NCT02044315

Brief Summary

The aim of the present study is to investigate whether increasing detection zones can effectively reduce inappropriate ICD therapies in primary prevention patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
201

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_2

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

January 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
Last Updated

January 23, 2014

Status Verified

January 1, 2014

Enrollment Period

11 months

First QC Date

January 21, 2014

Last Update Submit

January 21, 2014

Conditions

Inappropriate ICD TherapyAppropriate ICD Therapy

Outcome Measures

Primary Outcomes (2)

  • First total inappropriate therapy

    Occurence of first total inappropriate therapy at 12-month follow-up

    12 months

  • Occurence of first total appropriate therapy at 12-month follow-up

    Occurence of first total appropriate therapy at 12-month follow-up

    12 months

Secondary Outcomes (2)

  • All-cause mortality

    12 months

  • Hospitalization for heart failure

    12 months

Study Arms (2)

Conventional

SHAM COMPARATOR

Conventional ICD programming

Device: ICD programming

High-zone

EXPERIMENTAL

High-zone ICD programming

Device: ICD programming

Interventions

ICD programmingDEVICE
ConventionalHigh-zone

Eligibility Criteria

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

You may qualify if:

  • \> 18 years
  • Cardiomyopathy (ischemic or not)
  • Current accepted indication for ICD implantation

You may not qualify if:

  • Previous device implantation
  • Secondary prevention patients
  • Pregnancy,
  • Primary electrical disorders,
  • Patient refusal,
  • \<1 year of expected mortality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuksek Ihtisas Hospital

Ankara, Cankaya, 06100, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 21, 2014

First Posted

January 23, 2014

Study Start

January 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 23, 2014

Record last verified: 2014-01

Locations

TU(1)