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Completed

NCT Number: NCT04559945

The LEADLESS II IDE Study for the Aveir VR Leadless Pacemaker System

prospective, non-randomized, multi-center, international clinical study is designed to confirm the safety and effectiveness of the Aveir LP System in a subject population indicated for a VVI(R) pacemaker.

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Key information

Conditions

Cardiac Rhythm Disorder Arrhythmias, Cardiac Bradycardia Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foothills Medical Centre, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject must have one of the clinical indications before device implant in adherence with Medicare, ACC/AHA/HRS/ESC single chamber pacing guidelines including:
  • Chronic and/or permanent atrial fibrillation with 2° or 3° AV or bifascicular bundle branch block (BBB block), including slow ventricular rates (with or without medication) associated with atrial fibrillation; or
  • Normal sinus rhythm with 2° or 3° AV or BBB block and a low level of physical activity or short expected lifespan (but at least one year); or
  • Sinus bradycardia with infrequent pauses or unexplained syncope with EP findings; and
  • Subject is ≥18 years of age; and
  • Subject has a life expectancy of at least one year; and
  • Subject is not enrolled in another clinical investigation; and
  • Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and
  • Subject has been informed of the nature of the study, agrees to its provisions and has provided a signed written informed consent, approved by the IRB/EC; and
  • Subject is not pregnant and does not plan to get pregnant during the course of the study.

Exclusion criteria

  • Subject has known pacemaker syndrome, has retrograde VA conduction, or suffers a drop in arterial blood pressure with the onset of ventricular pacing; or
  • Subject is allergic or hypersensitive to < 1 mg of dexamethasone sodium phosphate (DSP);
  • Subject has a mechanical tricuspid valve prosthesis; or
  • Subject has a pre-existing endocardial pacing or defibrillation leads; or
  • Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device; or
  • Subject has an implanted vena cava filter; or
  • Subject has evidence of thrombosis in one of the veins used for access during the procedure; or
  • Subject had recent cardiovascular or peripheral vascular surgery within 30 days of enrollment; or
  • Subject has an implanted leadless cardiac pacemaker or
  • Subject is implanted with an electrically-active implantable medical device with stimulation capabilities (such as neurological or cardiac stimulators).

Treatment and study plan

Aveir VR Leadless Pacemaker System

Device

Patients will undergo an attempted leadless pacemaker implant

Primary outcomes

  1. Complication-Free Rate (CFR)

    Time frame: 6 weeks

    Complication is any device-or-procedure related serious adverse event, or serious adverse device effect, including those that prevented initial implantation. Complications possibly related or related to COVID-19 were excluded. Percentage of participants free from complications are reported

  2. Complication-Free Rate (CFR)

    Time frame: 12 months

    Complication is any device-or-procedure related serious adverse event, or serious adverse device effect, including those that prevented initial implantation. Complications possibly related or related to COVID-19 were excluded. The complication free rate reported describes the Kaplan-Meier estimate of the percentage of patients that had no complications at the given time point.

  3. Pacing Thresholds and R-wave Amplitudes Within the Therapeutic Range

    Time frame: 6 Weeks (Aveir VR Leadless Pacemaker arm)

    Success Rate is percentage of subjects who have acceptable pacing threshold and sensing amplitudes, which are defined as pacing threshold <=2.0V at 0.4 ms pulse width and R-wave amplitude =>5.0 mV or => value at implant.

  4. Pacing Thresholds and R-wave Amplitudes Within the Therapeutic Range

    Time frame: 12 months

    Success Rate is percentage of subjects who have acceptable pacing threshold and sensing amplitudes at 12-Month post-implant visit, which are defined as pacing threshold <=2.0V at 0.4 ms pulse width and R-wave amplitude =>5.0 mV or => value at implant.

Secondary outcomes

  1. Appropriate and Proportional Rate Response During Graded Exercise Testing

    Time frame: 3 month follow up

    Temperature-based rate response feature was evaluated to determine whether an appropriate and proportional rate response was achieved during maximal effort graded treadmill exercise testing protocol (CAEP). Subjects were asked to perform a six-minute walk test to identify optimal sensor parameters prior to conducting a CAEP test. Exercise test data provide an estimate of the slope of the normalized increase in sensor-indicated rate versus normalized workload for each subject. Normalizing a variable eliminates the unit. Since both axes are normalized, there is no unit of measure. The vertical axis is derived from the difference of the sensor indicated rate at each exercise stage and the base rate, divided by the difference of the age-predicted maximum heart rate and base rate. Values on the horizontal axis are derived from the difference in the workload at each exercise stage and resting workload, divided by the difference of the maximum achieved workload and resting workload.

  2. Survival Rate of Patients Implanted With the Nanostim Leadless Pacemaker

    Time frame: 2 years

    All-Cause Mortality through 2 years among subjects implanted with the Nanostim Leadless Pacemaker. The Nanostim Leadless Pacemaker is functionally similar to the Aveir VR Leadless Pacemaker, and was evaluated in The LEADLESS II IDE Study (Phase I) - NCT02030418. For detailed demographic and study information including adverse events, refer to NCT02030418

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

The LEADLESS II IDE Study (Phase II): A Safety and Effectiveness Trial for a Leadless Pacemaker System

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Sep 23, 2020
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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