NCT03859167

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 1, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

September 10, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2023

Completed
Last Updated

April 14, 2023

Status Verified

April 1, 2023

Enrollment Period

3.6 years

First QC Date

February 27, 2019

Last Update Submit

April 11, 2023

Conditions

ExercisePacemakerBlood Pressure

Outcome Measures

Primary Outcomes (1)

  • The number of participants with Loss of AV synchrony at maximum exercise

    Baseline to end of stress test approximately 60 minutes.

Study Arms (1)

Participants with AV block with pacemaker

Participants will have a stress test, and results will be collected and recorded.

Other: Stress Test

Interventions

Stress TestOTHER

Participants will reach maximum exercise on a treadmill and results will be collected and recorded.

Participants with AV block with pacemaker

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patients from cardiology clinic

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Jay A. Montgomery, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 27, 2019

First Posted

March 1, 2019

Study Start

September 10, 2019

Primary Completion

April 10, 2023

Study Completion

April 10, 2023

Last Updated

April 14, 2023

Record last verified: 2023-04

Locations

US(1)