CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,833 enrolled
Drug / intervention
Biventricular Pacing +1 moredevice
Likely dose
Not stated in record
Key inclusion· 8
  • ✓Indication for ventricular pacing per guidelines for permanent or intermittent 3rd degree AV block, 2nd degree AV block Mobitz II, or 1st degree AV block with pQ-interval ≥220 ms requiring frequent/permanent ventricular pacing
  • ✓Sick-sinus-syndrome with symptomatic bradycardia/sinus arrest and long 1st degree AV block (pQ ≥220 ms)
  • ✓Chronic atrial fibrillation/flutter with resting ventricular rate ≤60/min, or ≤75/min if negative chronotropic therapy planned post-implant
  • ✓Scheduled for AV node ablation
Key exclusion· 10
  • ✕Implanted ICD or consideration for ICD implant for arrhythmia indication (except primary prevention in LVEF ≤35%)
  • ✕Prior implanted ventricular pacing device
  • ✕Status 1 heart transplant candidate with likelihood of transplant within 2 years
  • ✕Acute LV dysfunction with high reversibility probability (e.g., acute myocarditis, tachycardiomyopathy)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT00187278N/ACompleted
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Biventricular Pacing for Atrioventricular Block in Left Ventricular Dysfunction to Prevent Cardiac Desynchronization

Abbott Medical Devices·interventional·Posted Sep 16, 2005·Updated Jan 25, 2021

In Brief

A clinical study evaluating Biventricular Pacing and RV Pacing for Atrioventricular Block and Ventricular Dysfunction. Completed, enrolled 1,833 participants across 1 site.

Detailed Summary

The primary purpose of the study is to evaluate if patients with a standard indication for permanent ventricular pacing, left ventricular ejection fraction without limit, or any QRS duration will profit from the prevention of ventricular desynchronisation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrioventricular Block, Ventricular Dysfunction
CountriesGermany
Collaborators--

Timeline

N/ACompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartMay 1, 2003
Primary CompletionMay 1, 2014
Study CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 11 yearsPosted 20.8 years ago

Interventions

Biventricular Pacingdevice

Biventricular Pacemaker implant

RV Pacingdevice

Standard Pacemaker implant