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Study of the Loss of AV Synchrony at Maximum Exercise (SLAVSME)

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.
 
ClinicalTrials.gov Identifier: NCT03859167
Recruitment Status : Enrolling by invitation
First Posted : March 1, 2019
Last Update Posted : October 6, 2020
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Jay Montgomery, Vanderbilt University Medical Center

Brief Summary:
Investigators will identify a group of patients with complete heart block and a dual chamber pacemaker who will be expected to be able to exercise on a treadmill. Investigators will utilize symptom logs, cuff and continuous blood pressure monitoring. It is planned to study the symptomatic impact of loss of AV synchrony at significant levels of exercise.

Condition or disease Intervention/treatment
Exercise Pacemaker Blood Pressure Other: Stress Test

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: SLAVSME - Study of the Loss of AV Synchrony at Maximum Exercise
Actual Study Start Date : September 10, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Participants with AV block with pacemaker
Participants will have a stress test, and results will be collected and recorded.
Other: Stress Test
Participants will reach maximum exercise on a treadmill and results will be collected and recorded.




Primary Outcome Measures :
  1. The number of participants with Loss of AV synchrony at maximum exercise [ Time Frame: Baseline to end of stress test approximately 60 minutes. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
patients from cardiology clinic
Criteria

Inclusion Criteria:

  • Complete AV Block
  • Age less than 60
  • Easily programmable dual chamber pacemaker

Exclusion Criteria:

  • Age > 60
  • Significant Heart Failure
  • Significant angina
  • History of claudication
  • Significant orthopedic issues
  • Evidence of sinus node dysfunction
  • Taking beta blockers or non-dihydropyridine calcium channel blockers

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): NCT03859167


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Medtronic
Investigators
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Principal Investigator: Jay A. Montgomery, MD Vanderbilt University Medical Center
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Responsible Party: Jay Montgomery, Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03859167    
Other Study ID Numbers: 190470
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No