Aveir Dual-Chamber Leadless i2i IDE Study

Brief description of study

The Aveir DR i2i study will be the first in-human evaluation of the Aveir DR LP system. The purpose of this clinical investigation is to evaluate the clinical safety and effectiveness of the Aveir DR LP system in a patient population indicated for a DDD(R) pacemaker. The results of this clinical investigation will support regulatory pre-market submissions for the Aveir DR LP system for DDD(R) pacing indications and the Aveir atrial LP for AAI(R) pacing indications in various geographies.

Clinical Study Identifier: s21-01237
ClinicalTrials.gov Identifier: NCT05252702
Principal Investigator: Larry A Chinitz.
Other Investigator: Lior Jankelson.

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