MODULA-Study: Modul 10: Benefit of CRT-Therapy in CRT-Pat... | NCT00180401

Studies
MODULA-Study: Modul 10: Benefit of CRT-Therapy in CRT-Patients With QRS-Complex of 120 - 150 Ms

NCT00180401

Sponsor

Boston Scientific Corporation

Status

Terminated

Last Update Posted

Feb 23, 2017Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Heart Failure

Interventions

CRT-P and CRT-D devices

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

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

no longer interest from medical community

Expanded Access Info

Start Date

Jun 2002

Primary Completion Date

Not provided

Completion Date

Oct 2007Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 16, 2005Estimated

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

The purpose of this study is to compare the benefit of cardiac resynchronization therapy (CRT)-therapy in patients with a QRS-complex of 120-150 ms to patients with a QRS-complex of > 150 ms.

Detailed Description

The objective of this study is to compare the benefit of CRT-therapy in patients with a QRS-complex of 120-150 ms to patients with a QRS-complex of > 150 ms within 12 months. A benefit is defined as change in quality of life and change in physical ability.

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

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
QRS 120-150 ms		Subjects with a QRS width between 120-150 ms	Behavioral: CRT-P and CRT-D devices
QRS >150 ms		Subjects with a QRS width >150 ms	Behavioral: CRT-P and CRT-D devices

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CRT-P and CRT-D devices	Behavioral		QRS 120-150 ms QRS >150 ms

Measure	Description	Time Frame
Observational: Benefit of CRT		12 month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with cardiac resynchronization therapy with a defibrillator (CRT-D) or cardiac resynchronization therapy pacemakers (CRT-P) system
New York Heart Association (NYHA) III
Ejection fraction (EF) below 35%
Optimised medical therapy
QRS-complex above 120 ms

Exclusion Criteria:

Patients with CRT-P and 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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andreas Tiroke, MD	Klinikum der Christian Albrecht Universität / Kardiologische Abteilung / Arnold Heller-Str. 7 / 24105 Kiel / Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum der Christian Albrecht Universität / Kardiologische Abteilung		Kiel		24105	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