Completed

NCT Number: NCT00562107

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 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)

Completed

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Key information

Conditions

Assess the Benefits From the AAISafeR/SafeR Algorithm of Symphony 2550 or REPLYTM DR in a Wide Range of Pacemaker Patients.

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU - Hopital Sud, Amiens, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient primo-implanted with a Symphony 2550 or Reply DR for less than 1 month according to the official guidelines.
Patient implanted for sinus node dysfunction (including bradycardia-tachycardia syndrome) or 2nd, advanced or 3rd degree intermittent or allegedly permanent AV block.
Patient implanted with a bipolar right atrial lead and a right ventricular lead
Patient has signed a consent form after having received the appropriate information

Exclusion criteria

Patient with permanent AF
Patient suffering from sustained ventricular arrhythmias
Patient with congenital complete heart block
Patient with vasovagal syncope, carotid sinus syndrome
Patient with AV node ablation
Patient having suffered from a myocardial infarction within the last month
Patient suffering from severe aortic stenosis
Patient suffering from unstable angina pectoris
Patient is not able to understand the study objectives and protocol or refuses to co-operate
Patient is not available for scheduled follow-up
Patient has a life expectancy less than one year
Patient is included into another clinical study
Patient is minor, this is < 18 years
Patient is a pregnant woman
Any patient with a contra-indication for the device labeling

Treatment and study plan

Symphony DR 2550 and REPLY DR cardiac pacemakers

Device

AAISafeR/SafeR ON

Primary outcomes

The outcome measure is the % of ventricular pacing and hospitalizations for specified cardiac reasons (symptomatic AF, cardioversions for AF and heart failure)

Time frame: 3 years

Secondary outcomes

Evolution of paroxysmal AV blocks

Time frame: 3 years

Sponsors and collaborators

Lead sponsor

LivaNova

Industry

Registry information

Acronym: ANSWER

Important dates

Study start: 2007
Primary completion: 2011
Study completion: 2013
First posted: Nov 21, 2007
Registry last updated: Sep 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.