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Compares treatment options for Cardiac Resynchronization Therapy
Official title Conduction System Pacing vs Biventricular Pacing in Systolic Dysfunction and Wide QRS: Mortality, Heart Failure Hospitalization or Cardiac Transplant
ClinicalTrials.gov ID: NCT06105580
What this study is testing
- What it's testing
- Conduction system pacing vs biventricular resynchronization therapy in systolic dysfunction and wide QRS: mortality, heart failure hospitalization or cardiac transplant (CONSYST-CRT II trial). Superiority trial that aims to study the composite endpoint consisting of all-cause mortality, cardiac transplant or heart failure hospitalization at 12-month follow-up.
- Time commitment: about 12 months
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
- Patient must indicate acceptance to participate in the study by signing an informed consent document.
- Patient must be ≥ 18 years of age.
- Left bundle branch block, QRS ≥130 and LVEF \<=35%. No indication of stimulation for AV block.
- Non-left bundle branch block, QRS ≥150 and LVEF \<=35%.
- Resynchronization therapy indication for ventricular dysfunction (LVEF \<40%) and indication of cardiac pacing for AV block.
You likely can't join if
- Myocardial infarction, unstable angina or cardiac revascularization during the previous 3 months.
- Pregnancy.
- Participating currently in a clinical investigation that includes an active treatment.
See the full eligibility criteria
- Patient must indicate acceptance to participate in the study by signing an informed consent document.
- Patient must be ≥ 18 years of age.
- Left bundle branch block, QRS ≥130 and LVEF \<=35%. No indication of stimulation for AV block.
- Non-left bundle branch block, QRS ≥150 and LVEF \<=35%.
- Resynchronization therapy indication for ventricular dysfunction (LVEF \<40%) and indication of cardiac pacing for AV block.
- LVEF \ =130 ms, provided a strategy to ensure biventricular capture is in place.
- Myocardial infarction, unstable angina or cardiac revascularization during the previous 3 months.
- Pregnancy.
- Participating currently in a clinical investigation that includes an active treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Spain
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 study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Barcelona, Spain. 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.