Clinical trial for Heart Failure
Official title Advancing Clinical Heart Failure Outcomes Leveraging Defibrillation Lead Implant System for Left Bundle Branch Area Pacing
ClinicalTrials.gov ID: NCT07526896
What this study is testing
- What it's testing
- The study compares two pacing methods to see if adding left‑ventricle pacing improves heart function, measured by echo scans and other tests.
- Who it's for
- Adults with heart failure who need a cardiac resynchronization device and have left bundle branch block.
- What's involved
- Participants will receive two different pacing setups, each for six months, with regular heart‑function tests and questionnaires. Some patients who cannot get the new setup will be observed as well.
- Time commitment
- The study lasts about 12 months, with visits and tests every few weeks during each six‑month period.
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
- Subject meets current ACC/AHA/HRS guidelines for implantation of a CRT-D device.
- Subject has documented LVEF ≤ 35% within 60 days of enrollment.
- Subject meets the criteria for presence of Strauss-defined LBBB.
- Subject meets NYHA classification II or III.
- Subject is willing and able to provide written consent.
You likely can't join if
- Subject has documented myocardial infarction before enrollment.
- Subject has non-LBBB conduction patterns such as Right Bundle Branch Block (RBBB) or non-specific IVCD.
- Subject has 2nd or 3rd degree AV block.
- Subject has persistent or permanent atrial fibrillation (AF) or atrial flutter (AFL).
- Subject has intrinsic (non-paced) QRS duration ≤ 120ms.
- Subject with previous or existing pacemaker (including transvenous and transcatheter pacing system), Implantable Cardioverter Defibrillator (ICD...
See the full eligibility criteria
- Subject meets current ACC/AHA/HRS guidelines for implantation of a CRT-D device.
- Subject has documented LVEF ≤ 35% within 60 days of enrollment.
- Subject meets the criteria for presence of Strauss-defined LBBB.
- Subject meets NYHA classification II or III.
- Subject is willing and able to provide written consent.
- Subject is at least 18 years of age at the time of consent.
- Subject is geographically stable and willing and able to complete study procedures, including follow-up visits.
- The subject's medical records must be accessible by the enrolling site over the follow-up period.
- Subject has documented myocardial infarction before enrollment.
- Subject has non-LBBB conduction patterns such as Right Bundle Branch Block (RBBB) or non-specific IVCD.
- Subject has 2nd or 3rd degree AV block.
- Subject has persistent or permanent atrial fibrillation (AF) or atrial flutter (AFL).
- Subject has intrinsic (non-paced) QRS duration ≤ 120ms.
- Subject with previous or existing pacemaker (including transvenous and transcatheter pacing system), Implantable Cardioverter Defibrillator (ICD, transvenous) or CRT-D (transvenous) device or leads.
- Subject has contraindications for screw-in transvenous lead placement (e.g., mechanical right heart valve).
- Subject underwent valve surgery within 90 days prior to enrollment.
- Subject is unable or unwilling to undergo baseline CMR imaging, if previously collected CMR images are unavailable or do not meet minimum acceptable criteria.
- Subject is post-heart transplantation or is actively listed on the transplantation list.
- Subject is implanted with a left ventricular assist device (LVAD).
- Subject has severe renal disease.
- Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure.
- Subject has complex and uncorrected congenital heart disease.
- Subject has life expectancy of less than 12 months.
- Subject is pregnant or breastfeeding.
- Subject is enrolled or planning to enroll in a concurrent clinical study that may confound the results of this study, without documented pre-approval from a Medtronic study manager.
The study team makes the final eligibility decision.
Where it is enrolling
- Minneapolis, Minnesota, United States
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 Minneapolis, Minnesota, United States. 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.