RECRUITING

Optimal Pacing Rate for Cardiac Resynchronization Therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-12-19

Study Completion:2025-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06445439

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.

Ages Eligible for Study:18 Years to 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Sarahfaye Dolman

CONTACT

302-530-1873

Sarahfaye.F.Dolman@medstar.net

Principal Investigator

Athanasios Thomaides, MD

PRINCIPAL_INVESTIGATOR

MedStar Health

Study Locations (Sites)

MedStar Georgetown University Hospital

Washington, District of Columbia, 20007

United States

MedStar Washington Hospital Center

Washington, District of Columbia, 20010

United States

MedStar Union Memorial Hospital

Baltimore, Maryland, 21218

United States

MedStar Southern Maryland Hospital

Clinton, Maryland, 20735

United States

MedStar Heart and Vascular Office at Fairfax

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: Medstar Health Research Institute

Athanasios Thomaides, MD, PRINCIPAL_INVESTIGATOR, MedStar Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-19

Study Completion Date2025-08

Study Record Updates

Study Start Date2023-12-19

Study Completion Date2025-08

Terms related to this study

Additional Relevant MeSH Terms

Atrial Fibrillation, Persistent