VARC-TAVI VALVE IMPLANTATION)

NCT06177392 | Unknown

• 1 other identifier: VARC-TAVI 6571-2023.735
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

SUMMARY: The investigators are planning a clinical study to compare two methods of performing a procedure called TAVI, used in patients with severe aortic stenosis. In this procedure, the aortic valve is replaced in a less invasive way. Traditionally, access through the groin (femoral) is used, but now radial access (through the wrist) is being considered as an alternative. Reasons for the Study:

• Currently, there is not enough solid evidence to support the choice between these two accesses.
• The investigators want to understand if radial access could be safer and have fewer complications compared to femoral access. What the Investigators Will Measure:
• Major complications, such as bleeding or vascular injuries.
• Other important outcomes, such as functional recovery and quality of life. How the Investigators Will Do It:
• The investigators will randomize patients to receive radial or femoral access.
• The investigators will record which type of access is used and assess complications and outcomes.
• The investigators will compare the results to understand if there are significant differences between the two groups. Ultimate Goal:
• The investigators aim to improve the safety and efficacy of this procedure for patients.
• The results of this study will help doctors make informed decisions on how to perform TAVI. Conclusion: \- This study is crucial for enhancing care for patients with aortic stenosis and ensuring the procedure is performed in the safest and most effective manner. The results will benefit patients and guide doctors in choosing the best approach for each individual.

Conditions

Severe Aortic Stenosis; TAVI\(Transcatheter Aortic Valve Implantation\); Vascular Complications

Keywords

RADIAL ACCESS; RADIAL SECONDARY ACCESS; TAVI; SEVERE AORTIC STENOSIS; VASCULAR COMPLICATIONS; VARC-3

Outcome Measures

Primary Outcomes (1)

• ACCESS RELATED OR BLEEDING COMPLICATIONS

  Major and minor access-related complications (VARC-3) and major or greater (VARC ≥2) bleeding complications (BARC)

  From the enrollment to 4 weeks after the procedure.

Secondary Outcomes (4)

• MACE

  From the enrollment to 4 weeks after the procedure.

• bleeding

  From the enrollment to 4 weeks after the procedure.

• Quality of life scale

  4 weeks after the procedure

• Complications not directly TAVI procedure-related

  From the enrollment to 4 weeks after the procedure.

Study Arms (2)

RADIAL

EXPERIMENTAL

RADIAL ARTERY ACCESS AS SECONDARY ACCESS IN TAVI PROCEDURE

Procedure: Secondary TAVI access

FEMORAL

ACTIVE COMPARATOR

FEMORAL ARTERY ACCESS AS SECONDARY ACCESS IN TAVI PROCEDURE

Procedure: Secondary TAVI access

Interventions

Secondary TAVI access PROCEDURE

The randomization will determine whether radial or femoral artery puncture will be employed as the secondary access in the TAVI procedure.

FEMORAL; RADIAL

Eligibility Criteria

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

You may qualify if:

• Adult patients with severe aortic stenosis and candidates for transfemoral TAVI.
• Secondary access possible through both radial and femoral routes.
• Capacity to provide informed consent.

You may not qualify if:

• Specific contraindications for radial or femoral access.

Sponsors & Collaborators

• Hospital Universitario La Paz: lead

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Daniel Tébar Márquez DTM Daniel Tébar Márquez, MD

CONTACT

+034 695-86-03-09; daniel.tebar.m@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of medicine

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 20, 2023
• Study Start: January 8, 2024
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 5, 2024

Record last verified: 2024-01