Clinical trial NCT01972555: Cardiac Function After Minimally Invasive Aortic Valve Implantation
Official title: Single-center Randomized Controlled Trial of Cardiac Function After Minimally Invasive Aortic Valve Implantation (CMILE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Heart Valve Diseases
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2013-10-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Tricuspid Annular Peak Systolic Excursion (TAPSE)
timeFrame: Preoperatively and postoperatively at day 4 and 40
measure: Right ventricular fractional area change
timeFrame: Preoperatively and postoperatively at day 4 and 40
measure: Right ventricular dimensions
timeFrame: Preoperatively and postoperatively at day 4 and 40
measure: Pulsed wave tissue Doppler right venricular velocity
timeFrame: Preoperatively and postoperatively at day 4 and 40
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital
Study officials:
affiliation: Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital
name: Ulrik Sartipy, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Cardiology, Karolinska University Hospital
name: Reidar Winter, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.