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ULTRA Study for Pacemaker Patients

Primary Purpose

Bradycardia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pacemaker with Automatic Capture
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bradycardia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

  • Brigham and Women's Hospital

Outcomes

Primary Outcome Measures

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

Compare automatic and manual threshold tests
Project device longevity

Full Information

First Posted
August 19, 2005
Last Updated
July 9, 2007
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00133289
Brief Title
ULTRA Study for Pacemaker Patients
Official Title
Ventricular Automatic Capture Assessment Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Boston Scientific Corporation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
950 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Pacemaker with Automatic Capture
Primary Outcome Measure Information:
Title
Average ventricular voltage output over time for patients randomized to Automatic Capture feature ON versus patients randomized to Automatic Capture feature OFF
Secondary Outcome Measure Information:
Title
Compare automatic and manual threshold tests
Title
Project device longevity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Koplan, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22858177
Citation
Choi HY, Noh YH, Jin SJ, Kim YH, Kim MJ, Sung H, Jang SB, Lee SJ, Bae KS, Lim HS. Bioavailability and tolerability of combination treatment with revaprazan 200 mg + itopride 150 mg: a randomized crossover study in healthy male Korean volunteers. Clin Ther. 2012 Sep;34(9):1999-2010. doi: 10.1016/j.clinthera.2012.07.004. Epub 2012 Aug 1.
Results Reference
derived

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ULTRA Study for Pacemaker Patients

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