Optimal Pacing Rate for Cardiac Resynchronization Therapy
NCT ID: NCT06445439
Last Updated: 2024-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2023-12-19
2025-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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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.
Pacing rate of 80 bpm
Pacing rate of 80 bpm
Pacing rate of 60 bpm
Pacing rate of 60 bpm
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.
Pacing rate of 80 bpm
Pacing rate of 80 bpm
Pacing rate of 60 bpm
Pacing rate of 60 bpm
Interventions
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Pacing rate of 80 bpm
Pacing rate of 80 bpm
Pacing rate of 60 bpm
Pacing rate of 60 bpm
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
90 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Medstar Health Research Institute
OTHER
Responsible Party
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Principal Investigators
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Athanasios Thomaides, MD
Role: PRINCIPAL_INVESTIGATOR
MedStar Health
Locations
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MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
MedStar Union Memorial Hospital
Baltimore, Maryland, United States
MedStar Southern Maryland Hospital
Clinton, Maryland, United States
MedStar Heart and Vascular Office at Fairfax
Fairfax, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Athanasios Thomaides, MD
Role: backup
Athanasios Thomaides, MD
Role: backup
Athanasios Thomaides, MD
Role: backup
Athanasios Thomaides, MD
Role: backup
Athanasios Thomaides, MD
Role: backup
Other Identifiers
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STUDY00006952
Identifier Type: -
Identifier Source: org_study_id
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