Device-based QRS Evaluation

January 31, 2019 updated by: Abbott Medical Devices
The purpose of this study is to collect simultaneous surface electrocardiogram (ECG) recordings and Cardiac Resynchronization Therapy (CRT) intracardiac electrogram (IEGM) recordings of variations in electrical synchrony.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

103

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

  • Italy
    • MI
      • San Donato Milanese, MI, Italy, 20097
        • I.R.C.C.S. Policlinico San Donato

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

Sampling Method

Non-Probability Sample

Study Population

The study will include approximately 100 patients who have been implanted with SJM Quadripolar Pacing Systems

Description

Inclusion Criteria:

  • Already implanted with SJM Quadripolar CRT Pacing System
  • Ability to provide informed consent for study participation
  • Willing to comply with the study evaluation requirements
  • At least 18 years of age

Exclusion Criteria:

  • Resting ventricular rate >100 bpm
  • Intrinsic PR interval > 300 ms
  • Paroxysmal or persistent atrial tachycardia or atrial fibrillation documented
  • Pregnant or plans to become pregnant during the study

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ECG+IEGM
Surface ECG and intracardiac electrogram recordings will be taken during the adjustment of programmable Cardiac Resynchronization Therapy settings
Device: ECG+IEGM
Cardiac Resynchronization Therapy programming adjustments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Characterize CRT IEGM-based estimations of QRS duration
Time Frame: Acute (1 day)
Acute (1 day)

Collaborators and Investigators

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

Sponsor

Abbott Medical Devices

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 (Actual)

June 1, 2016

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

June 22, 2016

First Submitted That Met QC Criteria

June 22, 2016

First Posted (Estimate)

June 27, 2016

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRD_865

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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