NCT01362465

Brief Summary

This study is an effort to use left ventricular (LV) lead based measurements to identify late electrical activation and avoid scar.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P50-P75 for early_phase_1 heart-failure

Timeline
Completed

Started Jun 2011

Shorter than P25 for early_phase_1 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

First Submitted

Initial submission to the registry

May 25, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 30, 2011

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

September 20, 2012

Status Verified

September 1, 2012

Enrollment Period

10 months

First QC Date

May 25, 2011

Last Update Submit

September 18, 2012

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Measure how RV to LV conduction times are altered by pacing site in patients with a CRT system.

    This procedure will take approximately 30 minutes prior to implant of a CRT system. At completion of this study the patient is not followed and will be transferred to another study if enrolled in a clinical or followed as a routine implant by the center.

    30 minutes

Study Arms (1)

Cardiac Resynchronization Therapy (CRT)

EXPERIMENTAL

Implanting device to measure delays between paced chambers in heart failure patients.

Procedure: Cardiac Resynchronization Therapy

Interventions

Cardiac Resynchronization TherapyPROCEDURE

Implanting device to measure delays between paced chambers in heart failure patients.

Also known as: CRT
Cardiac Resynchronization Therapy (CRT)

Eligibility Criteria

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

You may qualify if:

  • Patient is greater than 18 years of age.
  • The patient or the patient's legally authorized representative is willing to give informed consent.
  • CRT indicated guidelines.
  • Patient is receiving a Medtronic IPG or ICD.

You may not qualify if:

  • Patients who are pregnant.
  • Patient is in AF.
  • Patient with 3rd degree AV block.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, ArtificialElectric Stimulation TherapyTherapeutics

Study Officials

  • Brett Atwater, MD

    Durham VA

    PRINCIPAL INVESTIGATOR

  • Robert Hoyt, MD

    Catholic Health Initiative Iowa Corp

    PRINCIPAL INVESTIGATOR

  • Eric E Johnson, MD

    Sterns Cardiovascular Foundation

    PRINCIPAL INVESTIGATOR

  • John F Beshai, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2011

First Posted

May 30, 2011

Study Start

June 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

September 20, 2012

Record last verified: 2012-09