Effects of Post-Dilatation on THV Expansion, Hemodynamics, Durability, and Outcomes in Balloon-Expandable TAVI Prostheses
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- TAVI asymmetry index on freeze-frame fluoroscopic images
研究概览
简要总结
Asymmetrical and inadequate expansion of transcatheter heart valves (THVs) have been described as a key predictor of impaired valve hemodynamic performance predisposing patients for bioprosthetic valve dysfunction (BVD) and death. Post-dilatation using the original delivery system balloon at the identical filling volume after deployment of balloon-expandable THVs represents an invasive strategy to potentially optimize expansion and reduce asymmetry of balloon-expandable THVs. Currently, the efficacy and safety of routine post-dilatation has never been assessed in a randomized controlled fashion. The present randomized controlled DUOTAP trial aims to assess efficacy and safety of routine post-dilatation on THV expansion, hemodynamics, durability, and associated clinical outcomes in patients with severe aortic stenosis.
详细描述
This study is a randomized controlled trial investigating the effect of routine post-dilatation, using the original delivery balloon at nominal volume, in patients scheduled for and receiving a balloon-expandable THV at the Medical University of Vienna. Consecutive adult patients with severe degenerative AS scheduled for a balloon expandable THV will be prospectively enrolled at a university-affiliated tertiary center in Austria. Eligibility and decision for TAVI will be determined by a multidisciplinary Heart Team. All patients who are willing to participate will then be randomly assigned in a 1:1 ratio to undergo a) routine post-dilatation using the original delivery balloon at nominal volumes or b) no post-dilatation after THV deployment.
Methods:
The DUOTAP trial is an investigator-driven, prospective, single-blinded, randomized, controlled trial performed at the Medical University of Vienna. In patients assigned to the intervention group post-dilatation will be performed right after deployment of the THV. The balloon will be re-inserted into the deployed THV and after initiation of rapid ventricular pacing the balloon will be inflated at the level of the deployed TAVI prosthesis and then will be immediately deflated again. The duration of rapid ventricular pacing and additional balloon deployment is in the range of a few seconds.
Pre-specified study visits:
V0 (Pre-TAVI): Medical history and physical evaluation (concomitant diseases, risk factors, medication, EuroSCORE-II, height, weight, age, sex, blood pressure, heart rate, ECG, symptoms), Routine blood and urine analysis (serum creatinine, NT-proBNP, electrolytes, full blood count, etc.), Echocardiography, KCCQ overall score; V1 (TAVI): Fluoroscopic assessment of THV asymmetry, diameters and heights; V2 (Pre-discharge): Routine blood and urine analysis, Echocardiography; V3 (1 month Post-TAVI): Assessment of safety endpoints via phone follow-up; V4 (3 months Post-TAVI): Assessment of cross-sectional THV area on computed tomography (CT); V5 (1 year Post-TAVI): Medical history and physical evaluation (concomitant diseases, risk factors, medication, EuroSCORE-II, height, weight, age, sex, blood pressure, heart rate, ECG, symptoms), Routine blood and urine analysis (Serum creatinine, NT-proBNP, electrolytes, full blood count, etc.), Echocardiography, KCCQ overall score; V6 (5 years Post-TAVI): Medical history and physical evaluation (concomitant diseases, risk factors, medication, EuroSCORE-II, height, weight, age, sex, blood pressure, heart rate, ECG, symptoms), Routine blood and urine analysis (Serum creatinine, NT-proBNP, electrolytes, full blood count, etc.), Echocardiography, KCCQ overall score
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, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe AS
- •AS treatment by transfemoral TAVI as determined by an interdisciplinary heart team board
- •Anatomical feasibility to receive a balloon-expandable THV
- •Age 65 years or older
- •Informed consent
排除标准
- •Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., non compliant, perforated)
- •Bicuspid aortic valve anatomy
- •Valve-in-valve procedure
- •Severe calcification of the aortic annulus protruding into the left ventricular outflow tract and predisposing for annular rupture
- •Significant stenosis of the left main or proximal left anterior descending artery with substantial risk of hemodynamic instability during rapid ventricular pacing
研究组 & 干预措施
No post-dilatation after THV deployment
Nominal post-dilatation using the original delivery balloon
干预措施: Post-dilatation (Other)
结局指标
主要结局
TAVI asymmetry index on freeze-frame fluoroscopic images
时间窗: Peri-procedural
The TAVI asymmetry will be calculated as: longer THV height/shorter THV height) - 1\] × 100. The TAVI asymmetry index: Minimum value: 0 Maximum value: NA Higher values indicate more asymmetry.
次要结局
- Hypo-attenuated leaflet thickening(Three months)
- Major periprocedural complications(At 2 weeks post THV-Implantation)
- Cross-sectional area of implanted THV on CT scans(At 3 months post THV-Implantation)
- Mean residual trans-prosthetic gradient(At year 1 and year 5 post THV-Implantation)
- Prevalence of bioprosthetic valve degeneration according to the Aortic Valve Academic Research Consortium criteria(At year 1 and year 5 post THV-Implantation)
- All-cause mortality(At year 1 and year 5 post THV-Implantation)
- Cumulative frequency of CV-related hospitalizations(At year 1 and year 5 post THV-Implantation)
研究者
Christian Nitsche
MD, PhD
Medical University of Vienna