NCT00632450

Brief Summary

The EnSite Real-Time Cardiac Performance Measurements Study (EnSite RT CPM) is a multicenter, international, acute, non-significant risk study, designed to enroll a maximum of 40 patient. The goal of the study is to collect 3-D systolic/diastolic data with the EnSite NavX Mapping system during a CRT implant. Patients enrolled in this study will undergo NavX CPM recording of the heart using the EnSite NavX Mapping system during the implantation of a cardiac resynchronization therapy device.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2007

Shorter than P25 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

December 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 29, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 10, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

10 months

First QC Date

February 29, 2008

Last Update Submit

February 1, 2019

Conditions

Heart Failure

Study Arms (1)

1

Eligibility Criteria

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

Patients indicated for implantation of a CRT pulse generator

You may qualify if:

  • Be undergoing a new St. Jude Medical CRT-D or CRT-P device implantation
  • Have the ability to provide informed consent for study participation and be willing to comply with the prescribed perioperative evaluations

You may not qualify if:

  • Have a recent myocardial infarction within 40 days prior to enrollment
  • Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures
  • Be less than 18 years of age
  • Be pregnant women
  • Be currently participating in a clinical study that includes an active treatment arm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Jude Medical

Sunnyvale, California, 94086, United States

Location

Related Publications (1)

  • Sperzel J, Brandt R, Hou W, Doelger A, Zdarek J, Rosenberg SP, Ryu K, Koh S, Yang M. Intraoperative characterization of interventricular mechanical dyssynchrony using electroanatomic mapping system--a feasibility study. J Interv Card Electrophysiol. 2012 Nov;35(2):189-96. doi: 10.1007/s10840-012-9695-0. Epub 2012 Jun 14.

    PMID: 22695763DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Johannes Sperzel, MD

    Kerckhoff Klinik GmbH

    PRINCIPAL INVESTIGATOR

  • Andre d'Avila, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

  • Imran Niazi, MD

    Arrhythmia Center of Southern Wisconsin, Ltd

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 29, 2008

First Posted

March 10, 2008

Study Start

December 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

February 5, 2019

Record last verified: 2019-02

Locations

US(1)