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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00307073
Other study ID # 201
Secondary ID
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
Est. primary completion date
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


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
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