NCT00399412

Brief Summary

The purpose of this study is to collect surface electrograms from standard and several non-standard configurations in patients with long QT syndrome, heart failure, cardiac resynchronization therapy or wide QRS during a routine outpatient assessment. The ECGs collected will be used as test signals by the sponsor for the development of a subcutaneous implantable defibrillator

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2006

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 14, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

February 16, 2017

Status Verified

October 1, 2009

Enrollment Period

1.1 years

First QC Date

November 10, 2006

Last Update Submit

February 14, 2017

Conditions

Long QT SyndromeWide QRS ComplexesHeart FailureCardiac Resynchronisation

Keywords

S-ICDICDECG signalsResting

Study Arms (4)

LQTS

Long QT syndrome

Device: subcutaneous ICD

HF

Heart Failure

Device: subcutaneous ICD

CRT

Cardiac Resynchronization Therapy

Device: subcutaneous ICD

Wide QRS

QRS \> 120 milliseconds

Device: subcutaneous ICD

Interventions

subcutaneous ICDDEVICE
CRTHFLQTSWide QRS

Eligibility Criteria

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

Patients with long QT syndrome, heart failure, cardiac resynchronization therapy or wide QRS.

You may qualify if:

  • Patients attending the outpatient for routine follow-up for their cardiac disease or to have an implanted device follow-up

You may not qualify if:

  • Patients unable or unwilling to provide informed consent
  • Any condition which precludes the subject's ability to comply with the study requirements, including completion of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Papworth Hospital NHS Trust

Papworth Everard, Cambridge, CB3 8RE, United Kingdom

Location

MeSH Terms

Conditions

Long QT SyndromeHeart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseaseHeart Defects, CongenitalCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Andrew A Grace, MD PhD

    Papworth Hospital NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 10, 2006

First Posted

November 14, 2006

Study Start

November 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

February 16, 2017

Record last verified: 2009-10

Locations

GB(1)