Bradycardia
Conditions
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.
Interventions
DEVICEPacemaker with Automatic Capture
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average ventricular voltage output over time for patients randomized to Automatic Capture feature ON versus patients randomized to Automatic Capture feature OFF | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare automatic and manual threshold tests | — |
| Project device longevity | — |
Countries
United States
Outcome results
None listed