QuickOpt Chronic Study

NCT ID: NCT01172067

Last Updated: 2019-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2016-01-31

Brief Summary

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。

Detailed 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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Quickopt Group

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

Group Type: EXPERIMENTAL

Cardiac Resynchronization Therapy

Intervention Type: DEVICE

Patients will be optimized using QuickOpt (IEGM) algorithm installed on the Merlin device programmer within 2 weeks and 3 and 6 months after device implantation.

Echocardiography group

the Echo Group patients will be optimized by Echo.

Group Type: ACTIVE_COMPARATOR

Optimization using echocardiography

Intervention Type: DEVICE

Optimization of the AV/PV and VV delays using echocardiography

Interventions

Cardiac Resynchronization Therapy

Patients will be optimized using QuickOpt (IEGM) algorithm installed on the Merlin device programmer within 2 weeks and 3 and 6 months after device implantation.

Intervention Type: DEVICE

Optimization using echocardiography

Optimization of the AV/PV and VV delays using echocardiography

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fuwai Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

CR-09-063-AP-HF

Identifier Type: -

Identifier Source: org_study_id