NCT00918294

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2009

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 11, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

2 years

First QC Date

February 4, 2009

Last Update Submit

January 28, 2019

Conditions

Keywords

CRTheart failureoptimizationTiming cycle optimization methods

Outcome Measures

Primary Outcomes (1)

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

    1 day

Secondary Outcomes (2)

  • Time required for each optimization method considered in this study

    1 day

  • 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

    1 day

Study Arms (1)

QuickOpt

EXPERIMENTAL

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

Device: QuickOpt

Interventions

QuickOptDEVICE

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

QuickOpt

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fu Wai Hospital

Beijing, 100037, China

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2009

First Posted

June 11, 2009

Study Start

September 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

January 30, 2019

Record last verified: 2019-01

Locations