ULTRA Study for Pacemaker Patients

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00133289
• Collaborator: (none)
• Enrollment: 950
• Location: 1
• Duration (Months): 23
• Patients Per Site Per Month: 41.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bradycardia	Device: Pacemaker with Automatic Capture	Phase 4

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Primary Purpose: Treatment
• Official Title: Ventricular Automatic Capture Assessment Study
• Study Start Date: Jul 1, 2005
• Actual Study Completion Date: Jun 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00133289
• Other Study ID Numbers: CR-CA-051205-B
• First Posted: Aug 23, 2005
• Last Update Posted: Jul 10, 2007
• Last Verified: Jul 1, 2007

• Additional relevant MeSH terms: Bradycardia

Study Results

No Results Posted as of Jul 10, 2007