Clinical Trials Logo

Clinical Trial Summary

This clinical investigation is a prospective, single-blinded, randomized trial. The primary objective concerns the safety and effectiveness of the AAIsafeR mode with the preventive algorithms.


Clinical Trial Description

In this study, patients are randomized to DDD mode, AAIsafeR mode, or AAIsafeR mode plus atrial arrhythmia preventive algorithms. The atrial arrhythmia (AA) burden serves as the primary measure of effectiveness. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT01170611
Study type Interventional
Source LivaNova
Contact
Status Completed
Phase Phase 4
Start date July 2004
Completion date January 2007

See also
  Status Clinical Trial Phase
Terminated NCT04093414 - Left Bundle Area Versus Selective His Bundle Pacing N/A
Enrolling by invitation NCT03903107 - The Fluoroless-CSP Trial Using Electroanatomic Mapping N/A
Completed NCT01688843 - Safety and Performance Study of the INGEVITY Lead N/A
Completed NCT03719040 - Physiologic Pacing Registry
Completed NCT02027909 - A Comparison of Rate Response Performance in Pacemaker Patients With an Indication of Sinus Node Dysfunction
Completed NCT00655213 - Spontaneous Atrio Ventricular Conduction Preservation Phase 4
Recruiting NCT05186220 - Cardioneuroablation Versus Pacemaker Implantation for the Treatment of Symptomatic Sinus Node Dysfunction N/A
Recruiting NCT05766462 - Allometric-Pace Study
Recruiting NCT05196126 - Permanent Pacemaker Implantation or Cardioneuroablation in Sinus Node Dysfunction N/A
Active, not recruiting NCT03607123 - Atrial Fibrillation With Sinus Node Dysfunction: Intensive Device Follow-up
Completed NCT01643707 - Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)
Completed NCT03601754 - Effectiveness of Closed Loop Stimulation (CLS) With His Bundle Lead Placement N/A
Completed NCT01781078 - ImageReady(TM) MR Conditional Pacing System Clinical Study N/A
Active, not recruiting NCT05887323 - LBBAP Data Collection Registry
Completed NCT04632641 - Suture Closure AFtEr VEIN Access for Cardiac Procedures (SAFE-VEIN) Trial N/A
Completed NCT02586480 - Evolution of the PR Interval in Patients Implanted With a Pacemaker Using the SafeR Mode N/A