Adapta Pacing System Clinical Study

October 11, 2006 updated by: Medtronic Cardiac Rhythm and Heart Failure

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Freedom from adverse device effects

Secondary Outcome Measures

Outcome Measure
To assess right ventricular (lower right chamber of the heart) pacing
To summarize all adverse events reported in the study
To describe Adapta system performance as observed during Holter recording, save-to disk-files and technical observations
To evaluate the user acceptance of TherapyGuide via questionnaire data

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Investigators

  • Study Chair: Adapta Study Team, Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Study Completion

November 1, 2005

Study Registration Dates

First Submitted

March 17, 2006

First Submitted That Met QC Criteria

March 24, 2006

First Posted (ESTIMATE)

March 27, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

October 12, 2006

Last Update Submitted That Met QC Criteria

October 11, 2006

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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