Status:
COMPLETED
ULTRA Study for Pacemaker Patients
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Bradycardia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 featu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2007
Estimated Enrollment :
950 Patients enrolled
Trial Details
Trial ID
NCT00133289
Start Date
July 1 2005
End Date
June 1 2007
Last Update
July 10 2007
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115