Patient Reported Health-Related Quality of Life After Limited Access and Conventional Aortic Valve Replacement: Design and Rationale of the LIAR-Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 2
- 主要终点
- Changes in cardiac-specific quality of life after aortic valve replacement.
研究概览
简要总结
The LIAR-Trial is a single-center, single blind randomized controlled clinical trial comparing patients undergoing isolated AVR via J-shaped upper hemi-sternotomy (UHS) and conventional AVR through a full median sternotomy (FMS). Primary outcome is cardiac-specific quality of life, measured by two domains of the Kansas City Cardiomyopathy Questionnaire (KCCQ), up to one year after surgery.
详细描述
The LIAR-Trial is a single-center, single blind randomized controlled clinical trial comparing patients undergoing isolated AVR via J-shaped upper hemi-sternotomy (UHS) and conventional AVR through a full median sternotomy (FMS). To reduce potential confounding by differences in implanted valve prostheses, in both arms of the trail, the diseased native aortic valve is planned to be replaced with a rapid deployment stented aortic bioprosthesis (Edwards Intuity Elite Valve System®, Edwards Lifesciences Corporation), the preferred type of valve prosthesis for a limited access approach. Patients will be randomized 1:1 to both arms with 80 patients per arm. Patients who are unwilling or unable to participate in the randomized study will be treated via conventional median sternotomy with a sutured aortic valve prosthesis and participate in a prospective registry.
Primary outcome is cardiac-specific quality of life, measured by two domains of the Kansas City Cardiomyopathy Questionnaire (KCCQ), up to one year after surgery. Secondary outcomes include, but are not limited to: generic quality of life measured with the Short Form-36 (SF-36), postoperative pain, perioperative outcome (i.e. technical success rate, operating time) and postoperative outcome (i.e. 30 day and one-year mortality, complication rate, hospital length of stay, reoperation rate and readmission rate). Questionnaires are administered face to face or by telephone prior to surgery and at one, three, six and twelve months after surgery. In the prospective registry the quality of life questionnaires and all clinical data from the patients will be collected and analyzed the exact same way as the data from patients included and randomized in the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Patients randomized to either the limited access or conventional aortic valve replacement will be blinded for the treatment until day four postoperatively. The patients participating in the prospective registry will not be blinded for their treatment.
All nurses on the postoperative ward are blinded for the treatment the patients received.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing an isolated biological aortic valve replacement for a severe and/or symptomatic aortic valve stenosis, defined as:
- •An aortic valve area of ≤1.0cm2, and;
- •Mean valve gradient ≥40mmHg, and/or;
- •A peak velocity of at least 4.0m/s.
- •Able to understand the nature of the study and what will be required of them;
- •All adult men and non-pregnant women;
- •BMI between 18-35.
排除标准
- •Inability to give written informed consent;
- •Inability to adequately answer the questionnaires;
- •Patients requiring additional cardiac surgery during the same procedure;
- •Patients requiring a reoperation;
- •(relative) contraindications for a limited access approach;
- •Undergoing an emergency operation;
- •Recent myocardial infarction (<90 days);
- •Recent stroke or transient ischemic attack (<6 months);
结局指标
主要结局
Changes in cardiac-specific quality of life after aortic valve replacement.
时间窗: One, three, six and twelve months after surgery
Change in cardiac specific quality of life after aortic valve replacement measured by the physical limitations and symptoms domains from the Kansas City Cardiomyopathy Questionnaire (KCCQ).
次要结局
- Clinical outcomes(Up to one year postoperatively.)
- Intensive Care length of stay(Up to one year postoperatively)
- Change is generic quality of life, assessed with the Mental Component Summary (MCS) of the Short Form-36 (SF-36).(One, three, six and twelve months after surgery)
- Perioperative outcomes(During surgery)
- Technicall success rate of the aortic valve replacement.(During surgery (peri-operatively))
- Effective orifice area of the aortic valve prosthesis(Up to one year postoperatively)
- Mean pressure gradient of the aortic valve prosthesis.(Up to one year postoperatively)
- Changes in quality of life domains of the Kansas City Cardiomyopathy Questionnaire (KCCQ)(One, three, six and twelve months after surgery)
- Change is generic quality of life, assessed with the Physical Component Summary (PCS) of the Short Form-36 (SF-36).(One, three, six and twelve months after surgery)
- Need of analgetic drugs(Up to one year postoperatively)
- Changes in the self-efficacy domain of the Kansas City Cardiomyopathy Questionnaire (KCCQ)(One, three, six and twelve months after surgery)
- Changes in social interference domain of the Kansas City Cardiomyopathy Questionnaire (KCCQ)(One, three, six and twelve months after surgery)
- Postoperative sternal pain(First seven days after surgery and one, three, six and twelve months after surgery)
- Hospital length of stay(Up to one year postoperatively)
研究者
Idserd Klop
Prinicpal Investigator
St. Antonius Hospital