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Cardiac Resynchronization Therapy (CRT) Efficacy Study

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
CRT
Sponsored by
Medtronic Bakken Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure focused on measuring CRT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Deutsches Herzzentrum Berlin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

classified

Secondary Outcome Measures

Full Information

First Posted
January 13, 2009
Last Updated
January 29, 2018
Sponsor
Medtronic Bakken Research Center
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT00822146
Brief Title
Cardiac Resynchronization Therapy (CRT) Efficacy Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Bakken Research Center
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
CRT

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
CRT
Intervention Description
classified
Primary Outcome Measure Information:
Title
classified
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Deutsches Herzzentrum Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany

12. IPD Sharing Statement

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Cardiac Resynchronization Therapy (CRT) Efficacy Study

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