Heart Failure study: His/LBBP vs BiVP
Official title Left vs Left Randomized Clinical Trial
ClinicalTrials.gov ID: NCT05650658
What this study is testing
- What it's testing
- The study compares how well His or left bundle branch pacing works for heart failure patients versus the usual biventricular pacing, looking at quality of life, activity, hospital visits, and death.
- Who it's for
- Adults with heart failure and reduced heart pumping ability (LVEF ≤50%) who have a wide QRS or are expected to use pacing more than 40% of the time and are already on standard heart‑failure medication.
- What's involved
- Participants will receive either His or left bundle branch pacing and will have regular follow‑up visits and tests to monitor heart function and any device problems.
- Time commitment
- The trial lasts until the final follow‑up visit, with several scheduled visits for device checks and health assessments.
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
- Men and women 18 years of age or older.
- A LVEF ≤ 50% within 6 months prior to enrollment.
- Resting QRS duration ≥130 ms as evidenced by a historical 12-lead ECG prior to enrollment OR anticipated right ventricular pacing \>40% OR device in...
- Are optimized on HF guideline directed medical therapy according to current HF published guidelines OR patient's physician will make an effort to...
You likely can't join if
- Women who are pregnant, lactating, or plan to become pregnant during the course of the trial.
- Participants with angiographic evidence of coronary disease who are candidates for coronary revascularization and are likely to undergo coronary...
- Enzyme-positive myocardial infarction within the past three (3) months prior to enrollment.
- Coronary artery bypass graft surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within the past three (3) months prior...
- Reversible non-ischemic cardiomyopathy (e.g., acute viral myocarditis).
- Participants with Chagas disease, cardiac sarcoidosis or amyloidosis.
See the full eligibility criteria
- Men and women 18 years of age or older.
- A LVEF ≤ 50% within 6 months prior to enrollment.
- Resting QRS duration ≥130 ms as evidenced by a historical 12-lead ECG prior to enrollment OR anticipated right ventricular pacing \>40% OR device in place with right ventricular pacing \> 40%.
- Are optimized on HF guideline directed medical therapy according to current HF published guidelines OR patient's physician will make an effort to start all guideline-directed medical therapy and titrate doses up as...
- Women who are pregnant, lactating, or plan to become pregnant during the course of the trial.
- Participants with angiographic evidence of coronary disease who are candidates for coronary revascularization and are likely to undergo coronary artery bypass graft surgery or percutaneous coronary, intervention in the...
- Enzyme-positive myocardial infarction within the past three (3) months prior to enrollment.
- Coronary artery bypass graft surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within the past three (3) months prior to enrollment.
- Reversible non-ischemic cardiomyopathy (e.g., acute viral myocarditis).
- Participants with Chagas disease, cardiac sarcoidosis or amyloidosis.
- Expected to receive left ventricular assist device or heart transplantation within 6 months.
- Participants with primary severe valvular disease (e.g., aortic stenosis).
- Have a life expectancy of less than 12 months.
- Participants with irreversible brain damage from preexisting cerebral disease.
- Participants with a contrast dye allergy unable or unwilling to undergo pretreatment with steroids and/or diphenhydramine.
- Participants participating in any other treatment cardiovascular clinical trial.
- Participants who would be unable to comply with the study's follow-up visit schedule; or
- Participants who had any prior unsuccessful attempt at implantation of biventricular pacing (BiVP), His Bundle Pacing (HBP), or Left Bundle Branch Pacing (LBBP) device.
The study team makes the final eligibility decision.
Where it is enrolling
- Gilbert, Arizona, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- La Jolla, California, United States
- Denver, Colorado, United States
- Littleton, Colorado, United States
- Hartford, Connecticut, United States
- New Haven, Connecticut, United States
- Davie, Florida, United States
- Jacksonville, Florida, United States
- Palm Beach Gardens, Florida, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Evanston, Illinois, United States
- Indianapolis, Indiana, United States
- Louisville, Kentucky, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- Hackensack, New Jersey, United States
- Marlton, New Jersey, United States
+ 39 more site(s).
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, but 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?
This study is enrolling now at Gilbert, Arizona, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States; La Jolla, California, United States; Denver, Colorado, United States; Littleton, Colorado, United States and 53 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.