ULTRA Study for Pacemaker Patients

Phase 4

Completed

• Conditions: Bradycardia

• Registration Number: NCT00133289
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

The ULTRA study will assess the difference in average ventricular voltage output for pacemaker patients randomized to Automatic Capture feature ON versus patients randomized to Automatic Capture feature OFF.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-08-19
• Study First Submitted QC: 2005-08-22
• Study First Posted: 2005-08-23
• Study Completion: 2007-06
• Status Verified: 2007-07
• Last Update Submitted: 2007-07-09
• Last Update Posted: 2007-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 950

Inclusion Criteria

• Patients who meet current INSIGNIA® Ultra pacemaker indications
• Patients who will be programmed to a pacing mode of DDD, DDDR, VVI, VVIR, or VDD at the time of implant
• Patients who sign and date a Patient Informed Consent form at or prior to the implant visit
• Patients who remain in the clinical care of the enrolling physician in approved centers

Exclusion Criteria

• Patients who will receive a single chamber device with an atrial lead only
• Patients who have chronic leads with a ventricular threshold of more than 4.0 V
• Patients whose life expectancy is less than 12 months
• Patients who are expected to receive a heart transplant during the duration of the study
• Patients who have or who are likely to receive a tricuspid valve prosthesis
• Patients who are currently enrolled in another investigational study that would directly impact the treatment or outcome of the ULTRA study.
• Patients who are younger than 18 years of age
• Patients who are pregnant
• Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Average ventricular voltage output over time for patients randomized to Automatic Capture feature ON versus patients randomized to Automatic Capture feature OFF

Secondary Outcome Measures

Name	Time	Method
Compare automatic and manual threshold tests
Project device longevity

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States