跳至主要内容
临床试验/NCT00489177
NCT00489177已完成4 期

Optimal Programming to Improve Mechanical Indices, Symptoms and Exercise in Cardiac Resynchronization Therapy.

University of Calgary1 个研究点 分布在 1 个国家目标入组 461 人开始时间: 2007年6月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
461
试验地点
1
主要终点
Clinical benefit (reduction in SAS of at least 1 class or a 25% or larger improvement in 6 minute hall walk distance) plus structural remodeling (15% or greater reduction in left LV end systolic volume or ≥ 5% absolute improvement in echo-derived LV EF)

研究概览

简要总结

This international study is assessing if repeat adjustment of the timing between the three leads in a cardiac resynchronization therapy (CRT) defibrillator will increase the likelihood of benefit (symptoms and heart function) compared to usual device programming. The hypothesis is that QuickOpt facilitated serial optimization of sensed atrioventricular (sAV), paced atrioventricular (pAV), and inter-ventricular (VV) timing in the initial 9 months following successful CRT will increase the rate of clinical response and structural remodeling at 12 months compared to usual care.

详细描述

Cardiac resynchronization therapy (CRT) is primarily designed to synchronize the mechanical activity of the heart. While CRT is beneficial in average, a sizable proportion of patients do not clearly benefit from (respond to) CRT. Whether routinely optimizing the timing between the atria and ventricles (AV timing) and the timing between the left and right ventricles (VV timing) will significantly increase the likelihood of patients benefiting from (responding to) CRT is unknown.

The combination of simple and reliable measures of functional capacity (specific activity score [SAS] and 6-minute walk distance) with echocardiographic measures of left ventricular (LV) volume and ejection fraction (EF) is a practical way of defining response to CRT.

Based on surveys, most patients receiving CRT devices do not have formal optimization of AV and VV timing. This is largely because the usefulness of this is questionable and significant resources are required to perform detailed echo measurements.

A method for estimating optimal sensed AV (sAV), paced AV (pAV), and VV timing using intra-cardiac electrograms (I-EGM) has been developed (QuickOptTM) and offers a quick, simple and inexpensive means to optimize both CRT timing. However, the utility of QuickOptTM optimization is unproven.

Primary hypothesis. QuickOpt facilitated serial optimization of sAV, pAV, and VV timing in the initial 9 months following successful CRT will increase the rate of clinical response and structural remodeling at 12 months compared to usual care. Clinical response will be defined as a reduction in SAS of > 1 class or a 25% or larger improvement in 6 minute hall walk distance at 12 months versus baseline. Structural remodeling will be defined as a 15% or greater reduction in left LV end systolic volume or ≥ 5% absolute improvement in echo-derived LV EF at 12 months versus baseline.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • CRT-D indications and be implanted with an SJM CRT-D device with VV timing and a compatible lead system.
  • Able to complete a 6-minute hall walk with the only limiting factor to be fatigue or shortness of breath.
  • Geographically stable and willing to comply with follow-up.
  • Adequate echocardiographic images to measure LV end systolic volume.

排除标准

  • Epicardial ventricular lead system.
  • Ability to walk ≥ 450 meters in 6 minutes
  • Limited intrinsic atrial activity (≤ 40 bpm).
  • Persistent or permanent AF.
  • 2° or 3° heart block.
  • Life expectancy is less than 1 year.
  • Patient is pregnant.
  • Receiving IV inotropic agents.

研究组 & 干预措施

A

Active Comparator

QuickOpt

干预措施: A (Device)

B

Placebo Comparator

Usual care

干预措施: B (Device)

结局指标

主要结局

Clinical benefit (reduction in SAS of at least 1 class or a 25% or larger improvement in 6 minute hall walk distance) plus structural remodeling (15% or greater reduction in left LV end systolic volume or ≥ 5% absolute improvement in echo-derived LV EF)

时间窗: 12 months

次要结局

  • Rate of late (12-month) versus early (3 month) response to CRT(3 and 12 months)
  • Changes in BNP(3 and 12 months)
  • Inter-/intra-ventricular dysynchrony(3 and 12 months)

研究者

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

Dr. Derek Exner

Professor

University of Calgary

研究点 (1)

Loading locations...

相似试验