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Completed

NCT Number: NCT00133289

ULTRA Study for Pacemaker Patients

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.

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Key information

Conditions

Bradycardia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pacemaker with Automatic Capture

Device

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

  1. Compare automatic and manual threshold tests

  2. Project device longevity

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

Ventricular Automatic Capture Assessment Study

Important dates

Study start
2005
Study completion
2007
First posted
Aug 23, 2005
Registry last updated
Jul 10, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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