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Device

Pacing for Fainting (Pacing_SV Trial)

N/A

Recruiting

Led By Satish R Raj, MD MSCI

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-70 years (inclusive)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 day

Awards & highlights

Pacing_SV Trial Summary

This trial will study how different heart rates affect stroke volume and cardiac output, using pacemaker patients as subjects.

Who is the study for?

This trial is for adults aged 18-70 with a healthy heart pump function (LV ejection fraction >50%) who already have a permanent pacemaker or defibrillator that can control heartbeats. It's not suitable for those who can't consent or need a specific cardiac device.Check my eligibility

What is being tested?

The study aims to understand how different heart rates affect the amount of blood pumped by the heart each beat and overall circulation, using non-invasive methods in patients with devices that can safely adjust their heartbeat.See study design

What are the potential side effects?

Since this trial involves adjusting pacemakers or defibrillators, side effects may include discomfort from changes in heartbeat but no drug-related side effects are expected as it doesn't involve medication.

Pacing_SV Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 70 years old.

Pacing_SV Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 day

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 day

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

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

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

+4 more

Pacing_SV Trial Design

1Treatment groups

Experimental Treatment

Group I: Stroke volume and cardiac outputExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pacing

2019

Completed Phase 2

~90

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor

792 Previous Clinical Trials

869,129 Total Patients Enrolled

4 Trials studying Vasovagal Syncope

359 Patients Enrolled for Vasovagal Syncope

Satish R Raj, MD MSCIPrincipal InvestigatorUniversity of Calgary

19 Previous Clinical Trials

1,401 Total Patients Enrolled

1 Trials studying Vasovagal Syncope

57 Patients Enrolled for Vasovagal Syncope

Media Library

Permanent Pacemaker (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03446326 — N/A

Vasovagal Syncope Research Study Groups: Stroke volume and cardiac output

Vasovagal Syncope Clinical Trial 2023: Permanent Pacemaker Highlights & Side Effects. Trial Name: NCT03446326 — N/A

Permanent Pacemaker (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03446326 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly individuals eligible to participate in this investigation?

"According to the study requirements, only individuals aged 18-70 are eligible for recruitment. For those younger or older than this range, there is 9 and 18 trials respectively that they may be able to join."

Answered by AI

Are there still opportunities to join this research program?

"Per clinicaltrials.gov, this trial is actively seeking suitable candidates for participation. The study was initially shared on January 1st 2018 and the most recent modification occurred on February 7th 2022."

Answered by AI

What are the criteria for enrolling in this scientific experiment?

"To be considered for this clinical trial, applicants must be diagnosed with vasovagal syncope and situated within the demographic range of 18-70 years. 25 patients are needed to complete the study's enrolment process."

Answered by AI

How many participants are being welcomed into this experimental program?

"Affirmative. Clinicaltrials.gov indicates that this investigation, initially posted on the first of January 2018, is actively recruiting participants. 25 individuals are sought after to be enrolled from a single medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2018. "Assessment of Stroke Volume and Cardiac Output in Response to Varying Heart Rates". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03446326.