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Left Ventricular Function and Remodelling During Permanent Pacing

Left Ventricular Function and Remodelling During Permanent Pacing

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00228241
Enrollment
100
Registered
2005-09-28
Start date
2003-09-30
Completion date
2006-07-31
Last updated
2006-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AV-Block, Sick Sinus Syndrome

Keywords

Sick sinus syndrome, AV-block

Brief 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.

Interventions

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

Sponsors

Aarhus University Hospital Skejby
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Sick sinus syndrome * AV-block

Exclusion criteria

* Atrial fibrillation * AMI * Heart valve disease

Design outcomes

Primary

MeasureTime frame
3-dimensional left ventricular ejection fraction

Secondary

MeasureTime frame
TDI echo parameters
6 MHW
NT-proBNP

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026