NCT01972555

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 30, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

August 4, 2016

Status Verified

August 1, 2016

Enrollment Period

1.7 years

First QC Date

October 21, 2013

Last Update Submit

August 3, 2016

Conditions

Aortic Valve StenosisHeart Valve Diseases

Outcome Measures

Primary Outcomes (4)

  • Tricuspid Annular Peak Systolic Excursion (TAPSE)

    Preoperatively and postoperatively at day 4 and 40

  • Right ventricular fractional area change

    Preoperatively and postoperatively at day 4 and 40

  • Right ventricular dimensions

    Preoperatively and postoperatively at day 4 and 40

  • Pulsed wave tissue Doppler right venricular velocity

    Preoperatively and postoperatively at day 4 and 40

Study Arms (2)

Minimally invasive aortic valve replacement

EXPERIMENTAL

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.

Procedure: Minimally invasive aortic valve replacement

Conventional aortic valve replacement

ACTIVE COMPARATOR

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.

Procedure: Conventional aortic valve replacement

Interventions

Minimally invasive aortic valve replacementPROCEDURE
Minimally invasive aortic valve replacement
Conventional aortic valve replacementPROCEDURE
Conventional aortic valve replacement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital

Stockholm, Sweden

Location

Related Publications (1)

  • Dalen M, Oliveira Da Silva C, Sartipy U, Winter R, Franco-Cereceda A, Barimani J, Back M, Svenarud P. Comparison of right ventricular function after ministernotomy and full sternotomy aortic valve replacement: a randomized study. Interact Cardiovasc Thorac Surg. 2018 May 1;26(5):790-797. doi: 10.1093/icvts/ivx422.

    PMID: 29325064DERIVED

MeSH Terms

Conditions

Aortic Valve StenosisHeart Valve Diseases

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Ulrik Sartipy, MD, PhD

    Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital

    STUDY CHAIR

  • Reidar Winter, MD, PhD

    Department of Cardiology, Karolinska University Hospital

    STUDY CHAIR

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
MD, PhD

Study Record Dates

First Submitted

October 21, 2013

First Posted

October 30, 2013

Study Start

October 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

August 4, 2016

Record last verified: 2016-08

Locations

SE(1)