Recruiting

Pacing Rate

Sponsor:

Medstar Health Research Institute

Code:

NCT06445439

Conditions

Atrial Fibrillation, Persistent

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Pacing rate of 80 bpm

Pacing rate of 60 bpm

Study Details

Brief 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.

Conditions

Atrial Fibrillation, Persistent

Study ID

NCT06445439

Start date

Dec 19, 2023

Status verified date

Aug, 2024

Completion date

Aug, 2025

Anticipated

Primary completion date

Aug, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not 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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 60 bpm, then 80 bpm

Pacing rate of 60 bpm for the first 3 months, then switch to 80 bpm for the next 3 months.

experimental: 80 bpm, then 60 bpm

Pacing rate of 80 bpm for the first 3 months, then switch to 60 bpm for the next 3 months.

Interventions

Pacing rate of 80 bpm

Pacing rate of 80 bpm

Pacing rate of 60 bpm

Pacing rate of 60 bpm

Primary outcome measure

  • Exercise tolerance as measured by the Six-Minute Walk Test [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Locations

MedStar Georgetown University Hospital

Recruiting

Washington, District of Columbia, United States, 20007

Contacts

MedStar Washington Hospital Center

Recruiting

Washington, District of Columbia, United States, 20010

Contacts

MedStar Southern Maryland Hospital

Recruiting

Clinton, Maryland, United States, 20735

Contacts

MedStar Heart and Vascular Office at Fairfax

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

More Information

Sponsor

Medstar Health Research Institute

Last update posted

Oct 15, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medstar Health Research Institute on 2024-10-15.