CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 67 enrolled
Drug / intervention
Vitatron pacemaker C20 SSIR or T20 SSIR modelsdevice
Likely dose
Vitatron pacemaker C20 SSIR or T20 SSIR models with VRS special function for heart rate regularizationAI-extracted
Key inclusion· 5
  • ✓Permanent atrial fibrillation with standard indication for VVI(R) pacing
  • ✓At least 1 episode of rate irregularity in the last month
  • ✓NYHA functional class I, II, or III
  • ✓Age >18 years
Key exclusion· 10
  • ✕Paroxysmal atrial fibrillation (only permanent AF eligible)
  • ✕NYHA functional class IV
  • ✕Left ventricular ejection fraction <35%
  • ✕Unstable angina

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

Search/NCT00246805
NCT00246805Phase 4Completed
CompareCT.gov

Post Marketing Study on Heart Rate Regularization in Patients With Permanent Atrial Fibrillation

Medtronic BRC·interventional·Posted Oct 31, 2005·Updated Sep 28, 2011

In Brief

A Phase 4 clinical trial evaluating Vitatron pacemaker C20 SSIR or T20 SSIR models for Permanent Atrial Fibrillation. Completed, enrolled 67 participants across 13 sites.

Detailed Summary

The purpose of this study is to monitor heart rate regularization in patients with permanent atrial fibrillation and standard indication for single chamber rate adaptive pacing VVI(R).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPermanent Atrial Fibrillation
CountriesItaly
CollaboratorsMedtronic

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 31, 2005
Enrollment StartJan 1, 2006
Primary CompletionJan 1, 2009
Study CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 20.7 years ago

Interventions

Vitatron pacemaker C20 SSIR or T20 SSIR modelsdevice

VRS: special function that automatically adapts pacing rate to regularize cardiac cycles