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RecruitingNCT03446326Pacing_SVUpdated May 5, 2026

Assessment of Stroke Volume and Cardiac Output in Response to Varying Heart Rates

An interventional study of Pacing in Vasovagal Syncope, sponsored by University of Calgary. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-05.

Sponsored by University of Calgary · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

Permanent pacemakers have sometimes been used to treat patients with recurrent vasovagal syncope. This is because patients with vasovagal syncope often experience bradycardia at the time of their syncope. Unfortunately, pacemakers are often ineffective in preventing syncope.

Classical cardiovascular hemodynamics would suggest that increasing the heart rate (HR; via pacemaker) should increase the cardiac output (CO). This is because:

CO = HR x Stroke volume (SV).

The assumption is that the SV is fixed during manipulation of the HR. However, this might not be the case. As the number of beats per minute (HR) increases, the cardiac cycle length (R-R interval [RRI]) shortens, as a function of simple math. This means that the time in cardiac systole shortens, and the time in cardiac diastole shortens. Since cardiac diastole is when the heart fills up with blood, faster HR can be associated with decreased cardiac filling times. This, in turn, could compromise the SV. However, there is a paucity of data as to what happens to SV and CO at different HR. Further, it is possible that these effects will be different when a person is lying down supine versus when a patient is upright (when stroke volume will be lower).

The investigators will seek to determine the effects of different HR on both SV \& CO. In order to safely manipulate the HR, they will study patients with permanent pacemakers in whom HR manipulation can be done in a safe and non-invasive manner.

02

Conditions studied

  • Vasovagal Syncope

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Keywords

  • pacemaker
  • stroke volume
  • cardiac output
  • heart rate
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Unable or unwilling to provide informed consent
  • Clinical need for a cardiac resynchronization device
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    Stroke volume and cardiac output

    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

  • DevicePacing

    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%)

05

What researchers measure

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)

    Time frame: 1 day

Secondary outcomes

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

    Change in Cardiac output at ventricular (VVI) paced rates when it is lower (50-70 bpm) and higher (130 bpm) while supine

    Time frame: 1 day

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

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

    Time frame: 1 day

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

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

    Time frame: 1 day

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

    Change in stroke volume at lower (50-70 bpm) vs. higher (130 bpm) atrial paced rates while tilted up

    Time frame: 1 day

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

    Change in stroke volume at ventricular (VVI) paced rates when it is lower (50-70 bpm) and higher (130 bpm) while tilted up

    Time frame: 1 day

  6. Change of stroke volume at lower and higher atrial (AAI) paced rates while supine versus while upright

    Change of stroke volume at lower and higher atrial (AAI) paced rates while supine versus while upright at different paced rates

    Time frame: 1 day

  7. Change of stroke volume at lower and higher ventricular (VVI) paced rates while supine versus while upright

    Change of stroke volume at lower and higher ventricular (VVI) paced rates while supine versus while upright at different paced rates

    Time frame: 1 day

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03446326
Lead sponsor
University of Calgary
Responsible party
Sponsor
First posted
Feb 26, 2018
Start date
Jan 1, 2018
Primary completion
Jan 1, 2027 (estimated)
Completion
Jan 1, 2028 (estimated)
Last update
May 5, 2026

Study contacts

Satish R Raj, MD MSCI
Contact
satish.raj@ucalgary.ca
4032106152
Satish R Raj, MD MSCI
principal investigator · University of Calgary

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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