Left Ventricular Function and Remodelling During Permanent Pacing

Sick Sinus Syndrome Clinical Trial

Official title:

Left Ventricular Function and Remodelling During Permanent Pacing

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00228241
• Other study ID #: 130472
• Status: Active, not recruiting
• Phase: N/A
• First received: September 26, 2005
• Last updated: October 25, 2006
• Start date: September 2003
• Est. completion date: July 2006

Study information

• Verified date: September 2005
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

1. 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.

2. 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.

3. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Sick sinus syndrome

• AV-block

Exclusion Criteria:

• Atrial fibrillation

• AMI

• Heart valve disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• AV-Block
• Sick Sinus Syndrome

Intervention

Device:
• AAI vs. DDD vs. BIV pacing in different patients groups

Locations

Country	Name	City	State
Denmark	Andi Eie Albertsen	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital Skejby

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-dimensional left ventricular ejection fraction
Secondary	TDI echo parameters
Secondary	6 MHW
Secondary	NT-proBNP