An interventional study of Conduction system pacing and Biventricular pacing in Heart Failure, Left Bundle-Branch Block and Cardiac Resynchronization, sponsored by Hospital Moinhos de Vento. Completed at 14 sites in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-08.
Sponsored by Hospital Moinhos de Vento · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of conduction system pacing versus biventricular pacing in patients with chronic heart failure with reduced ejection fraction and left bundle branch block.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's enrollment of 179 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Hospital Moinhos de Vento is the lead sponsor of 34 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will be randomized 1:1 to either conduction system pacing or biventricular pacing.
Device: Conduction system pacing
Patients will be randomized 1:1 to either conduction system pacing or biventricular pacing.
Device: Biventricular pacing
Pacing from the His-Purkinje system (His-bundle pacing, left bundle branch area pacing, or deep septal pacing).
Pacing from the coronary sinus and right ventricular leads.
Primary Outcome Measure
Heart failure-related net composite outcome, a hierarchical composite of all-cause death, any hospitalization for heart failure, any urgent heart failure visit, and left ventricular ejection fraction change at 12 months. The category of the composite outcome for each patient will be determined by assessing the following criteria sequentially, stopping when the event is present: All-cause death: death during follow-up. Hospitalization for heart failure: any hospitalization for heart failure during follow-up. Urgent heart failure visit: any urgent heart failure visit during follow-up. Left ventricular ejection fraction change: the difference between baseline and follow-up, categorized by every 5-point change. The distribution of outcome categories will be compared by ordinal distribution analysis. Non-inferiority margin: odds ratio \<1.2.
Time frame: 12 months
Key secondary outcome: Cost analysis (dominance) (superiority)
Mean total direct medical cost per patient at 12 months.
Time frame: 12 months
Change in QRS complex
Time frame: Duration of the QRS complex, defined as the widest paced QRS complex rated at 12-lead ECG, measured immediately after the index procedure
Change in left ventricular ejection fraction
Time frame: 12 months
Left ventricular end-diastolic volume
Time frame: 12 months
Change in natriuretic peptide values
BNP and NT-proBNP
Time frame: 12 months
Change in 6-minute walk test
Time frame: 12 months
Change in NYHA Classification
New York Heart Association Functional Class
Time frame: 12 months
Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score
The Kansas City Cardiomyopathy Questionnaire Overall Summary Score ranges from 0-100, where a lower score indicates a worse outcome.
Time frame: 12 months
EuroQol Group 5-Dimensions questionnaire (EQ-5D)
Time frame: 12 months
Hierarchical endpoint of death, hospitalization for heart failure, urgent heart failure visit, and change in KCCQ Clinical Summary Score
Time frame: 12 months
Change in peak oxygen consumption (VO2)
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Hospital Moinhos de Vento