Left Ventricular Function and Remodelling During Permanent Pacing

NCT00228241 | Unknown

• 1 other identifier: 130472
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 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.

Conditions

Sick Sinus Syndrome; AV-Block

Keywords

Sick sinus syndrome; AV-block

Outcome Measures

Primary Outcomes (1)

• 3-dimensional left ventricular ejection fraction

Secondary Outcomes (3)

• TDI echo parameters

• 6 MHW

• NT-proBNP

Interventions

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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sick sinus syndrome
• AV-block

You may not qualify if:

• Atrial fibrillation
• AMI
• Heart valve disease

Sponsors & Collaborators

• Aarhus University Hospital Skejby: lead

Study Sites (1)

Andi Eie Albertsen

Aarhus, 8200, Denmark

Location

Related Publications (1)

• 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.

  PMID: 21857020 DERIVED

MeSH Terms

Conditions

Sick Sinus Syndrome; Atrioventricular Block

Condition Hierarchy (Ancestors)

Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Heart Block; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andi Albertsen, MD

  Physician, Skejby University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 26, 2005
• First Posted: September 28, 2005
• Study Start: September 1, 2003
• Study Completion: July 1, 2006
• Last Updated: October 26, 2006

Record last verified: 2005-09

Locations

DK (1)