ULTRA Study for Pacemaker Patients

Completed · Phase 4

Conditions studied: Bradycardia

In brief

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.

Key facts

Study ID

NCT00133289

Run by

Boston Scientific Corporation

People needed

950

Starts

2005-07-01

Expected to finish

2007-06-01

Last updated by the study team

2007-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.