NCT01466621

Brief Summary

The present proposal is designed to investigate the response to CRT in patients who were previously paced from the right ventricle (RV). The negative physiologic and structural changes associated with chronic RV pacing are well documented, but patient response following upgrade to CRT after chronic RV pacing has not been well characterized in a large cohort.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
743

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2011

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

October 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 2, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 8, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

February 24, 2016

Status Verified

February 1, 2016

Enrollment Period

2.7 years

First QC Date

November 2, 2011

Last Update Submit

February 23, 2016

Conditions

Heart FailurePacing Induced Dyssynchrony

Keywords

cardiac resynchronization therapyheart failuremortality

Outcome Measures

Primary Outcomes (2)

  • Death from any cause

    Retrospectively measure the time in days from device implant to death, if applicable.

    Average of 4 years

  • Cardiovascular Hospitalization

    Retrospectively measure the time in days from device implant to hospitalization, if applicable.

    Average of 4 years

Secondary Outcomes (1)

  • Change in ejection fraction

    Approximately one year

Study Arms (2)

Previously RV Paced

Patients who were RV paced prior to receiving a cardiac resynchronization therapy device.

Non-Previously RV Paced

Patients who received a CRT device without being previously RV paced.

Eligibility Criteria

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

A retrospective review of patients receiving CRT at United Heart \& Vascular Clinic between 2003 and 2009.

You may qualify if:

  • Received a CRT device between 2003 and 2009 at United Heart \& Vascular Clinic
  • QRS duration \> 120 msec
  • Pre-CRT ejection fraction =\< 35%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

United Heart & Vascular Clinic

Saint Paul, Minnesota, 55102, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Alan J Bank, MD

    United Heart & Vascular Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2011

First Posted

November 8, 2011

Study Start

October 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

February 24, 2016

Record last verified: 2016-02

Locations

US(1)