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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 20, 2014