NCT00822146

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Dec 2008

Longer than P75 for not_applicable heart-failure

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

December 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

July 3, 2025

Status Verified

January 1, 2018

Enrollment Period

3 years

First QC Date

January 13, 2009

Last Update Submit

June 30, 2025

Conditions

Heart Failure

Keywords

CRT

Outcome Measures

Primary Outcomes (1)

  • classified

    12 months

Study Arms (1)

1

EXPERIMENTAL
Device: CRT

Interventions

CRTDEVICE

classified

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deutsches Herzzentrum Berlin

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

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

Study Record Dates

First Submitted

January 13, 2009

First Posted

January 14, 2009

Study Start

December 1, 2008

Primary Completion

December 1, 2011

Study Completion

March 1, 2013

Last Updated

July 3, 2025

Record last verified: 2018-01

Locations

DE(1)