ULTRA Study for Pacemaker Patients

Bradycardia Clinical Trial

Official title:

Ventricular Automatic Capture Assessment Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00133289
• Other study ID #: CR-CA-051205-B
• Status: Completed
• Phase: Phase 4
• First received: August 19, 2005
• Last updated: July 9, 2007
• Start date: July 2005
• Est. completion date: June 2007

Study information

• Verified date: July 2007
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 950
• Est. completion date: June 2007
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bradycardia

Intervention

Device:
• Pacemaker with Automatic Capture

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average ventricular voltage output over time for patients randomized to Automatic Capture feature ON versus patients randomized to Automatic Capture feature OFF
Secondary	Compare automatic and manual threshold tests
Secondary	Project device longevity