General Information
Age Group
AdultsStatus
RecruitingProtocol Number
NCT05650658
Background Information
This trial evaluates the effects of His or left bundle branch pacing (LBBP) comparative to biventricular pacing on quality of life, exercise capacity, hospitalization for heart failure, and mortality in patients with HF and conduction system disease.
For more information, please visit: https://clinicaltrials.gov/study/NCT0565065
Offered At
Inova Fairfax Medical Center
3300 Gallows Rd
Falls Church, VA, 22042
Principal Investigator
Eligibility Information
- 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%; and - 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 prior to implantation procedure.
Ineligibility Information
- 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 next three (3) months;
- 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 severe valvular disease (e.g., aortic stenosis);
- Participants with irreversible brain damage from preexisting cerebral disease.