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New treatment option for HCM - Hypertrophic Cardiomyopathy
Official title Left Bundle Branch Pacing in Patients With Hypertrophic Cardiomyopathy After Myectomy
ClinicalTrials.gov ID: NCT07372196
What this study is testing
- What it's testing
- Pilot interventional randomized clinical trial to study the efficacy of left bundle branch pacing in patients with hypertrophic cardiomyopathy after myectomy for the prevention of progression of heart failure, prevent the occurrence of life-threatening rhythm disturbances and promote reverse remodeling of the LV. The aim of the study is to evaluate the comparative efficacy and safety of implantation of a cardioverter-defibrillator with left bundle branch block pacing and a dual-chamber cardioverter-defibrillator in patients with HCM and complete left bundle branch block after myectomy at high risk of SCD.
- 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 to 75
You may be able to join if
- Men and women aged 18 years and older;
- Patients with post-myectomy HCM who develop LBBB with a QRS complex greater than 130 ms and a high risk of SCD (HCM Risk-SCD ≥ 6%);
- Signed informed consent to participate in the study;
You likely can't join if
- Absence of QRS complex morphology consistent with LBBB in LBBB with a positive QRS complex less than 130 ms;
- Presence of baseline complete RBBB;
- Heart transplantation or implantation of an LVAD is planned within the next 6 months;
- Patients with intermediate or low risk of SCD;
- History of AMI less than three months prior to study inclusion;
- Acute renal and hepatic failure;
See the full eligibility criteria
- Men and women aged 18 years and older;
- Patients with post-myectomy HCM who develop LBBB with a QRS complex greater than 130 ms and a high risk of SCD (HCM Risk-SCD ≥ 6%);
- Signed informed consent to participate in the study;
- Absence of QRS complex morphology consistent with LBBB in LBBB with a positive QRS complex less than 130 ms;
- Presence of baseline complete RBBB;
- Heart transplantation or implantation of an LVAD is planned within the next 6 months;
- Patients with intermediate or low risk of SCD;
- History of AMI less than three months prior to study inclusion;
- Acute renal and hepatic failure;
- Acute infectious diseases;
- Presence of mental illness;
- Presence of other illnesses for which life expectancy is less than one year;
- Patient refusal to participate in the study at any stage;
The study team makes the final eligibility decision.
Where it's taking place
- Novosibirsk, Novosibirsk Oblast, Russia
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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Novosibirsk, Novosibirsk Oblast, Russia. 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.