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

Sponsor

Vanderbilt University Medical Center (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03859167

Collaborator

Medtronic (Industry)

Enrollment

Location

39.7

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Exercise Pacemaker Blood Pressure	Other: Stress Test

Study Design

Study Type:

Observational

Anticipated 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 :

Sep 10, 2019

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

The number of participants with Loss of AV synchrony at maximum exercise [Baseline to end of stress test approximately 60 minutes.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

Vanderbilt University Medical Center
Medtronic

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jay Montgomery, Assistant Professor, Vanderbilt University Medical Center

ClinicalTrials.gov Identifier:

NCT03859167

Other Study ID Numbers:

190470

First Posted:

Mar 1, 2019

Last Update Posted:

Mar 22, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 22, 2022