INTERvention With Cerebral Embolic Protection in Transcatheter Aortic Valve Implantation (INTERCEPTavi)

NCT05146037 | Unknown

• 1 other identifier: 20HH6479
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate the processes of a pilot single-centre randomised controlled trial (RCT) of carbon-dioxide flushing of transcatheter aortic valves (TAVI-CO2) versus standard saline flushing of valves (TAVI-S) and assess potential neuroprotection through a number of neurological endpoints for planning of a full-sized RCT

Conditions

Stroke; Aortic Valve Stenosis; Silent Cerebral Infarct; Vascular Brain Injury

Keywords

Stroke; Aortic Valve Stenosis; Silent Cerebral Infarct; Vascular Brain Injury; TAVI; Transcatheter aortic valve implantation; Transcranial doppler; Magnetic resonance imaging; CO2; Carbon dioxide

Outcome Measures

Primary Outcomes (1)

• Number of participants suitable for recruitment for larger RCT

  Conduct an evaluation of the processes described in this pilot RCT for a full-scale RCT including: 1. Screening, Recruitment and Randomisation 2. Retention in follow-up assessments 3. Study design for a full RCT and identification of important stratification variables 4. Refine sample size calculation for a full RCT

  Duration of study, approximately 15 months

Secondary Outcomes (1)

• Incidence of Vascular Brain Injury (VBI) on Diffusion Weighted-Magnetic Resonance Imaging (DW-MRI)

  Post TAVI 1-7 days and 6-months post TAVI

Other Outcomes (4)

• Detection of periprocedural cerebral solid and gaseous emboli

  During TAVI procedure

• Neurological deficit

  6 Months

• Inflammatory biomarker assessing brain injury

  24 hours post TAVI

Study Arms (2)

Saline flushing

ACTIVE COMPARATOR

TAVI valves will be prepared according to instruction for use(IFU) with saline flushing only.

Other: Saline flushing

CO2 and saline flushing

EXPERIMENTAL

TAVI valves will be flushed with CO2 and then saline as per IFU

Other: CO2 and saline flushing

Interventions

CO2 and saline flushing OTHER

TAVI valves will be prepared by flushing with CO2 to displace any retained air during manufacturing and preparation. The valves will then be flushed with saline as per IFU.

CO2 and saline flushing

Saline flushing OTHER

TAVI valves will be flushed with saline only as per IFU.

Saline flushing

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients between the ages of 18 and 100 years undergoing transcatheter aortic valve implantation (TAVI) for aortic stenosis under local anaesthetic.

You may not qualify if:

• Patients that lack capacity to provide informed consent
• Patients that have had a stroke within 12 months
• Patients aged less than 18 years of age
• Patients that are pregnant

Sponsors & Collaborators

• Imperial College London: lead
• Imperial College Healthcare NHS Trust: collaborator

Study Sites (1)

Imperial College London

London, United Kingdom

RECRUITING

Related Publications (5)

• Inci K, Koutouzi G, Chernoray V, Jeppsson A, Nilsson H, Falkenberg M. Air bubbles are released by thoracic endograft deployment: An in vitro experimental study. SAGE Open Med. 2016 Dec 7;4:2050312116682130. doi: 10.1177/2050312116682130. eCollection 2016.

  PMID: 27994872 BACKGROUND

• Rohlffs F, Tsilimparis N, Saleptsis V, Diener H, Debus ES, Kolbel T. Air Embolism During TEVAR: Carbon Dioxide Flushing Decreases the Amount of Gas Released from Thoracic Stent-Grafts During Deployment. J Endovasc Ther. 2017 Feb;24(1):84-88. doi: 10.1177/1526602816675621. Epub 2016 Oct 26.

  PMID: 27798380 BACKGROUND

• Martens S, Neumann K, Sodemann C, Deschka H, Wimmer-Greinecker G, Moritz A. Carbon dioxide field flooding reduces neurologic impairment after open heart surgery. Ann Thorac Surg. 2008 Feb;85(2):543-7. doi: 10.1016/j.athoracsur.2007.08.047.

  PMID: 18222261 BACKGROUND

• Bismuth J, Garami Z, Anaya-Ayala JE, Naoum JJ, El Sayed HF, Peden EK, Lumsden AB, Davies MG. Transcranial Doppler findings during thoracic endovascular aortic repair. J Vasc Surg. 2011 Aug;54(2):364-9. doi: 10.1016/j.jvs.2010.12.063. Epub 2011 Mar 3.

  PMID: 21371850 BACKGROUND

• Perera AH, Rudarakanchana N, Monzon L, Bicknell CD, Modarai B, Kirmi O, Athanasiou T, Hamady M, Gibbs RG. Cerebral embolization, silent cerebral infarction and neurocognitive decline after thoracic endovascular aortic repair. Br J Surg. 2018 Mar;105(4):366-378. doi: 10.1002/bjs.10718. Epub 2018 Feb 12.

  PMID: 29431856 BACKGROUND

MeSH Terms

Conditions

Stroke; Aortic Valve Stenosis; Cerebrovascular Trauma

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Ventricular Outflow Obstruction; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Ghada Mikhail

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saud Ahmed Khawaja, MBBS

CONTACT

+44 203 313 1626; Saud.khawaja@nhs.net

Ghada Mikhail, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients and outcome assessors will be blinded to intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomised to CO2 and Saline flushing versus saline flushing only.

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: December 6, 2021
• Study Start: September 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 26, 2023

Record last verified: 2023-01

Locations

GB (1)