NCT05600725

Novel Cardiac Pacing to Initiate Cardiac Remodeling in Heart Failure

Novel Pacing Modality to Initiate Favorable Cardiac Remodeling in Heart Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Denise Hodgson-Zingman · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This project utilizes a novel cardiac pacing approach hypothesized to initiate beneficial cardiac conditioning and remodeling over a period of time.

Detailed description

The project studies subjects with non-ischemic cardiomyopathy who have a pacing device already implanted. Subjects randomized to the pacing intervention versus a sham intervention will be compared for various symptomatic, functional and other outcomes. Each subject will undergo baseline quality of life/symptom questionnaires and clinical testing for cardiac functional/structural effects and exercise tolerance, then the intervention vs. sham (subjects blinded to their category), followed by repeat questionnaires and clinical testing. Medical record review will be undertaken to establish demographic variables, baseline and follow up testing results.

Conditions

• Cardiomyopathies
• Heart Rate
• Conditioning

Interventions

Type	Name	Description
OTHER	novel atrial pacing approach	See US Patent #10987516. An atrial pacing method that preserves atrioventricular and interventricular synchrony to reproduce an exercise-typical envelope of heart rate.
OTHER	sham pacing approach	A pacemaker/ICD interrogator/programmer will be used to simulate changes in pacing rate over the same time period as the intervention group but the programming changes will not actually be implemented and not change in paced heart rate will occur.

Timeline

• Start date: 2022-11-02
• Primary completion: 2023-02-28
• Completion: 2023-02-28
• First posted: 2022-10-31
• Last updated: 2023-05-16

Locations

1 site across 1 country: United States