Clinical Trials Directory

Trials / Completed

CompletedNCT01019213

Acute and Chronic Effect of His-pacing in Consecutive Patients With AV-block

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Aarhus University Hospital Skejby · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Conventional right ventricular (RV) apical pacing may result in asynchronous ventricular contraction with delayed left ventricular activation, interventricular motion abnormalities, and worsening of left ventricular ejection fraction. His pacing is preserving a synchronous contraction and may prevent a decrease in left ventricular ejection fraction. Hypothesis: His-pacing preserves left ventricular function and is a feasable alternative compared to RV septal septal pacing in patients with AV-block.

Detailed description

Conventional right ventricular apical pacing may result in asynchronous ventricular contraction with delayed left ventricular activation, interventricular motion abnormalities, and worsening of left ventricular ejection fraction. His pacing is preserving a synchronous contraction and may prevent a decrease in left ventricular ejection fraction. The aims of our crossover, double-blinded, randomized study is to evaluate the feasibility and long-term safety of permanent His pacing and to compare the effects on left ventricular ejection fraction of permanent His pacing with those of conventional right septal stimulation after 12 months treatment in patients with 2nd or 3rd degree AV-block.

Conditions

Interventions

TypeNameDescription
OTHERSeptal pacingSeptal lead activated
OTHERHis lead activatedHis lead will be activated 80 ms before septal lead

Timeline

Start date
2007-09-01
Primary completion
2011-09-01
Completion
2011-09-01
First posted
2009-11-25
Last updated
2012-05-15

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT01019213. Inclusion in this directory is not an endorsement.