Adapta Pacing System Clinical Study

NCT00307073 | Completed

• 1 other identifier: 201
• Study Type: interventional
• Target: 120
• Locations: 5 countries
• Sites: 6

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.

Conditions

Pacemaker; Bradycardia

Keywords

Pacemaker; Managed Ventricular Pacing; Ventricular Pacing

Outcome Measures

Primary Outcomes (1)

• Freedom from adverse device effects

Secondary Outcomes (4)

• 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

Interventions

Implantable Pulse Generator DEVICE

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (7)

Unknown Facility

Graz, Austria

Location

Unknown Facility

Prague, Czechia

Location

Unknown Facility

Bad Nauheim, Germany

Location

Unknown Facility

Hamburg, Germany

Location

Unknown Facility

Heerlen, Netherlands

Location

Unknown Facility

Belgrade, Serbia and Montenegro

Location

Unknown Facility

Lund, Sweden

Location

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Adapta Study Team

  Medtronic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 17, 2006
• First Posted: March 27, 2006
• Study Start: May 1, 2005
• Study Completion: November 1, 2005
• Last Updated: October 12, 2006

Record last verified: 2006-10

Locations

CZ (1); NL (1); DE (2); AU (1); SE (1)