Adapta Pacing System Clinical Study

Bradycardia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00307073
• Other study ID #: 201
• Status: Completed
• Phase: N/A
• First received: March 17, 2006
• Last updated: October 11, 2006
• Start date: May 2005
• Est. completion date: November 2005

Study information

• Verified date: October 2006
• Source: Medtronic Cardiac Rhythm Disease Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgrade: Republic of Serbia - Ministry of Health and Environmental Protection
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bradycardia
• Pacemaker

Intervention

Device:
• Implantable Pulse Generator

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm Disease Management

Countries where clinical trial is conducted

Austria,  Czech Republic,  Former Serbia and Montenegro,  Germany,  Netherlands,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from adverse device effects
Secondary	To assess right ventricular (lower right chamber of the heart) pacing
Secondary	To summarize all adverse events reported in the study
Secondary	To describe Adapta system performance as observed during Holter recording, save-to disk-files and technical observations
Secondary	To evaluate the user acceptance of TherapyGuide via questionnaire data