Optimal Pacing Rate for Cardiac Resynchronization Therapy

Description

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.

Conditions

Atrial Fibrillation, Persistent

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Study Overview

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Study Details

Study overview

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.

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

Optimal Pacing Rate for Cardiac Resynchronization Therapy

Condition
Atrial Fibrillation, Persistent
Intervention / Treatment

-

Contacts and Locations

Washington

MedStar Georgetown University Hospital, Washington, District of Columbia, United States, 20007

Washington

MedStar Washington Hospital Center, Washington, District of Columbia, United States, 20010

Baltimore

MedStar Union Memorial Hospital, Baltimore, Maryland, United States, 21218

Clinton

MedStar Southern Maryland Hospital, Clinton, Maryland, United States, 20735

Fairfax

MedStar Heart and Vascular Office at Fairfax, Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to 90 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medstar Health Research Institute,

Athanasios Thomaides, MD, PRINCIPAL_INVESTIGATOR, MedStar Health

Study Record Dates

2025-08