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.
Cardiac resynchronization therapy (CRT) after atrioventricular node (AVN) ablation for permanent atrial fibrillation (AF) has led to better outcomes in heart failure (HF) patients with reduced ejection fraction (HFrEF) and with preserved ejection fraction (HFpEF) compared to pharmacotherapy. Emerging evidence has demonstrated patients with HFpEF may benefit from a higher heart rate compared to standard heart-lowering therapies. The optimal pacing rate for CRT after AVN ablation in persistent AF and HFpEF remains unknown. 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. Patient mortality and HF hospitalizations will be recorded at each phase. An electrocardiogram, echocardiogram, pacemaker interrogation, BNP and creatinine levels, KCCQ-12, six-minute walk test, and physical activity measure will be obtained at baseline, 3 months, and 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Pacing rate of 80 bpm
Pacing rate of 60 bpm
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
RECRUITINGMedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
RECRUITINGMedStar Union Memorial Hospital
Baltimore, Maryland, United States
Exercise tolerance as measured by the Six-Minute Walk Test
Exercise tolerance as measured by the Six-Minute Walk Test
Time frame: 3 months
Quality of life as measured by the Kansas City Cardiomyopathy Questionnaire
Quality of life as measured by the Kansas City Cardiomyopathy Questionnaire
Time frame: 3 months
Function as measured by the International Physical Activity Questionnaire
Function as measured by the International Physical Activity Questionnaire
Time frame: 3 months
Change in B-type natriuretic peptide (BNP)
Change in B-type natriuretic peptide (BNP)
Time frame: 3 months
Change in creatinine
Change in creatinine
Time frame: 3 months
Change in New York Heart Association Class
Change in New York Heart Association Class
Time frame: 3 months
Atrial fibrillation burden
Atrial fibrillation burden as measured by pacemaker
Time frame: 3 months
Hospitalization for heart failure
Hospitalization for heart failure
Time frame: 3 months
Death due to heart failure
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MedStar Southern Maryland Hospital
Clinton, Maryland, United States
RECRUITINGMedStar Heart and Vascular Office at Fairfax
Fairfax, Virginia, United States
RECRUITINGDeath due to heart failure
Time frame: 3 months
Death due to myocardial infarction
Death due to myocardial infarction
Time frame: 3 months
Death due to stroke
Death due to stroke
Time frame: 3 months
Hospitalization for atrial fibrillation
Hospitalization for atrial fibrillation
Time frame: 3 months
Administration of loop diuretic/anti-arrhythmic drug
Administration of loop diuretic/anti-arrhythmic drug
Time frame: 3 months