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VARC-TAVI VALVE IMPLANTATION)

NCT06177392 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2024-01-05

No results posted yet for this study

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

Interventions

PROCEDURE

Secondary TAVI access

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

Sponsors & Collaborators

  • Hospital Universitario La Paz

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-08
Primary Completion
2025-10-01
Completion
2025-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06177392 on ClinicalTrials.gov