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New treatment option for Right Bundle-Branch Block
Official title His-Bundle Corrective Pacing in Heart Failure
ClinicalTrials.gov ID: NCT05265520
What this study is testing
- What it's testing
- The investigators aim to prospectively evaluate the efficacy and mechanism of benefit of His-bundle pacing enhanced cardiac resynchronization therapy (His-CRT) vs. cardiac resynchronization therapy (BIV-CRT) in patients with heart failure and right bundle branch block (RBBB).
- 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 and older
You may be able to join if
- Age 18 years or older (no upper age limit)
- Optimal medical therapy for heart failure by current guidelines
- Class IIa or IIb guideline-based indication for CRT-D implant in RBBB patients, including one of the following:
- New York Heart Association (NYHA) class II HF symptoms, LVEF ≤ 30% and QRS≥ 150 ms (IIb); OR
- NYHA class III-IV a HF, LVEF ≤ 35%, and QRS duration ≥ 150 ms (IIa); OR
You likely can't join if
- Unable to obtain most recent imaging data from echocardiogram within 1 year prior to date of randomization
- Left bundle branch block (LBBB) or intraventricular conduction delay (IVCD) ECG morphology
- Unable or unwilling to follow study protocol
- Less than 12 months life expectancy at consent
- Pregnancy or planned pregnancy during duration of the study
- On heart transplant list or likely to undergo heart transplant
See the full eligibility criteria
- Age 18 years or older (no upper age limit)
- Optimal medical therapy for heart failure by current guidelines
- Class IIa or IIb guideline-based indication for CRT-D implant in RBBB patients, including one of the following:
- New York Heart Association (NYHA) class II HF symptoms, LVEF ≤ 30% and QRS≥ 150 ms (IIb); OR
- NYHA class III-IV a HF, LVEF ≤ 35%, and QRS duration ≥ 150 ms (IIa); OR
- NYHA class III-IV a HF, LVEF ≤ 35%, and QRS duration 120-149 ms (IIb)
- Unable to obtain most recent imaging data from echocardiogram within 1 year prior to date of randomization
- Left bundle branch block (LBBB) or intraventricular conduction delay (IVCD) ECG morphology
- Unable or unwilling to follow study protocol
- Less than 12 months life expectancy at consent
- Pregnancy or planned pregnancy during duration of the study
- On heart transplant list or likely to undergo heart transplant
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Ridgewood, New Jersey, United States
- New York, New York, United States
- Asheville, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Wilkes-Barre, Pennsylvania, United States
- Burlington, Vermont, United States
- Richmond, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Los Angeles, California, United States; Tampa, Florida, United States; Chicago, Illinois, United States; Ridgewood, New Jersey, United States; New York, New York, United States and 5 more location(s). 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.