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.

Condition	Intervention	Phase
Bradycardia	Device: Pacemaker with Automatic Capture	Phase IV

Further Study Details: 

Primary Outcomes: Average ventricular voltage output over time for patients randomized to Automatic Capture feature ON versus patients randomized to Automatic Capture feature OFF
Secondary Outcomes: Compare automatic and manual threshold tests; Project device longevity
Expected Total Enrollment:  950

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00133289

Massachusetts
      Brigham and Women''''s Hospital, Boston,  Massachusetts,  02115,  United States; Recruiting

Study chairs or principal investigators

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

Study ID Numbers:  CR-CA-051205-B
Last Updated:  August 22, 2005
Record first received:  August 19, 2005
ClinicalTrials.gov Identifier:  NCT00133289
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-23