Other Clinical Trial - Evaluation of a New Cardiac Pacemaker

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Status Active, not recruiting

Clinical Trial Summary

An evaluation of a safety and performance of a new cardiac pacemaker

n/a

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Atrial Fibrillation
Atrial Fibrillation With 2 or 3° AV or Bifascicular Bundle Branch (BBB) Block
Bradycardia
Normal Sinus Rhythm With 2 or 3° AV or BBB Block
Sinus Bradycardia With Infrequent Pauses or Unexplained Syncope With EP Findings