICD that can not be inactivated per order of the pacemaker or ICD technician, morphine or insulin pump, neurostimulator). All patients will fill out a MRI checklist to additionally check for (new) safety contra-indications for MRI.
• Patient who did not agree to the informed consent and/or refused to participate
• Patient unable to understand the informed consent/study

Sponsors & Collaborators

• Romy Hegeman: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

St. Antonius Hospital

Nieuwegein, Utrecht, 3435 CM, Netherlands

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Patrick Klein, MD, PhD

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

• Prof. Jurriën C ten Berg, MD, PhD

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

• Martin C Swaans, MD, PhD

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Romy Hegeman, MD

CONTACT

+31 (0)6 41 71 16 79; r.hegeman@antoniusziekenhuis.nl

Simon van Putten, MD

CONTACT

+31 (0)88 320 12 13; s.van.putten@antoniusziekenhuis.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Coordinator

Study Record Dates

• First Submitted: July 27, 2024
• First Posted: September 19, 2024
• Study Start: December 4, 2023
• Primary Completion: April 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

NL (1)