Leadless Conduction System Pacemaker for Chronic Bradycardia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm feasibility study evaluating the AVEIR Conduction System Pacing Leadless Pacemaker in patients with standard pacing indications. Participants will be followed from the implant through multiple post-procedure visits over at least a year, with data collection at baseline, during implantation, and at 1, 2, 3, 6, and 12 months and then every six months. The aim is to assess chronic safety and performance of the leadless system in real-world use. The study does not include randomization or blinding and focuses on feasibility in a specific patient population. Data will inform long-term outcomes and potential broader use of this technology.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subject must have at least one standard pacemaker indication
2. Subject must be at least 18 years of age
3. Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams
4. 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

Exclusion Criteria:

1. Subject has a mechanical tricuspid valve, percutaneous tricuspid valve repair or replacement, or an implanted vena cava filter
2. Subject has evidence of tricuspid stenosis, tricuspid atresia, or presence of any condition that precludes appropriate vascular access for the study procedure
3. Subject has previous myocardial infarction
4. Subject is expected to be pacemaker dependent
5. 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)
6. Subject has an active implantable electronic device that cannot be turned off during the study procedure
7. Subject has recent cardiovascular or peripheral vascular surgery within 30 days of enrollment
8. 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
9. Subject is unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
10. Subject has known chronic renal insufficiency including patients on dialysis
11. Subject has an active systemic infection
12. Subject has known history or repair of an atrial septal defect, patent foramen ovale, or ventricular septal defect
13. Subject is currently participating in another clinical investigation that might impact the outcomes of the clinical investigation
14. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
15. 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 investigation or to comply with the follow-up requirements of the clinical investigation
16. Subject is unable to read or write

Where it's running

• Nemocnice Na Homolce
  Prague, Czechia Recruiting

Study contacts

• Principal investigator: Vivek Y Reddy, MD — The Mount Sinai Hospital
• Study coordinator: Kwangdeok Lee, PhD
• Email: kwangdeok.lee@abbott.com
• Phone: 972-526-9673

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• BIOTRONIK CSP Lead Registry for Left Bundle Branch Area Pacing

  This registry tests BIOTRONIK’s CSP-based pacing lead in patients needing a pacemaker or CRT, to see how it performs in real-life use.

  Recruiting at 12 sites Biotronik SE & Co. KG · Adelaide and 45 other locations · NCT07393009

• LivIQ leadless pacemaker system for ventricular pacing

  This trial will test the LivIQ leadless pacemaker in adults who need ventricular pacing (VVI or VDD) to see if it is safe and maintains appropriate heart rhythm and AV timing.

  Recruiting at 41 sites Biotronik, Inc. · Burlingame, California and 42 other locations · NCT07118358

• Evaluating the Aveir Atrial Leadless Pacemaker for Medicare Patients

  This study is testing how well the Aveir Atrial Leadless Pacemaker works and what complications it might cause for Medicare patients compared to a regular pacemaker.

  Recruiting Abbott Medical Devices · Sylmar, California · NCT06100770

• Evaluating the long-term safety of the Aveir DR leadless pacemaker

  This study is testing the long-term safety of the Aveir DR leadless pacemaker in real-world patients to make sure it’s safe for use.

  Recruiting Abbott Medical Devices · Sylmar, California · NCT05935007

• SPIKE FLOW endocardial pacing lead safety and performance study

  This study tests whether the SPIKE FLOW temporary endocardial pacing lead is safe and effective in adults needing temporary pacing during heart-related conditions.

  Recruiting at 2 sites FIAB SpA · Acquaviva delle Fonti, Bari and 2 other locations · NCT07820072

• Factors Linked to Slow Heart Rate After Pulsed Field Ablation for Atrial Fibrillation

  This study looks for factors that might cause bradycardia during the hospital stay after AF ablation using pulsed field technology.

  Recruiting Wroclaw Medical University · Wroclaw, Lower Silesian Voivodeship · NCT07809347

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.