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Optimal Pacing Rate for Cardiac Resynchronization Therapy
RECRUITINGN/ASponsored by Medstar Health Research Institute
Actively Recruiting
PhaseN/A
SponsorMedstar Health Research Institute
Started2023-12-19
Est. completion2025-08
Eligibility
Age18 Years – 90 Years
Healthy vol.Accepted
Locations5 sites
View on ClinicalTrials.gov →
NCT06445439
Summary
This is a prospective, randomized crossover study. The objective of the study is to determine if a pacing rate of 80 beats per minute (bpm) improves exercise tolerance during the 6-minute walk test. The investigators will randomly assign half of the participants to a starting rate of 60 bpm and then switch them to a rate of 80 bpm for 3 months, and vice versa.
Eligibility
Age: 18 Years – 90 YearsHealthy volunteers accepted
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
Conditions2
Atrial Fibrillation, PersistentHeart Disease
Locations5 sites
District of Columbia
2 sitesMedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Maryland
2 sitesMedStar Union Memorial Hospital
Baltimore, Maryland, 21218
MedStar Southern Maryland Hospital
Clinton, Maryland, 20735
Virginia
1 siteMedStar Heart and Vascular Office at Fairfax
Fairfax, Virginia, 22031
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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
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Actively Recruiting
PhaseN/A
SponsorMedstar Health Research Institute
Started2023-12-19
Est. completion2025-08
Eligibility
Age18 Years – 90 Years
Healthy vol.Accepted
Locations5 sites
View on ClinicalTrials.gov →
NCT06445439