Expired Study
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Boston, Massachusetts 02115


Purpose:

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.


Criteria:

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


NCT ID:

NCT00133289


Primary Contact:

Principal Investigator
Bruce Koplan, MD
Brigham and Women's Hospital


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02115
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 17, 2017

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