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

January 28, 2019 updated by: Abbott Medical Devices
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100037
        • Fu Wai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: QuickOpt
QuickOpt is an optimization algorithm to program the AV, PV and VV delays
Device: QuickOpt
The QuickOpt algorithm will suggest values for programming AV, PV and VV delay.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Time required for each optimization method considered in this study
Time Frame: 1 day
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
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

February 4, 2009

First Submitted That Met QC Criteria

June 9, 2009

First Posted (Estimate)

June 11, 2009

Study Record Updates

Last Update Posted (Actual)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 28, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QuickOpt Study Asia

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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