NCT01519739

Brief Summary

The purpose of this study is to evaluate the safety and performance of the MediGuide™ system during CRT implants.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Jan 2012

Shorter than P25 for not_applicable heart-failure

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

January 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 27, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

October 30, 2019

Status Verified

October 1, 2019

Enrollment Period

4 months

First QC Date

January 18, 2012

Last Update Submit

October 28, 2019

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • The performance of the MediGuide™ system during CRT implant

    Performance will be assessed in terms occurence of adverse events, easy of use and potential benefits.

    1 month post CRT implant

Study Arms (1)

MediGuide Arm

EXPERIMENTAL
Device: MediGuide™

Interventions

MediGuide™DEVICE

MediGuide™ system will be used to guide CRT implants

MediGuide Arm

Eligibility Criteria

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

You may qualify if:

  • Meet clinical indication for implantation of an SJM CRT system according to the current European Society of Cardiology (ESC) Guidelines for cardiac and resynchronization therapy
  • Receiving a new implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement
  • Ability to provide informed consent for study participation and are willing and able to comply with the prescribed follow-up tests and schedule of evaluations

You may not qualify if:

  • Currently participating in any other clinical study
  • Have prosthetic valves
  • Are pregnant or planning pregnancy in the next 1 month
  • Are less than 18 years of age
  • Have ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Richter S, Doring M, Gaspar T, John S, Rolf S, Sommer P, Hindricks G, Piorkowski C. Cardiac resynchronization therapy device implantation using a new sensor-based navigation system: results from the first human use study. Circ Arrhythm Electrophysiol. 2013 Oct;6(5):917-23. doi: 10.1161/CIRCEP.113.000066. Epub 2013 Sep 3.

    PMID: 24002003DERIVED

Related Links

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Gerhard Hindricks, MD

    Herzzentrum Leipzig GmbH

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 18, 2012

First Posted

January 27, 2012

Study Start

January 1, 2012

Primary Completion

May 1, 2012

Study Completion

November 1, 2012

Last Updated

October 30, 2019

Record last verified: 2019-10