Adapta Pacing System Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00307073
Recruitment Status : Completed
First Posted : March 27, 2006
Last Update Posted : October 12, 2006
Information provided by:
Medtronic Cardiac Rhythm and Heart Failure

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pacemaker Bradycardia Device: Implantable Pulse Generator Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Adapta Clinical Study to Evaluate the Overall System Safety and Clinical Performance of the Adapta Pacing System
Study Start Date : May 2005
Study Completion Date : November 2005

Primary Outcome Measures :
  1. Freedom from adverse device effects

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00307073

Graz, Austria
Czech Republic
Prague, Czech Republic
Former Serbia and Montenegro
Belgrade, Former Serbia and Montenegro
Bad Nauheim, Germany
Hamburg, Germany
Heerlen, Netherlands
Lund, Sweden
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Study Chair: Adapta Study Team Medtronic Identifier: NCT00307073     History of Changes
Other Study ID Numbers: 201
First Posted: March 27, 2006    Key Record Dates
Last Update Posted: October 12, 2006
Last Verified: October 2006

Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
Managed Ventricular Pacing
Ventricular Pacing

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes