Actively Recruiting
Optimal Pacing Rate for Cardiac Resynchronization Therapy
Led by Medstar Health Research Institute · Updated on 2024-10-15
60
Participants Needed
5
Research Sites
84 weeks
Total Duration
On this page
Sponsors
M
Medstar Health Research Institute
Lead Sponsor
M
Medtronic
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Optimal Pacing Rate for Cardiac Resynchronization Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- History of persistent or permanent atrial fibrillation
- Received CRT or conduction system pacing implantation within 3 months to 5 years before study start
- History of intrinsic AV node block or AV node ablation within 3 months to 5 years before study start
- Left ventricular ejection fraction (LVEF) of 50% or higher
- N-terminal pro-B-type natriuretic peptide (NT-proBNP) level greater than 400 pg/mL in the last 24 months
- Clinical diagnosis of heart failure or New York Heart Association (NYHA) class II or higher
- Able to provide informed consent
You will not qualify if you...
- Left ventricular ejection fraction (LVEF) less than 50%
- Wide QRS duration greater than 150 milliseconds
- Isolated right ventricular pacing
- Severe valvular heart disease
- Severe coronary artery disease including:
- Acute coronary syndrome or percutaneous coronary intervention within 1 year
- Any angina (Canadian Cardiovascular Society class 1 or higher)
- Severe unrevascularizable coronary artery disease with over 70% stenosis in one or more major vessels
- End-stage renal disease
- Significant primary lung disease requiring home oxygen
- Major orthopedic issues such as wheelchair dependence or inability to perform the six-minute walk test
- More than 15% premature ventricular contractions (ventricular ectopy)
- End-stage cancer diagnosis
- Life expectancy less than one year
- Receiving palliative or hospice care
- Hypertrophic cardiomyopathy
- Uncorrected ventricular septal defect
- Infiltrative cardiomyopathy
- Uncontrolled hypertension with blood pressure over 160/100 mm Hg on two measurements at least 15 minutes apart
- Hemoglobin level less than 7 g/dL
- Age over 90 years
- Pregnant or planning to become pregnant
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
2
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
3
MedStar Union Memorial Hospital
Baltimore, Maryland, United States, 21218
Not Yet Recruiting
4
MedStar Southern Maryland Hospital
Clinton, Maryland, United States, 20735
Actively Recruiting
5
MedStar Heart and Vascular Office at Fairfax
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
S
Sarahfaye Dolman
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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