BridgeMD
New treatment option for Cardiac Pacemaker
Official title LEAP 2 Chronic EFS
ClinicalTrials.gov ID: NCT07287423
What this study is testing
- What it's testing
- Prospective, single-arm, non-randomized, unblinded, chronic feasibility study designed to evaluate the safety and performance of the AVEIR™ Conduction System Pacing (CSP) Leadless Pacemaker system.
- 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 must have at least one standard pacemaker indication
- Subject must be at least 18 years of age
- Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams
- Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent...
You likely can't join if
- Subject has a mechanical tricuspid valve, percutaneous tricuspid valve repair or replacement, or an implanted vena cava filter
- Subject has evidence of tricuspid stenosis, tricuspid atresia, or presence of any condition that precludes appropriate vascular access for the study...
- Subject has previous myocardial infarction
- Subject is expected to be pacemaker dependent
- Subject has a previous or existing lead or device in the right heart or interventricular septum (includes lead fragments, temporary pacing leads, and...
- Subject has an active implantable electronic device that cannot be turned off during the study procedure
See the full eligibility criteria
- Subject must have at least one standard pacemaker indication
- Subject must be at least 18 years of age
- Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams
- Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, as approved by the local EC
- Subject has a mechanical tricuspid valve, percutaneous tricuspid valve repair or replacement, or an implanted vena cava filter
- Subject has evidence of tricuspid stenosis, tricuspid atresia, or presence of any condition that precludes appropriate vascular access for the study procedure
- Subject has previous myocardial infarction
- Subject is expected to be pacemaker dependent
- Subject has a previous or existing lead or device in the right heart or interventricular septum (includes lead fragments, temporary pacing leads, and closure devices)
- Subject has an active implantable electronic device that cannot be turned off during the study procedure
- Subject has recent cardiovascular or peripheral vascular surgery within 30 days of enrollment
- Subject has known allergy or hypersensitivity to \< 1 mg of dexamethasone sodium phosphate or any blood or tissue contacting material used in the study procedure
- Subject is unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
- Subject has known chronic renal insufficiency including patients on dialysis
- Subject has an active systemic infection
- Subject has known history or repair of an atrial septal defect, patent foramen ovale, or ventricular septal defect
- Subject is currently participating in another clinical investigation that might impact the outcomes of the clinical investigation
- Pregnant or nursing people and those who plan pregnancy during the clinical investigation follow-up period
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical...
- Subject is unable to read or write
The study team makes the final eligibility decision.
Where it's taking place
- Prague, Czechia
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Prague, Czechia. 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.