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OpenTrials
Completed

NCT Number: NCT00286858

Beluga - Clinical Observations of Automatic Algorithms for Cardiac Pacing

This study shall evaluate in daily medical practice the clinical results of the AV delay hysteresis search algorithm in patients with a INSIGNIA ULTRA or AVT pacemaker implanted for one of the three following indications: sinus node dysfunction, atrial disease (or bradycardia/tachycardia) and atrio-ventricular paroxysmal block. In addition use and outcome of automatic functions will be evaluated.

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Key information

Conditions

Bradycardia Arrhythmia, Sinus Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sick Sinus Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU- Hôpital Nord, Amiens, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Dual chamber pacemaker (INSIGNIA ULTRA or AVT pacemaker), implant not older than 60 days, estimated life expectancy more than one year in case of associated illness, Age ≥ 18 years, signed patient information.

Exclusion criteria

  • Indication for conventional treatment with ventricular resynchronisation or by implantable defibrillator during inclusion, implanted for severe permanent AVB (AVB 2/1 and complete), PR > 250 ms, implant of the device older than 60 days before the inclusion date, Heart transplant foreseen within six months, unexplained syncope.

Treatment and study plan

Insignia Ultra and Insignia AVT

Device

Regular AV-Delay increase to allow for intrinsic AV conduction, if present.

Primary outcomes

  1. Impact of Atrio-ventricular hysteresis algorithm on percentage of Ventricular pacing

    Time frame: At 12 Months

    % Vp is compared between patients with atrio-ventricular hysteresis algorithm ON and OFF in patients with sino-atrial disease or paroxysmal AV block.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

Clinical Observations of Automatic Algorithms for Cardiac Pacing

Important dates

Study start
2006
Primary completion
2009
Study completion
2010
First posted
Feb 6, 2006
Registry last updated
Jan 28, 2021

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

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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.

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