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NCT00562107 · ClinicalTrials.gov registry record · Phase 4

Evaluation of the SafeR Mode in Patients With a Dual Chamber Pacemaker Indication

A Phase 4 study, sponsored by LivaNova.

Completed
Registry status
Phase 4
Development phase
650
Enrollment target

NCT00562107 is a Phase 4 study that has completed, run by LivaNova. The registered enrollment target is 650 participants.

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The verdict

NCT00562107, a Phase 4 study, has completed, sponsored by LivaNova.

COMPLETED
Registry status
Phase 4
Development phase
650 participants
Enrollment target

Study Summary

The aim of this study is to assess the benefits from the AAISafeR/SafeR algorithm of Symphony 2550 or REPLY DR in a wide range of pacemaker patients. The expected benefits will be a result of the reduction of the percentage of ventricular pacing. It contributes to the longevity of the cardiac pacemaker and has an effect on the incidence of sustained (or persistent) Atrial Fibrillation and Heart Failure. These clinical benefits are a result of spontaneous ventricular activation which ensures a more physiological ventricular activation. The benefits will be assessed by comparing the incidence of atrial arrhythmias and the evolution of the haemodynamic status of the patients (QOL, echo and BNP)

Interventions

  • DEVICE Symphony DR 2550 and REPLY DR cardiac pacemakers

Trial Details

FieldValue
Enrollment Target 650 participants
Start Date 2007-12
Est. Completion 2013-04
Phase Phase 4

Sponsor

LivaNova

13 total trials

What the Registry Record Tells You About NCT00562107

The ClinicalTrials.gov registry entry for NCT00562107 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 650 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is LivaNova, which has 13 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Symphony DR 2550 and REPLY DR cardiac pacemakers is the first listed.

NCT00562107 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00562107 about?

NCT00562107 is a clinical study titled "Evaluation of the SafeR Mode in Patients With a Dual Chamber Pacemaker Indication". The aim of this study is to assess the benefits from the AAISafeR/SafeR algorithm of Symphony 2550 or REPLY DR in a wide range of pacemaker patients. The expected benefits will be a result of the reduction of the percentage of ventricular pacing. It contributes to the longevity of the cardiac pace...

What is the current status of trial NCT00562107?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 650 participants. The study started on 2007-12. Estimated completion is 2013-04.

What interventions are being tested in trial NCT00562107?

The interventions under investigation include: Symphony DR 2550 and REPLY DR cardiac pacemakers (DEVICE).

Who is sponsoring clinical trial NCT00562107?

This trial is sponsored by LivaNova, which has 13 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.