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Left vs. Right Radial Approach for Routine Catheterization of Heart Transplant Patients

NCT02163031 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-07-26

No results posted yet for this study

Summary

Orthotopic heart transplantation is a well established therapeutic measure for end stage heart failure, leading to significant improvements in survival and quality of life. In the routine clinical practice, orthotopic heart transplantation patients receive periodic cardiac catheterization for early detection of allograft vascular disease.

The coronary angiography of these patients is characterized for several technical difficulties, generally related to the presence of the aortotomy with anomalous implantation of the coronary ostia and to the orthotopic position of the allograft. For these reasons, trans femoral approach is usually preferred. In the last two decades, trans radial approach for coronary angiography emerged to be effective, safe and able to improve patient comfort. However, there is no universal consensus on the optimal choice of radial access from either the left or the right artery. Currently, this choice is largely dependent on the operator's preference. The trans right radial approach is generally preferred in routine clinical practice mainly due to its easier catheter manipulation for the operators from patient's right side, and the current design of radial compression devices for the right wrist in medical market. As such, a major barrier to prevent the wide adoption of the left radial access lies in some difficulty to reach the left wrist leaning over the patient, particularly for shorter operators or in obese patients. However, a great deal of attention has been recently directed toward the trans left radial access, as it has an important anatomical advantage due to the vascular anatomy of epiaortic vessels with a straighter route to the left coronary ostium, which could also reduce the risk of cerebrovascular complications.

However, no data are available about the performance of trans left radial or trans-right radial approach in coronary angiography orthotopic heart transplantation patients. However, in this particular setting of patients, the left radial approach might reduce the technical difficulties related to the anatomical variations.

In this single centre, prospective, randomized study, we sought to compare trans right radial versus trans left radial approach in terms of amount of contrast medium, radiation exposure, number of catheters used, cross over to the other access site rate and local and systemic complications in orthotopic heart transplantation patients.

Conditions

Interventions

DEVICE

devices used in the coronary angiography

devices used in coronary angiography by left or right radial route

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    lead OTHER

Principal Investigators

  • Manel Sabatè · Hospital Clinic of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-12-31
Completion
2017-01-31

Countries

  • Spain

Study Locations

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Entities

Diseases

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 NCT02163031 on ClinicalTrials.gov