Optimal Pacing Rate for Cardiac Resynchronization Therapy

Recruiting now · Not applicable

Conditions studied: Atrial Fibrillation, Persistent

In brief

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.

Key facts

Study ID

NCT06445439

Run by

Medstar Health Research Institute

People needed

60

Starts

2023-12-19

Expected to finish

2025-08-01

Last updated by the study team

2024-10-15

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States (enrolling)
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States (enrolling)
• MedStar Southern Maryland Hospital — Clinton, Maryland, United States (enrolling)
• MedStar Heart and Vascular Office at Fairfax — Fairfax, Virginia, United States (enrolling)
• MedStar Union Memorial Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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