NCT00180362

Brief Summary

The purpose of this study is to evaluate the strategy of implanting an ICD with or without EPS before, during and after ICD-implantation in a randomised controlled trial, using a combined endpoint of major ICD-related adverse events as the primary outcome measure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2004

Shorter than P25 for phase_4

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

May 1, 2004

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

First QC Date

September 12, 2005

Last Update Submit

February 17, 2017

Conditions

Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

  • Combined endpoint of major ICD-related adverse events as the primary outcome measure

Secondary Outcomes (1)

  • Costs, quality of life, differences in decision making, cardiovascular events , 18 months FU

Interventions

procedureDEVICE

Eligibility Criteria

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

You may qualify if:

  • structural heart disease and survived cardiac arrest or hemodynamically unstable VT (bpm \> 200/min)

You may not qualify if:

  • conditions, which make a secondary cause for cardiac arrest probable or are not compatible with a single chamber ICD; co-morbidity, prior ICD PM, or EPS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allg. Krankenhaus St. Georg

Hamburg, D-20099, Germany

Location

MeSH Terms

Conditions

Heart Arrest

Interventions

Methods

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • K. H Kuck, MD

    Allg. Krankenhaus St. Georg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

May 1, 2004

Study Completion

September 1, 2004

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

DE(1)