RecruitingNot ApplicableNCT06445439

Optimal Pacing Rate for Cardiac Resynchronization Therapy

Optimal Pacing Rate for Cardiac Resynchronization Therapy After Atrioventricular Node Ablation in Persistent Atrial Fibrillation and Heart Failure

Sponsor

Medstar Health Research Institute

Enrollment

60 participants

Start Date

Dec 19, 2023

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation, Persistent

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

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria8

Age 18 years or older
History of persistent or permanent atrial fibrillation
Implantation of CRT or conduction system pacing in prior 3 months to 5 years of study start
History of intrinsic AVN block or have undergone AVN ablation in prior 3 months to 5 years of study start
LVEF ≥ 50%
N-terminal pro-B-type natriuretic peptide (NT-proBNP) \>400 pg/mL in the last 24 months
Clinical HF diagnosis or NYHA class II or higher
Able to provide informed consent

Exclusion Criteria22

LVEF \<50%
Wide QRS (greater than 150ms)
Isolated RV pacing
Severe valvular disease
Severe coronary artery disease as defined by one of the following:
ACS or PCI within 1 year
Any angina (CCS class 1+)
Unrevascularizable severe CAD (\>70% stenosis in 1+ major vessels and/or based on functional assessment)
ESRD
Significant primary pulmonary disease on home oxygen
Major orthopedic issues, such as being wheelchair bound and/or unable to perform a six-minute walk test
Ventricular ectopy \>15% premature ventricular contractions (PVC)
End stage cancer diagnosis
Life expectancy less than one year
Palliative or hospice care
Hypertrophic cardiomyopathy (HCM)
Uncorrected ventricular septal defect
Infiltrative cardiomyopathy (CM)
Uncontrolled hypertension as defined by blood pressure \>160/100 mm Hg on two measurements ≥15 minutes apart
Hemoglobin \<7 g/dL
Age \>90 years old
Pregnant or intends to become pregnant