NCT00180427

Brief Summary

"The purpose of this study is to evaluate the influence of the rate response function of implantable cardioverter defibrillators (ICDs) on the frequency of ventricular arrhythmias in patients with an ICD."

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2001

Longer than P75 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

June 1, 2001

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
11 months 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

April 24, 2008

Status Verified

April 1, 2008

First QC Date

September 12, 2005

Last Update Submit

April 22, 2008

Conditions

Ventricular Fibrillation

Outcome Measures

Primary Outcomes (1)

  • frequency of ventricular arrhythmias at 6 and 12 months follow ups

Secondary Outcomes (1)

  • medication, anamnesis, quality of life, 6 min walktest, echocardiographic parameters and optionally spiroergomatry at 6 and 12 months follow ups,

Interventions

ICDDEVICE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • indication for an ICD according to ACC/AHA guidelines
  • ICD with rate response function implanted
  • at least 5% rate response ventricular pacing during the one month screening phase
  • signed informed patient consent"

You may not qualify if:

  • rate responsive pacing contraindicated
  • patient not able to perform 6 min walktest
  • heart failure NYHA IV
  • life expectancy below 18 months"

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medizinische Klinik der Medizinischen Hochschule

Hanover, Germany

Location

MeSH Terms

Conditions

Ventricular Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Niehaus, MD

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

June 1, 2001

Study Completion

November 1, 2004

Last Updated

April 24, 2008

Record last verified: 2008-04

Locations

DE(1)