NCT00133289

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
950

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 23, 2005

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

July 10, 2007

Status Verified

July 1, 2007

First QC Date

August 19, 2005

Last Update Submit

July 9, 2007

Conditions

Bradycardia

Outcome Measures

Primary Outcomes (1)

  • Average ventricular voltage output over time for patients randomized to Automatic Capture feature ON versus patients randomized to Automatic Capture feature OFF

Secondary Outcomes (2)

  • Compare automatic and manual threshold tests

  • Project device longevity

Interventions

Pacemaker with Automatic CaptureDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • 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.

    PMID: 22858177DERIVED

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bruce Koplan, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 19, 2005

First Posted

August 23, 2005

Study Start

July 1, 2005

Study Completion

June 1, 2007

Last Updated

July 10, 2007

Record last verified: 2007-07

Locations

US(1)