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Completed

NCT Number: NCT00307073

Adapta Pacing System Clinical Study

Pacemakers are implantable devices that pace (electrically stimulate) the heart. Some pacemakers have special programs to treat irregular atrial rhythms(top chambers of the heart beat too fast or too slow). Advances in pacemaker technology in recent years include features that automatically adapt to patient conditions without intervention from the clinician. Adapta (Model #ADDR01) is a new pacemaker that is designed to provide further automaticity advances by including the managed ventricular pacing (MVP) feature designed to promote intrinsic conduction (natural flow of electricity in the heart) by reducing unnecessary ventricular (lower chamber of the heart) pacing (electrical impulses). Adapta also contains a feature called TherapyGuide that is designed to allow the user to select certain conditions for each subject and receive a list of suggested pacemaker parameter value changes based on those conditions. The purpose of this study is to evaluate the overall system safety and clinical performance of the Adapta pacing system.

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Key information

Conditions

Pacemaker Arrhythmias, Cardiac Bradycardia Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

0 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Graz, Austria

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects who have a Class I or II indication for implantation of a dual chamber pacemaker according to ACC/AHA/NASPE guidelines
  • Subjects who have signed a Medical Ethics Committee (MEC) approved Informed Consent Form

Exclusion criteria

  • Subjects with a mechanical tricuspid valve
  • Subjects with a life expectancy less than two years
  • Subjects with a Class III indication for permanent pacing
  • Subjects with lead integrity problems, unless leads are being replaced

Treatment and study plan

Implantable Pulse Generator

Device

Primary outcomes

  1. Freedom from adverse device effects

Secondary outcomes

  1. To assess right ventricular (lower right chamber of the heart) pacing

  2. To summarize all adverse events reported in the study

  3. To describe Adapta system performance as observed during Holter recording, save-to disk-files and technical observations

  4. To evaluate the user acceptance of TherapyGuide via questionnaire data

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

Adapta Clinical Study to Evaluate the Overall System Safety and Clinical Performance of the Adapta Pacing System

Important dates

Study start
2005
Study completion
2005
First posted
Mar 27, 2006
Registry last updated
Oct 12, 2006

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.

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