New pacemaker for heart failure patients after bypass surgery
Respiratory Sinus Arrhythmia Pacing Post-CABG Surgery in Patients With HFrEF
This study is testing a new type of pacemaker to see if it can help heart failure patients feel better after they have heart surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Ceryx Medical Ltd Industry-sponsored |
| Locations | 1 site (Cardiff) |
| Trial ID | NCT06359938 on ClinicalTrials.gov |
What this trial studies
This clinical trial tests a novel pacemaker designed to restore respiratory sinus arrhythmia (RSA) in patients with heart failure and reduced ejection fraction (HFrEF) following coronary artery bypass graft (CABG) surgery. The study employs a randomized controlled trial design, comparing RSA-modulated atrial pacing to standard monotonic atrial pacing. Participants will undergo various assessments before and after surgery, with close monitoring during their recovery. The primary focus is to evaluate the safety and effectiveness of the new pacing method in improving cardiac function.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22 and older with HFrEF scheduled for isolated CABG surgery.
Not a fit: Patients requiring concurrent valve replacement surgery or those with a history of certain arrhythmias may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance heart function and overall recovery in heart failure patients post-surgery.
How similar studies have performed: While this approach is novel, prior animal studies suggest potential benefits, but human trials of this specific method are untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (≥ 22 years) selected for isolated, on-pump coronary artery bypass graft (CABG) * Established diagnosis of heart failure with reduced ejection fraction (HFrEF). * Elective or urgent admission routes * Echocardiography assessment of left ventricular ejection fraction (EF) of 20%-40% (within 1 month of planned surgery) * Sinus rhythm * Any number of coronary vessels replaced. Must include left anterior descending artery. * Able to provide written informed consent Exclusion Criteria: * Requirement for concurrent valve replacement surgery. * Off-pump CABG. * Emergency CABG * History of paroxysmal or permanent atrial fibrillation or flutter * History of atrioventricular-node dependent tachycardia * Patients lacking capacity to consent * Patient testing positive for Covid-19 within 14 days of intended CABG (PCR or lateral flow test) * Intrinsic resting heart rate \> 100bpm * Pregnancy * Implanted pacemaker or defibrillator * Failure to obtain Uscom signals
Where this trial is running
Cardiff
- Cardiff & Vale University Health Board — Cardiff, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Zaheer Yousef — Cardiff and Vale University Health Board
- Study coordinator: Susan Peirce, PhD
- Email: susan.peirce@wales.nhs.uk
- Phone: +44 (0)29 218 44771
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.