NCT01233323

Brief Summary

The purpose of this study is to collect sensor data from patients with implanted cardiac resynchronization devices who exhibit phrenic nerve stimulation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2010

Typical duration for all trials

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

February 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

February 3, 2017

Status Verified

February 1, 2017

Enrollment Period

2.1 years

First QC Date

November 2, 2010

Last Update Submit

February 2, 2017

Conditions

Heart Failure

Keywords

Phrenic nerve stimulationCardiac Resynchronization TherapyHeart FailureHeart Diseases

Outcome Measures

Primary Outcomes (1)

  • Data collection

    Collect sensor data in patients with implanted CRT-D devices who exhibit phrenic nerve stimulation.

    3 months follow up

Study Arms (1)

All study patients (single arm study)

All eligible patients will be included in the only study arm and will undergo study testing.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients implanted with a COGNIS™ CRT-D device

You may qualify if:

  • Willing and capable of providing informed consent and of participating in all testing
  • Age 18 or above or of legal age to give informed consent specific to national law
  • Implanted with a Boston Scientific COGNIS™ family device
  • Geographically stable and is available for follow-up procedures at a study centre

You may not qualify if:

  • Patients that are pacemaker-dependent
  • Women who are pregnant or plan to become pregnant during the study (method of assessment upon physician's discretion)
  • Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry
  • Patients who are not expected to support approximately 30 minutes of study testing procedures
  • Patients who are not mentally competent enough to provide feedback on PS during study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deutsches Herzzentrum Berlin

Berlin, Germany

Location

MeSH Terms

Conditions

Heart FailureHeart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Michael Glikson, MD

    Heart Institute, Sheba Medical Center, Tel Hashomer, Israël

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2010

First Posted

November 3, 2010

Study Start

February 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

February 3, 2017

Record last verified: 2017-02

Locations

DE(1)