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QuickOptTM Study - Using the QuickOptTM Method for Timing Cycle Optimization (QuickOpt)

Primary Purpose

Heart Failure

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

QuickOpt

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring CRT, heart failure, optimization, Timing cycle optimization methods

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 is unable to provide analyzable echocardiogram images
Patient's life expectancy is <12 months
Patient is <18 years old
Patient is pregnant
Patient is on IV inotropic agents

Sites / Locations

Fu Wai Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

QuickOpt

Arm Description

QuickOpt is an optimization algorithm to program the AV, PV and VV delays

Outcomes

Primary Outcome Measures

To compare the aortic velocity time integral value derived by the QuickOptTM optimization method with that derived by the standard echocardiography optimization methods

Secondary Outcome Measures

Time required for each optimization method considered in this study

Effects of any spontaneous cardiac events during the QuickOpt optimization process and these events are not limited to premature ventricular complex (PVC), pacemaker-mediated tachycardia (PMT), atrial fibrillation (AF) and far-field R-wave oversensing

Full Information

NCT ID

NCT00918294

First Posted

February 4, 2009

Last Updated

January 28, 2019

Sponsor

Abbott Medical Devices

1. Study Identification

Unique Protocol Identification Number

NCT00918294

Brief Title

QuickOptTM Study - Using the QuickOptTM Method for Timing Cycle Optimization

Acronym

QuickOpt

Official Title

QuickOptTM Study - Using the QuickOptTM Method for Timing Cycle Optimization

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abbott Medical Devices

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

QuickOptTM optimization method provides a quicker, simpler and reliable alternative to standard echocardiography methods for optimization of sensed AV, paced AV and V-V delays in patients with CRT-P devices

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

Keywords

CRT, heart failure, optimization, Timing cycle optimization methods

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

QuickOpt

Arm Type

Experimental

Arm Description

QuickOpt is an optimization algorithm to program the AV, PV and VV delays

Intervention Type

Device

Intervention Name(s)

QuickOpt

Intervention Description

The QuickOpt algorithm will suggest values for programming AV, PV and VV delay.

Primary Outcome Measure Information:

Title

To compare the aortic velocity time integral value derived by the QuickOptTM optimization method with that derived by the standard echocardiography optimization methods

Time Frame

1 day

Secondary Outcome Measure Information:

Title

Time required for each optimization method considered in this study

Time Frame

1 day

Title

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 is unable to provide analyzable echocardiogram images Patient's life expectancy is <12 months Patient is <18 years old Patient is pregnant Patient is on IV inotropic agents

Facility Information:

Facility Name

Fu Wai Hospital

City

Beijing

ZIP/Postal Code

100037

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

22490397

Citation

Hua W, Wang DM, Cai L, Sun CF, Fu GS, Wang YT, Yan J, Luo ZL, Xu J, Wang ZY, Xu G, Shen FR, Xu W, Wang JF, Ren XJ, Jin W, Zhang N, Lau EO, Zhang S. A prospective study to evaluate the efficacy of an intracardiac electrogram-based atrioventricular and interventricular intervals optimization method in cardiac resynchronization therapy. Chin Med J (Engl). 2012 Feb;125(3):428-33.

Results Reference

derived

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QuickOptTM Study - Using the QuickOptTM Method for Timing Cycle Optimization

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