NCT03446326

Brief Summary

The investigators will seek to determine the effects of different heart rates on both stroke volume and cardiac output using non-invasive hemodynamic assessments. In order to safely manipulate the HR, the investigators will study patients with permanent pacemakers in whom heart rate manipulation can be done in a safe and non-invasive manner.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress83%
Jan 2018Jan 2028

Study Start

First participant enrolled

January 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 26, 2018

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

9 years

First QC Date

January 31, 2018

Last Update Submit

April 30, 2026

Conditions

Vasovagal Syncope

Keywords

pacemakerstroke volumecardiac outputheart rate

Outcome Measures

Primary Outcomes (1)

  • Change in cardiac output while atrial pacing at lower and higher rates while supine

    Change in cardiac output (CO) when atrial pacing at 80 bpm \& 120 bpm while supine. CO = HR x Stroke volume (SV)

    1 day

Secondary Outcomes (7)

  • Change in cardiac output at lower and higher ventricular (VVI) paced rates while supine

    1 day

  • Change of cardiac output at lower and higher atrial (AAI) paced rates while supine versus while upright

    1 day

  • Change of cardiac output at lower and higher ventricular (VVI) paced rates while supine versus while upright

    1 day

  • Change in stroke volume at lower and higher atrial paced rates while tilted up

    1 day

  • Change in stroke volume at lower and higher ventricular (VVI) paced rates while tilted up

    1 day

  • +2 more secondary outcomes

Study Arms (1)

Stroke volume and cardiac output

EXPERIMENTAL

Pacing runs will occur at the following rates: * 50 beats per minute (bpm) * 60 bpm * 70 bpm * 80 bpm * 90 bpm * 100 bpm * 110 bpm * 120 bpm * 130 bpm The finger blood pressure cuff will be calibrated between pacing runs. Following the final pacing run while supine, the patient will be given 10 minutes to rest prior to the upright portion of the study. They will then be strapped into the table (so they will not fall) and then they will be tilted up to \>70 degrees (almost standing up). They will stand for \~10 minutes prior to commencing the next pacing trains.

Device: Pacing

Interventions

PacingDEVICE

Assess the non-invasively determined stroke volume and cardiac output response at different paced heart rates in patients with a cardiac pacemaker or implanted defibrillator with preserved ejection fractions (LVEF≥50%)

Stroke volume and cardiac output

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-70 years (inclusive)
  • Implanted permanent pacemaker or implanted defibrillator capable of atrial and ventricular pacing
  • LV ejection fraction \>50%

You may not qualify if:

  • Unable or unwilling to provide informed consent
  • Clinical need for a cardiac resynchronization device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

RECRUITING

MeSH Terms

Conditions

Syncope, Vasovagal

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesSyncopeUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Satish R Raj, MD MSCI

    University of Calgary

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Satish R Raj, MD MSCI

CONTACT

4032106152satish.raj@ucalgary.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2018

First Posted

February 26, 2018

Study Start

January 1, 2018

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)