Study of the Loss of AV Synchrony at Maximum Exercise

NCT ID: NCT03859167

Last Updated: 2023-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-10

Study Completion Date

2023-04-10

Brief Summary

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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.

Detailed Description

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Conditions

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Exercise Pacemaker Blood Pressure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with AV block with pacemaker

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

Stress Test

Intervention Type OTHER

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

Interventions

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Stress Test

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jay Montgomery

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jay A. Montgomery, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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190470

Identifier Type: -

Identifier Source: org_study_id

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