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

April 11, 2023 updated by: Jay Montgomery, Vanderbilt University Medical Center

SLAVSME - Study of the Loss of AV Synchrony at Maximum Exercise

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

patients from cardiology clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Collaborators

Medtronic

Investigators

  • Principal Investigator: Jay A. Montgomery, MD, Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2019

Primary Completion (Actual)

April 10, 2023

Study Completion (Actual)

April 10, 2023

Study Registration Dates

First Submitted

February 27, 2019

First Submitted That Met QC Criteria

February 27, 2019

First Posted (Actual)

March 1, 2019

Study Record Updates

Last Update Posted (Actual)

April 14, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 190470

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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