QuickOpt Chronic Study

NCT01172067 | Completed Results DMC

• 1 other identifier: CR-09-063-AP-HF
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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。

Conditions

Heart Failure

Keywords

CRT; heart failure; optimization; Timing cycle optimization methods

Outcome Measures

Primary Outcomes (1)

• Percent Change in Left Ventricular End Systolic Volume (LVESV) at 12 Months Compared to Baseline

  The primary outcome is the percent change in LVESV at 12 months compared to baseline. This outcome measure is assessed through evaluation of echocardiograms at both baseline and 12 months, with a decrease in the percent change in LVESV at 12 months indicating clinical improvement. The percent change in patients with devices optimized with QuickOpt is compared with that of patients with devices optimized using standard echocardiography techniques to determine if one method of optimization results in a greater change in LVESV.

  Baseline and12 months

Study Arms (2)

Quickopt Group

EXPERIMENTAL

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

Device: Cardiac Resynchronization Therapy

Echocardiography group

ACTIVE COMPARATOR

the Echo Group patients will be optimized by Echo.

Device: Optimization using echocardiography

Interventions

Cardiac Resynchronization Therapy 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.

Quickopt Group

Optimization using echocardiography DEVICE

Optimization of the AV/PV and VV delays using echocardiography

Echocardiography group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Results Point of Contact

• Title: Clay Cohorn, Program Director
• Organization: CRT, Global Clinical Affairs, Cardiac Arrhythmias and Heart Failure, Abbott Medical Devices

clay.cohorn@abbott.com

+1 972 309 8087

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2010
• First Posted: July 29, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: October 8, 2019
• Results First Posted: September 30, 2019

Record last verified: 2019-09

Locations

CN (1)