Study of the Loss of AV Synchrony at Maximum Exercise

Blood Pressure Clinical Trial

— SLAVSME  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03859167
• Other study ID #: 190470
• Status: Terminated
• Start date: September 10, 2019
• Est. completion date: April 10, 2023

Study information

• Verified date: April 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: April 10, 2023
• Est. primary completion date: April 10, 2023
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Exercise
• Pacemaker

Intervention

Other:
• Stress Test
Participants will reach maximum exercise on a treadmill and results will be collected and recorded.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of participants with Loss of AV synchrony at maximum exercise		Baseline to end of stress test approximately 60 minutes.