BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System

Part of paid clinical trials in Burlingame, California.

Sponsor
Biotronik, Inc.
Study ID
NCT07118358
Status
Recruiting
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Conditions

  • AV Block
  • Bradycardia
  • Cardiac Rhythm Disorder
  • Leadless Pacemaker

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LivIQ Leadless Pacemaker System — DEVICE
    Patients will receive a single-chamber leadless pacemaker system, with the device implanted directly into the right ventricle.

Study Details

The objective of this Investigational Device Exemption trial is to confirm the safety and performance of the LivIQ leadless pacemaker system, in patients with a Class I or II indication for ventricular pacing (VVI/VDD) according to applicable guidelines. An integrated atrioventricular synchrony sub-study (AVS) is specifically designed to evaluate the AVS performance of the LivIQ system.

Key Dates

First listed
Aug 12, 2025
Start date
Mar 16, 2026
Status verified
Jun 2026
Primary completion
Mar 31, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
325 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Non randomized arm
    Single Arm

Primary Outcome Measure

Freedom from Serious Adverse Device Effects [ Time Frame: 3 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Sutter HealthBurlingameCalifornia94010-
MemorialCare Saddleback MedicalLaguna HillsCalifornia92653-
Trinity Health Ann Arbor HospitalYpsilantiMichigan48197-
NY Presbyterian Weill Cornell MedicineNew YorkNew York10021-
Wake Forest University HealthWinston-SalemNorth Carolina27157-
Cardiology Consultants of PhiladelphiaPaoliPennsylvania19301-
UVA Health University Medical CenterCharlottesvilleVirginia22903-

Find similar trials in Burlingame, CA

By research site
Sutter Health· Burlingame, CAMemorialCare Saddleback Medical· Laguna Hills, CATrinity Health Ann Arbor Hospital· Ypsilanti, MINY Presbyterian Weill Cornell Medicine· New York, NYWake Forest University Health· Winston-Salem, NCCardiology Consultants of Philadelphia· Paoli, PA

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