QuickOpt Chronic Study

Abbott

Status: Completed

Conditions: Heart Failure

Treatments: Device: Cardiac Resynchronization Therapy; Device: Optimization using echocardiography

Study type: Interventional

Funder types: Industry

Identifiers

NCT01172067

CR-09-063-AP-HF

Details and patient eligibility

About

The purpose of this study is to demonstrate that QuickOpt optimization can be as an alternative method for CRTP/D patients' optimization in clinical practice through the comparison of the improvement differences between the CRTP/D patients with different optimization at 12 months after implantation.The hypothesis is that the Heart Remolding parameter (LVESV) improvement of patients using QuickOpt parameters at 12 months after implant is not inferior (10%) to the patients by Echo optimization。

Full description

Clinical studies have demonstrated that the AVTI from QuickOptTM related significantly to the max aorta VTI (AVTI) by Echo, the concordance correlation coefficient (CCC) was so high from 0.96 to 0.99.

But up to now, there are no clinical trials to evaluate mid-long term clinical outcome for CRTP/D patients by QuickOptTM and Echo optimization, this is indeed the main purpose of the study; in addition, the clinical impact, the status of arrhythmia and agents of all the enrolled patients, will be evaluated at 1 year after implant.

Enrollment: 400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • Patient meets current CRT-P indications and be implanted with an SJM CRT-P device with V-V timing and a compatible lead system

  • Patient is able to provide written informed consent for study participation

Exclusion criteria

• • Patient has limited intrinsic atrial activity (≤ 40 bpm)

  • Patient has persistent or permanent AF
  • Patient has a 2o or 3o heart block
  • Patient's life expectancy is <12 months
  • Patient is <18 years old
  • Patient is pregnant
  • Patient is on IV inotropic agents
  • Patients who are ongoing other devices or agents study
  • Patients with heart transplanted or waiting for heart transplant
  • Patients with Hypertrophic and obstructive cardiomyopathy
  • Patients with severe aortic valve and mitral valve stenosis or regurgitation without replacement

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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400 participants in 2 patient groups

Quickopt Group

Experimental group

Description:

the QuickOpt Group patients will be optimized by QuickOpt(IEGM);

Treatment:

Device: Cardiac Resynchronization Therapy

Echocardiography group

Active Comparator group

Description:

the Echo Group patients will be optimized by Echo.

Treatment:

Device: Optimization using echocardiography