Optimal Pacing Rate for Cardiac Resynchronization Therapy

Launched by MEDSTAR HEALTH RESEARCH INSTITUTE · Jun 3, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether a pacing rate of 80 beats per minute (bpm) can help improve exercise tolerance in patients with persistent atrial fibrillation during a 6-minute walking test. Participants will be randomly assigned to start at either 60 bpm or 80 bpm and will switch to the opposite rate after three months. The goal is to find out which pacing rate helps them walk further and feel better during physical activity.

To be eligible for the study, participants need to be at least 18 years old and have a history of persistent atrial fibrillation. They should also have had a specific type of heart device (called cardiac resynchronization therapy) implanted within the last 3 to 5 years. Other important criteria include having a heart function score that shows they are experiencing heart failure symptoms. Participants will need to commit to follow-up visits and tests to track their progress throughout the study. If you or a loved one meets these criteria, this trial may offer valuable insights into improving heart health and exercise capacity.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 years or older
• • 2. History of persistent or permanent atrial fibrillation
• • 3. Implantation of CRT or conduction system pacing in prior 3 months to 5 years of study start
• • 4. History of intrinsic AVN block or have undergone AVN ablation in prior 3 months to 5 years of study start
• • 5. LVEF ≥ 50%
• • 6. N-terminal pro-B-type natriuretic peptide (NT-proBNP) \>400 pg/mL in the last 24 months
• • 7. Clinical HF diagnosis or NYHA class II or higher
• • 8. Able to provide informed consent
• Exclusion Criteria:
• • 1. LVEF \<50%
• • 2. Wide QRS (greater than 150ms)
• • 3. Isolated RV pacing
• • 4. Severe valvular disease
• 5. Severe coronary artery disease as defined by one of the following:
• • 1. ACS or PCI within 1 year
• • 2. Any angina (CCS class 1+)
• • 3. Unrevascularizable severe CAD (\>70% stenosis in 1+ major vessels and/or based on functional assessment)
• • 6. ESRD
• • 7. Significant primary pulmonary disease on home oxygen
• • 8. Major orthopedic issues, such as being wheelchair bound and/or unable to perform a six-minute walk test
• • 9. Ventricular ectopy \>15% premature ventricular contractions (PVC)
• • 10. End stage cancer diagnosis
• • 11. Life expectancy less than one year
• • 12. Palliative or hospice care
• • 13. Hypertrophic cardiomyopathy (HCM)
• • 14. Uncorrected ventricular septal defect
• • 15. Infiltrative cardiomyopathy (CM)
• • 16. Uncontrolled hypertension as defined by blood pressure \>160/100 mm Hg on two measurements ≥15 minutes apart
• • 17. Hemoglobin \<7 g/dL
• • 18. Age \>90 years old
• • 19. Pregnant or intends to become pregnant