MODULA Modul 5 BEAT-HF | NCT00273091

Studies
MODULA Modul 5 BEAT-HF

NCT00273091

Sponsor

Boston Scientific Corporation

Status

Completed

Last Update Posted

Feb 23, 2017Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Heart Failure

Interventions

ICD with CRT therapy

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2003

Primary Completion Date

Not provided

Completion Date

May 2007Actual

First Submitted Date

Jan 5, 2006

First Submission Date that Met QC Criteria

Jan 5, 2006

First Posted Date

Jan 9, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2017

Last Update Posted Date

Feb 23, 2017Actual

Name	Class
Guidant Corporation	INDUSTRY

Description Module

Brief Summary

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?

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Name	Type	Description	Arm Group Labels	Other Names
ICD with CRT therapy	Device	permanently CRT pacing

Measure	Description	Time Frame
Occurrence of atrial tachycardia in CRT patients		12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient under CRT-D or CRT-P therapy

Exclusion Criteria:

patients with permanent Atrial Fibrillation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Elegible patients comprise the investiagators standard CRT-D population.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Burkhard J. Hügl, phd	Herzzentrum / Klinik für Kardiologie / Robert-Koch-Allee 9 / 99437 Bad Berka / Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Herzzentrum / Klinik für Kardiologie / Robert-Koch-Allee 9		Bad Berka			Germany

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017147	Defibrillators, Implantable

Ancestor Terms

ID	Term
D047548	Defibrillators
D004566	Electrodes
D055615	Electrical Equipment and Supplies
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided