Left Ventricular Function and Remodelling During Permanen... | NCT00228241

Studies
Left Ventricular Function and Remodelling During Permanent Pacing

NCT00228241

Sponsor

Aarhus University Hospital Skejby

Status

Unknown status

Last Update Posted

Oct 26, 2006Estimated

Enrollment

100

Phase

Not Applicable

Conditions

Sick Sinus Syndrome
AV-Block

Interventions

AAI vs. DDD vs. BIV pacing in different patients groups

Countries

Denmark

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

Sep 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2003

Primary Completion Date

Not provided

Completion Date

Jul 2006

First Submitted Date

Sep 26, 2005

First Submission Date that Met QC Criteria

Sep 26, 2005

First Posted Date

Sep 28, 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

Oct 25, 2006

Last Update Posted Date

Oct 26, 2006Estimated

Description Module

Brief Summary

Background - Pacemaker treatment gives asynchronous activation of the heart that often results in decreased heart function and clinical heart failure. New pacemaker types that stimulates both left and right ventricle ( biventricular pacemakers ) is introduced to the treatment of patients with heart failure, decreased left ventricular function and ECG signs with left bundle branch block.
Hypothesis - Ventricular pacing results in remodelling of the left ventricle and decreased left ventricular function. Biventricular pacing do not do this. Ventricular pacing results in heart failure and increased wall stress with decreased 6 minutes walk test and increased BNP in blood samples. This is not seen by biventricular pacing.
Materials and methods - 3 studies. All patients are examined by echocardiography 2-dimensional, M-mode, 3-dimensional and with tissue harmonic imaging. Study 1) Patients with AV-conduction disorder that needs pacemaker treatment are randomized to DDD-pacemaker or biventricular pacemaker. Study 2) Patients with sick sinus syndrome included in DANPACE are randomized to AAI- or DDD-pacemaker. Study 3 ) Acute study to examine the changes in patients AV-block before DDD-pacemaker implantation and after implantation.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100

Name	Type	Description	Arm Group Labels	Other Names
AAI vs. DDD vs. BIV pacing in different patients groups	Device

Measure	Description	Time Frame
3-dimensional left ventricular ejection fraction

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Sick sinus syndrome
AV-block

Exclusion Criteria:

Atrial fibrillation
AMI
Heart valve disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 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
Andi Albertsen, MD	Physician, Skejby University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Andi Eie Albertsen		Aarhus		8200	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21857020	Derived	Albertsen AE, Mortensen PT, Jensen HK, Poulsen SH, Egeblad H, Nielsen JC. Adverse effect of right ventricular pacing prevented by biventricular pacing during long-term follow-up: a randomized comparison. Eur J Echocardiogr. 2011 Oct;12(10):767-72. doi: 10.1093/ejechocard/jer136. Epub 2011 Aug 20.

ID	Term
D012804	Sick Sinus Syndrome
D054537	Atrioventricular Block

ID	Term
D001146	Arrhythmia, Sinus
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Measure	Description	Time Frame
TDI echo parameters
6 MHW
NT-proBNP