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MODULA Modul 5 BEAT-HF

This study has been completed.
Sponsor:
Information provided by:
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00273091
First received: January 5, 2006
Last updated: April 22, 2009
Last verified: April 2009
History of Changes
  Purpose

Detektion and Registration of Atrial Tachyarrhythmias at Patients with Heart Failure; What proportion of patients with CRT-therapy are affected at least temporarily by Atrial Arrhythmia?


Condition Intervention Phase
Heart Failure
 Device: ICD with CRT therapy
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: MODULA-Study: Modul 5 / BEAT HF: Detektion and Registration of Atrial Tachyarrhythmias at Patients With Heart Failure

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Guidant Corporation:

Estimated Enrollment: 100
Study Start Date: August 2003
Study Completion Date: May 2007
Intervention Details:
    Device: ICD with CRT therapy
    permanently CRT pacing
Detailed Description:

How many patients with CRT-therapy are affected at least temporarily by Atrial Arrhythmia in terms of rate, characteristics and severity of atrial rhythm disturbances at patients with CRT-therapy within 12 months after implantation of a CRT-device.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Elegible patients comprise the investiagators standard CRT-D population.

Criteria

Inclusion Criteria:

  • patient under CRT-D or CRT-P therapy

Exclusion Criteria:

  • patients with permanent Atrial Fibrillation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00273091

Locations
Germany
Herzzentrum / Klinik für Kardiologie / Robert-Koch-Allee 9
99437 Bad Berka, Germany
Sponsors and Collaborators
Guidant Corporation
Investigators
Principal Investigator: Burkhard J. Hügl, phd Herzzentrum / Klinik für Kardiologie / Robert-Koch-Allee 9 / 99437 Bad Berka / Germany
  More Information

No publications provided

Responsible Party: jens goetzke, guidant germany a boston scientific company
ClinicalTrials.gov Identifier: NCT00273091     History of Changes
Other Study ID Numbers: Version vom 10.07.2003
Study First Received: January 5, 2006
Last Updated: April 22, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013