ULTRA Study for Pacemaker Patients - Full Text View

Purpose

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

Genetics Home Reference related topics:

Brugada syndrome short QT syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment

Official Title:	Ventricular Automatic Capture Assessment Study

Further study details as provided by Boston Scientific Corporation:

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

Estimated Enrollment:	950
Study Start Date:	July 2005
Study Completion Date:	June 2007

Eligibility

Ages Eligible for Study:	18 Years and older
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Study ID Numbers:	CR-CA-051205-B
First Received:	August 19, 2005
Last Updated:	July 9, 2007
ClinicalTrials.gov Identifier:	NCT00133289
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Heart Diseases

Bradycardia

Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes

Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 05, 2008

Sponsored by:	Boston Scientific Corporation
Information provided by:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT00133289