Adapta Pacing System Clinical Study

This study has been completed.
Sponsor:
Information provided by:
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00307073
First received: March 17, 2006
Last updated: October 11, 2006
Last verified: October 2006
  Purpose

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 Intervention
Pacemaker
Bradycardia
Device: Implantable Pulse Generator

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Adapta Clinical Study to Evaluate the Overall System Safety and Clinical Performance of the Adapta Pacing System

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Freedom from adverse device effects

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 120
Study Start Date: May 2005
Estimated Study Completion Date: November 2005
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00307073

Locations
Austria
Graz, Austria
Czech Republic
Prague, Czech Republic
Former Serbia and Montenegro
Belgrade, Former Serbia and Montenegro
Germany
Bad Nauheim, Germany
Hamburg, Germany
Netherlands
Heerlen, Netherlands
Sweden
Lund, Sweden
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Study Chair: Adapta Study Team Medtronic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00307073     History of Changes
Other Study ID Numbers: 201
Study First Received: March 17, 2006
Last Updated: October 11, 2006
Health Authority: Belgrade: Republic of Serbia - Ministry of Health and Environmental Protection

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Pacemaker
Managed Ventricular Pacing
Ventricular Pacing

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

ClinicalTrials.gov processed this record on July 28, 2014