NCT01169246

Brief Summary

Primary objective is to assess the efficacy of the new ATP Autoswitch function in simple, dual or triple chamber ICD.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1,254

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

November 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 26, 2010

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

March 25, 2019

Status Verified

February 1, 2015

Enrollment Period

5.3 years

First QC Date

July 22, 2010

Last Update Submit

March 21, 2019

Conditions

Ventricular Arrythmias

Keywords

ATP,CRT, ICD PARADYM

Outcome Measures

Primary Outcomes (1)

  • Ventricular Tachyarrhythmia episode

    % of VT episode successfully reduced by the ATP Auto-switch

    2 years

Secondary Outcomes (1)

  • Arrhythmia incidence

    2 years

Study Arms (1)

Paradym VR, DR and CRT models

Eligibility Criteria

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

ICD/CRT-D implanted patients population

You may qualify if:

  • The patient has been implanted (primo implantation or replacement) with an ICD model PARADYM VR 8250, DR 8550, CRT 8750, CRT 8770 models or any similar or higher range device
  • ATP Auto-switch function is programmed ON

You may not qualify if:

  • Presence of a contra-indication to the ICD therapy
  • Life expectancy less than 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Brest

Brest, France

Location

Study Officials

  • SAVOURE Arnaud, MD

    CHU Rouen

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 22, 2010

First Posted

July 26, 2010

Study Start

November 1, 2009

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 25, 2019

Record last verified: 2015-02

Locations

FR(1)