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ULTRA Study for Pacemaker Patients

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ClinicalTrials.gov Identifier: NCT00133289
Recruitment Status : Completed
First Posted : August 23, 2005
Last Update Posted : July 10, 2007
Sponsor:
Information provided by:
Boston Scientific Corporation

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.

Condition or disease Intervention/treatment Phase
Bradycardia Device: Pacemaker with Automatic Capture Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 950 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Ventricular Automatic Capture Assessment Study
Study Start Date : July 2005
Actual Study Completion Date : June 2007



Primary Outcome Measures :
  1. Average ventricular voltage output over time for patients randomized to Automatic Capture feature ON versus patients randomized to Automatic Capture feature OFF

Secondary Outcome Measures :
  1. Compare automatic and manual threshold tests
  2. Project device longevity


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00133289


Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Bruce Koplan, MD Brigham and Women's Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00133289     History of Changes
Other Study ID Numbers: CR-CA-051205-B
First Posted: August 23, 2005    Key Record Dates
Last Update Posted: July 10, 2007
Last Verified: July 2007

Additional relevant MeSH terms:
Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes