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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
Must not have
Clinical need for a cardiac resynchronization device
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights
No Placebo-Only Group
Summary
This trial will change the heart rates of patients with pacemakers to see how it affects the amount of blood their hearts pump. Researchers want to understand if faster heartbeats give the heart less time to fill with blood, which might affect its efficiency.
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 70 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need a device to help my heart beat in sync.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in cardiac output while atrial pacing at lower and higher rates while supine
Secondary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Vasovagal Syncope, such as pacemaker adjustments, work by stabilizing heart rate and blood pressure to prevent the sudden drops that cause fainting. Pacemakers can be programmed to maintain a minimum heart rate or limit ventricular pacing, ensuring consistent cardiovascular function.
This is important for Vasovagal Syncope patients as it helps prevent the episodes of syncope by maintaining stable heart function.
Stop vasodepressor drugs in reflex syncope: a randomised controlled trial.
Stop vasodepressor drugs in reflex syncope: a randomised controlled trial.
Find a Location
Who is running the clinical trial?
University of CalgaryLead Sponsor
810 Previous Clinical Trials
886,269 Total Patients Enrolled
Satish R Raj, MD MSCIPrincipal InvestigatorUniversity of Calgary
19 Previous Clinical Trials
1,401 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Criterion: Your heart's pumping ability is normal.You have a permanent pacemaker or defibrillator implanted in your body.I am between 18 and 70 years old.I need a device to help my heart beat in sync.
Research Study Groups:
This trial has the following groups:- Group 1: Stroke volume and cardiac output
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.