Augmented Pacing for Bradycardia

Overseen By Jonah D Garry, M.D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Single chamber ICD, Ventricular tachycardia, Hemodynamic instability, Mechanical support, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

25 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since participants must be receiving a vasopressor or inotrope, it seems likely that some medications will continue.

What data supports the effectiveness of the treatment Backup Pacing Rate Change for bradycardia?

Research suggests that using rate adaptive pacemakers, which adjust pacing based on the body's needs, can improve heart function in patients with bradycardia (slow heart rate). These devices help maintain a more natural heart rhythm and improve exercise capacity, which may support the effectiveness of Backup Pacing Rate Change. ^{1 2 3 4 5}

Is augmented pacing for bradycardia safe for humans?

The studies suggest that while pacing treatments for bradycardia are generally safe, they can sometimes lead to other heart rhythm issues, like tachyarrhythmias (fast heart rhythms). Careful monitoring and adjustments, such as changing medications or pacemaker settings, can help manage these risks. ^{1 6 7 8 9}

What is the purpose of this trial?

The goal of this clinical trial is to learn if backup pacing at an increased rate improves hemodynamics in adults with relative bradycardia, a permanent pacemaker, and cardiogenic shock. The main question it aims to answer is: Does increasing the backup pacing rate to 100 beats per minute lead to improved cardiac index compared to a backup pacing rate of 75 beats per minute Participants who are already hospitalized in the Cardiovascular Intensive Care Unit with a permanent pacemaker and pulmonary artery catheter in place will be enrolled in this study. Participants will be exposed to each pacemaker rate in a randomized order with hemodynamics assessed after 10 minutes at each rate.

Eligibility Criteria

This trial is for adults over 18 in the Cardiovascular Intensive Care Unit (CVICU) with a permanent pacemaker and slow heart rate, who are on specific heart medications for at least 4 hours. They must have a special catheter placed to measure heart function and an average heart rate of 75 bpm or less.

Inclusion Criteria

I have a pacemaker or ICD that can be set to 100 bpm.

I have been on medication to support my heart or blood pressure for at least 4 hours.

My average heart rate has been 75 bpm or less in the last hour.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants are exposed to each pacemaker rate in a randomized order with hemodynamics assessed after 10 minutes at each rate

1 day

In-hospital

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Backup Pacing Rate Change

Trial Overview The study tests if increasing the backup pacing rate of a pacemaker to 100 beats per minute can improve heart function compared to the usual setting of 75 beats per minute in patients with cardiogenic shock and relative bradycardia.

Participant Groups

Group I: Standard Pacing (75 bpm) then Augmented Pacing (100 bpm) Experimental Treatment 1 Intervention

Backup pacing rate will be set to 75 bpm first then 100 bpm second

Group II: Augmented Pacing Rate (100 bpm) then Standard Pacing (75 bpm) Experimental Treatment 1 Intervention

Backup pacing rate will be set to 100 bpm first then 75 bpm second

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Atrial arrhythmia management with sensor controlled atrial refractory period and automatic mode switching in patients with minute ventilation sensing dual chamber rate adaptive pacemakers. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Modelling the health benefits and economic implications of implanting dual-chamber vs. single-chamber ventricular pacemakers in the UK. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Physiological pacing: present status and future developments. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical Outcomes of Various Management Strategies for Symptomatic Bradycardia. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Techniques for improving cardiac performance with implantable devices. [2019]

6. England pubmed.ncbi.nlm.nih.gov

The impact of NICE (UK) recommendations on outcomes of cardiac pacemaker implantations--a single-centre, district hospital experience. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Pace-termination and pacing for prevention of atrial tachyarrhythmias: results from a multicenter study with an implantable device for atrial therapy. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Pacemaker syndrome with AAI rate variable pacing: importance of atrioventricular conduction properties, medication, and pacemaker programmability. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Electrophysiological determinants of arrhythmic susceptibility upon endocardial and epicardial pacing in guinea-pig heart. [2012]