NCT01060449

Brief Summary

Cardiac resynchronization therapy (CRT) is a device implanted to improve the function of some people's hearts. CRT involves the placement of 3 wires in the heart through a vein near the front of your left or right shoulder into three pumping chambers of the heart, the most important being the left lower chamber, left ventricle (LV).

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 not_applicable

Timeline
Completed

Started Aug 2008

Longer than P75 for not_applicable

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

August 1, 2008

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 2, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

December 17, 2013

Status Verified

December 1, 2013

Enrollment Period

2.8 years

First QC Date

January 29, 2010

Last Update Submit

December 15, 2013

Conditions

Congestive Heart Failure

Keywords

cardiac resynchronization therapycongestive heart failure

Outcome Measures

Primary Outcomes (1)

  • Ejection Fraction

    6 months

Secondary Outcomes (3)

  • Quality of Life

    6 months

  • Six minute hall walk

    6 months

  • End diastolic dimension

    6 months

Study Arms (2)

LV lead low output

OTHER

Low output on left ventricular pacing lead. Intervention: LV stimulus intensity

Other: LV stimulus intensity

LV lead high output

OTHER

High output on left ventricular lead Intervention: LV stimulus intensity

Other: LV stimulus intensity

Interventions

LV stimulus intensityOTHER

The voltage and pulse duration used for programmed LV pacing Arm 1: LV lead low output Arm 2: LV lead high output

LV lead high outputLV lead low output

Eligibility Criteria

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

You may qualify if:

  • Adults who fulfill approved criteria to receive a cardiac resynchronization device.

You may not qualify if:

  • Adults who are unable to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

  • Bavikati VV, Langberg JJ, Williams BR 3rd, Kella D, Lloyd MS. Stimulus intensity in left ventricular leads and response to cardiac resynchronization therapy. J Am Heart Assoc. 2012 Oct;1(5):e000950. doi: 10.1161/JAHA.112.000950. Epub 2012 Oct 25.

    PMID: 23316285RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Michael S. Lloyd, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 29, 2010

First Posted

February 2, 2010

Study Start

August 1, 2008

Primary Completion

June 1, 2011

Study Completion

February 1, 2012

Last Updated

December 17, 2013

Record last verified: 2013-12

Locations

US(1)