跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NCT07309029
NCT07309029招募中不适用

PROspective Evaluation of Pre-empTive Left Atrial Venoarterial Extra-Corporeal Membrane oxygenaTion for Complex High-risk Transcatheter Aortic Valve Replacement: PROTECT-TAVR

Atlantic Health System2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年1月1日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Primary Efficacy Endpoint: Composite of in-hospital death, intraprocedural resuscitated cardiac arrest or emergent cardiac surgery.
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The goal of this clinical trial is to evaluate the feasibility, effectiveness, and safety of pre-emptive left atrial veno-arterial extracorporeal membrane oxygenation (LAVA-ECMO) in patients undergoing complex and high-risk transcatheter aortic valve replacement (TAVR). These patients include adults with severe aortic stenosis who are hemodynamically unstable or at risk of instability due to anatomical complexity. The main questions it aims to answer are:

  1. Does pre-emptive LAVA-ECMO reduce the incidence of in-hospital death, intraprocedural cardiac arrest, or emergent cardiac surgery?
  2. What are the safety outcomes related to LAVA-ECMO, including major vascular, bleeding, or cardiac structural complications? -This is a single-arm, prospective, multi-center study with no comparison group.

Participants will:

  • Be screened for eligibility based on hemodynamic status and anatomical complexity
  • Undergo pre-emptive LAVA-ECMO cannulation prior to or during TAVR
  • Receive follow-up assessments at 30 days and 1 year, including clinical evaluation and echocardiography

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 100 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •- Patients are required to have either a Class III hemodynamic status OR type B or type C anatomical complexity with Class II (at risk) hemodynamics (Figure 2).
  • •Hemodynamic Criteria
  • •Major Criteria (Class III)
  • •Systolic blood pressure <90 mmHg or MAP<60 mmHg
  • •Need for vasopressors or inotropes to maintain MAP>60 mmHg
  • •Evidence of end-organ damage including: acute kidney injury, liver dysfunction, elevated lactate or altered mentation
  • •Minor Criteria (Class II)
  • •Left ventricular ejection fraction <35%
  • •Pulmonary hypertension (pulmonary artery systolic pressure >60 mmHg) with right ventricular dysfunction
  • •Pulmonary capillary wedge pressure >30 mmHg
  • •Anatomic criteria
  • •Major Criteria (Type C)
  • •Native or valve-in-valve TAVR requiring single-leaflet modification for a large area of myocardium at risk (e.g. patients with large or dominant left circulation)
  • •Native or valve-in-valve TAVR requiring dual-leaflet modification
  • •Severe bioprosthetic aortic regurgitation
  • •Severe 3-vessel coronary artery disease not amenable to revascularization (SYNTAX score >33)
  • •Minor Criteria (Type B)
  • •Native or valve-in-valve TAVR requiring single-leaflet modification
  • •Severe commissural misalignment requiring leaflet modification
  • •High-risk for coronary occlusion not amenable to leaflet modification
  • •Critical low-flow low-gradient aortic stenosis (defined as an estimated aortic valve area ≤0.5 cm2)

排除标准

  • •Age <18 or pregnant
  • •General absolute contraindications to TAVR
  • •Severe peripheral artery disease with infeasibility for veno-arterial extracorporeal membrane oxygenation implantation.
  • •Contraindications to transeptal cannulation (e.g. pre-existing interatrial septum occluder device).
  • •Pre-existing Impella treatment.
  • •Onset of shock >12 hours.
  • •Preceding cardiac arrest with prolonged resuscitation (>40 minutes).
  • •Other severe concomitant disease with life expectancy <6 months.
  • •Participation in another trial with an intervention.
  • •Any class I hemodynamic status
  • •Type A anatomical complexity with class I or II hemodynamic status

结局指标

主要结局

Primary Efficacy Endpoint: Composite of in-hospital death, intraprocedural resuscitated cardiac arrest or emergent cardiac surgery.

时间窗: From enrollment through hospital discharge (up to 30 days post-procedure)

次要结局

  • Primary Safety Endpoint: Composite of VARC-3 major vascular complications, type 3 or 4 VARC-3 bleeding complications or major cardiac structural complications related to left atrial cannulation.(From enrollment through hospital discharge (up to 30 days post-procedure))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gennaro Giustino

MD

Atlantic Health System

研究点 (2)

Loading locations...

相似试验

招募中
4 期
Waiting on Atrial fibrillation Intervention Therapy (WAIT) StudyAtrial fibrillation
2025-524182-25-00Karolinska University Hospital200
招募中
4 期
Evaluation of Two Different Regimens of the Antiarrhythmic Drug Amiodarone to Maintain Normal Sinus Rhythm After Electrical Cardioversion in Patients With Persistent Atrial FibrillationPersistent Atrial Fibrillation
NCT07273994Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau312
已完成
不适用
Posterior Pericardiotomy for Prevention of POAF After Cardiac Surgery: RCT in YemenCardiac Tamponade
NCT07266935Taiz University - Faculty of Medicine210
招募中
4 期
Waiting on Atrial Fibrillation Intervention Therapy (WAIT) Study
NCT07275697Emma Svennberg200
尚未招募
不适用
LUMENS-1 Canada Early Feasibility Study Clinical Investigation PlanBrain Aneurysm
NCT07259018LuSeed Vascular LTD.10