Cardiac Resynchronization Therapy (CRT) Efficacy Study

January 29, 2018 updated by: Medtronic Bakken Research Center
The aim of this research study is the invasive evaluation of CR therapy efficacy in patients treated with an InSync Sentry device using an external monitoring device to obtain important cardiac parameters.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

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

  • Germany
      • Berlin, Germany, 13353
        • Deutsches Herzzentrum Berlin

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 indicated for InSync Sentry CRT device implant
  • The patient must be willing and capable of following the study protocol
  • EF ≤ 40%
  • Systolic pulmonary artery pressure derived by echocardiography > 40
  • Patients with their device functioning in a bi-ventricular mode, with defibrillation detection and therapy enabled
  • Marked released transvenous RVCoil lead

Exclusion Criteria:

  • Patients with chronic AF
  • Patients with unipolar atrial or unipolar right ventricular leads
  • Patients needing a Lower Rate faster than 110 beats per minute
  • Patients with an implanted Medtronic Sentry in whom missing one day's fluid-measurement value is undesirable
  • Patients who cannot tolerate turning off Rate Response during the study
  • Patients with acute ischemia
  • Patients whose InSync Sentry battery is at ERI or EOL status
  • Patients with "RAMware" downloaded from other studies
  • Patients with medical conditions that would limit study participation
  • Patients who are pregnant
  • Patients enrolled in another study, which could influence the result of this study
  • Patients on the heart transplantation list or patients with transplanted hearts
  • Patients is not available for follow-up care
  • Patients has not signed a consent form
  • Patients with renal failure needing dialysis
  • Patients whose compliance can expected to be poor
  • Patients with a mechanical tricuspid valve
  • Life expectation < 12 months
  • Severe PAOD (peripheral arterial occlusive disease)
  • Underage patients, pregnant or breast feeding women and female patients not using adequate contraception are excluded from participating in the study

Since right after implantation study procedure will follow, patient has to sign the informed consent before the implantation. However the following criteria are device based and can therefore not checked at time of sign off.

Therefore lead performance will be checked right after the implant and before the study specific procedure. If exclusion criteria are fulfilled patient exit the study and no study specific procedure will be done.

  • Patients with non-intact or unstable leads, as indicated on the "Quick Look" screen of the Medtronic Model 2090 programmer by the presence of lead warnings such as the following:

    • LV pacing lead impedance is > 2500 ohms
    • LV pacing lead impedance is < 200 ohms
    • A. pacing lead impedance is > 2500 ohms
    • A. pacing lead impedance is < 200 ohms
    • SVC defib lead impedance is > 200 ohms
    • SVC defib lead impedance is < 20 ohms
    • RV pacing lead impedance is > 2500 ohms
    • RV pacing lead impedance is < 200 ohms
  • Patients with atrial pacing thresholds lower than 1.0 volts at .03 ms
  • Patients with right ventricular pacing thresholds lower than 1.0 volts at .03 ms
  • Patients with left ventricular pacing thresholds lower than 1.0 volts at .03 ms
  • Patients in whom a Lower Rate cannot be programmed to achieve consistent atrial pacing for the duration of download software installed

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Device: CRT
classified

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
classified
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Medtronic Bakken Research Center

Collaborators

Medtronic

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

December 1, 2008

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

January 13, 2009

First Submitted That Met QC Criteria

January 13, 2009

First Posted (Estimate)

January 14, 2009

Study Record Updates

Last Update Posted (Actual)

January 30, 2018

Last Update Submitted That Met QC Criteria

January 29, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEN_G_CA_11

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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