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LIFE Study - Limiting Chronotropic Incompetence for Pacemaker Recipients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00146861
First Posted: September 7, 2005
Last Update Posted: May 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Boston Scientific Corporation
  Purpose
This study will compare how two different sensors inside the pacemaker may affect patients' quality of life.

Condition Intervention Phase
Bradycardia Device: sensor programming Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Official Title: Limiting Chronotropic Incompetence for Pacemaker Recipients

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Determine the prevalence of CI among a general sample of pacemaker patients, compare differences in quality of life and physical activity between patients programmed to either blended sensor or accelerometer

Secondary Outcome Measures:
  • Evaluate changes in chronotropic response among CI patients who are randomized to receive adaptive rate therapy driven by either blended sensor or accelerometer

Estimated Enrollment: 1500
Actual Study Start Date: July 2003
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Detailed Description:
The LIFE Study will estimate the prevalence of CI among a general sample of pacemaker patients and compare changes in quality of life and physical activity between patients randomized to receive rate response driven by either blended sensor or accelerometer. Changes in chronotropic response between CI patients randomized to either blended sensor or accelerometer will be compared. A sub-study will evaluate changes in functional capacity between CI patients randomized to either blended sensor or accelerometer.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who meet current INSIGNIATM Plus pacemaker indications
  • Patients who sign and date a Patient Informed Consent prior to device implant
  • Patients who remain in the clinical care of the enrolling physician

Exclusion Criteria:

  • Patients whose previous pacemaker had a minute ventilation sensor
  • Patients who have neuromuscular, orthopedic, or vascular disability that prevents normal walking (e.g., intermittent claudication, arthritis, residual stroke weakness, need for a wheelchair or walker)
  • Patients in whom a symptom-limited exercise protocol is thought to be dangerous because of coronary artery disease or other cardiac disease
  • Uncontrolled arrhythmias (e.g., chronic atrial fibrillation, frequent/persistent atrial fibrillation, ventricular arrhythmias, or patients with ablate and pace whose arrhythmia continues to be uncontrolled)
  • Patients whose medical condition is expected to preclude the use of the protocol-required primary pacing mode (i.e., DDD or DDDR)
  • Patients whose life expectancy is less than 12-months due to other medical conditions
  • Patients who have or who are indicated for an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D)
  • Patients who have active chronic leads that are either single-pass VDD, unipolar ventricular and atrial, non-IS-1, and non-3.2mm UNLESS the leads are replaced with bipolar leads that are IS-1/3.2mm compatible
  • Patients who are currently enrolled in another investigational study that would directly impact the treatment or outcome of the current study. Each instance should be brought to the attention of Guidant's Clinical Application Research Studies (CARS) group to determine eligibility
  • 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 or participate in the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00146861


Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: James Coman, MD Oklahoma Heart Institute
  More Information

ClinicalTrials.gov Identifier: NCT00146861     History of Changes
Other Study ID Numbers: CR-CA-062703-B
First Submitted: September 2, 2005
First Posted: September 7, 2005
Last Update Posted: May 18, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes