Cardiac Function After Minimally Invasive Aortic Valve Implantation

Not Applicable

Completed

• Conditions: Aortic Valve Stenosis; Heart Valve Diseases
• Interventions: Procedure: Minimally invasive aortic valve replacement; Procedure: Conventional aortic valve replacement

• Registration Number: NCT01972555
• Lead Sponsor: Karolinska University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-21
• Study First Submitted QC: 2013-10-24
• Study First Posted: 2013-10-30
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-03
• Last Update Posted: 2016-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• ≥ 18 years of age
• Severe aortic stenosis defined as aortic valve area of less than 1 cm2 or index area of 0.6 cm2/m2 by echocardiography
• Referred for medically indicated aortic valve replacement
• Sinus rhythm
• Provide written informed consent

Exclusion Criteria

• Left ventricular ejection fraction less than 0.45
• Presence of any coexisting severe valvular disorder
• Previous cardiac surgery
• Urgent or emergent surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Minimally invasive aortic valve replacement	Minimally invasive aortic valve replacement	Minimally invasive AVR with either ministernotomy or anterior right-sided minithoracotomy will be performed according to current standard of care practices. Transthoracic echocardiography will be performed preoperatively and at day 1, 4, and 40.
Conventional aortic valve replacement	Conventional aortic valve replacement	Conventional AVR through a standard median sternotomy will be performed according to current standard of care practices. Transthoracic echocardiography will be performed preoperatively and at day 1, 4, and 40.

Primary Outcome Measures

Name	Time	Method
Right ventricular fractional area change	Preoperatively and postoperatively at day 4 and 40
Pulsed wave tissue Doppler right venricular velocity	Preoperatively and postoperatively at day 4 and 40
Tricuspid Annular Peak Systolic Excursion (TAPSE)	Preoperatively and postoperatively at day 4 and 40
Right ventricular dimensions	Preoperatively and postoperatively at day 4 and 40

Trial Locations

Locations (1)

Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital; 🇸🇪 Stockholm, Sweden