BridgeMD
New treatment option for Atrial Fibrillation, Persistent
Official title Optimal Pacing Rate for Cardiac Resynchronization Therapy
ClinicalTrials.gov ID: NCT06445439
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- Age 18 years or older
- History of persistent or permanent atrial fibrillation
- Implantation of CRT or conduction system pacing in prior 3 months to 5 years of study start
- History of intrinsic AVN block or have undergone AVN ablation in prior 3 months to 5 years of study start
- LVEF ≥ 50%
You likely can't join if
- LVEF \<50%
- Wide QRS (greater than 150ms)
- Isolated RV pacing
- Severe valvular disease
- Severe coronary artery disease as defined by one of the following:
- ACS or PCI within 1 year
See the full eligibility criteria
- Age 18 years or older
- History of persistent or permanent atrial fibrillation
- Implantation of CRT or conduction system pacing in prior 3 months to 5 years of study start
- History of intrinsic AVN block or have undergone AVN ablation in prior 3 months to 5 years of study start
- LVEF ≥ 50%
- N-terminal pro-B-type natriuretic peptide (NT-proBNP) \>400 pg/mL in the last 24 months
- Clinical HF diagnosis or NYHA class II or higher
- Able to provide informed consent
- LVEF \<50%
- Wide QRS (greater than 150ms)
- Isolated RV pacing
- Severe valvular disease
- Severe coronary artery disease as defined by one of the following:
- ACS or PCI within 1 year
- Any angina (CCS class 1+)
- Unrevascularizable severe CAD (\>70% stenosis in 1+ major vessels and/or based on functional assessment)
- ESRD
- Significant primary pulmonary disease on home oxygen
- Major orthopedic issues, such as being wheelchair bound and/or unable to perform a six-minute walk test
- Ventricular ectopy \>15% premature ventricular contractions (PVC)
- End stage cancer diagnosis
- Life expectancy less than one year
- Palliative or hospice care
- Hypertrophic cardiomyopathy (HCM)
- Uncorrected ventricular septal defect
- Infiltrative cardiomyopathy (CM)
- Uncontrolled hypertension as defined by blood pressure \>160/100 mm Hg on two measurements ≥15 minutes apart
- Hemoglobin \<7 g/dL
- Age \>90 years old
- Pregnant or intends to become pregnant
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
- Baltimore, Maryland, United States
- Clinton, Maryland, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States; Baltimore, Maryland, United States; Clinton, Maryland, United States; Fairfax, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.