- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00273091
MODULA Modul 5 BEAT-HF
February 17, 2017 updated by: Boston Scientific Corporation
MODULA-Study: Modul 5 / BEAT HF: Detektion and Registration of Atrial Tachyarrhythmias at Patients With Heart Failure
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?
Study Overview
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.
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bad Berka, Germany
- Herzzentrum / Klinik für Kardiologie / Robert-Koch-Allee 9
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Elegible patients comprise the investiagators standard CRT-D population.
Description
Inclusion Criteria:
- patient under CRT-D or CRT-P therapy
Exclusion Criteria:
- patients with permanent Atrial Fibrillation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Occurrence of atrial tachycardia in CRT patients
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Burkhard J. Hügl, phd, Herzzentrum / Klinik für Kardiologie / Robert-Koch-Allee 9 / 99437 Bad Berka / Germany
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2003
Primary Completion
December 7, 2022
Study Completion (Actual)
May 1, 2007
Study Registration Dates
First Submitted
January 5, 2006
First Submitted That Met QC Criteria
January 5, 2006
First Posted (Estimate)
January 9, 2006
Study Record Updates
Last Update Posted (Actual)
February 23, 2017
Last Update Submitted That Met QC Criteria
February 17, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Version vom 10.07.2003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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