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Cardiac Function After Minimally Invasive Aortic Valve Implantation

NCT01972555 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-08-04

No results posted yet for this study

Summary

This is a single-center, open-label, randomized controlled trial. Patients scheduled for aortic valve replacement (AVR) at Karolinska University Hospital in Stockholm, Sweden will be eligible. Forty patients will be randomly assigned to either minimally invasive (20 patients) or conventional AVR (20 patients). CE-marked and FDA-approved mechanical and bioprosthetic aortic valves (conventional stented or sutureless bioprostheses) will be implanted. Transthoracic echocardiography will be performed before surgery, and at day 1, 4, and 40. Echocardiographic parameters as well as preoperative clinical characteristics and postoperative clinical outcomes will be registered. Routine blood sampling will be performed pre- and postoperatively. All available data will be collected prospectively. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.

Conditions

  • Aortic Valve Stenosis
  • Heart Valve Diseases

Interventions

PROCEDURE

Minimally invasive aortic valve replacement

PROCEDURE

Conventional aortic valve replacement

Sponsors & Collaborators

Principal Investigators

  • Ulrik Sartipy, MD, PhD · Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital

  • Reidar Winter, MD, PhD · Department of Cardiology, Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Sweden

Study Locations

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Entities

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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 NCT01972555 on ClinicalTrials.gov