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Completed NCT05345925

PV Loops With CNT in Multiple Pacing Sites

Conditions: Bradycardia, A-V Block

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 5
Sponsor: BackBeat Medical Inc

Location: University Hospital, Jagiellonian University Krakow

Summary

In a multicenter non-randomized acute setting, eligible subjects requiring implant or replacement of an IPG (pacemaker, ICD, CRT-P, CRT-D) will be instrumented to study the effect of CNT from different locations in the RV. CNT effects on BP will be evaluated with a PV conductance catheter in the LV, and with optional BP catheters in the aorta and/or RV. CNT will be delivered by externally by the BackBeat Moderato System IPG. Abbreviations: CNT, Cardiac Neuromodulation Therapy; IPG, Implanted Pulse Generator; ICD, Implanted Cardiac Defribillator; CRT-P or D, Cardiac Resynchronisation Therapy-Pacemaker or Defibrillator; RV, Right Ventricle; LV, Left Ventricle; BP, Blood Pressure

Eligibility Criteria

Inclusion Criteria: * Subject is ≥ 18 years of age. * Subject is indicated for an implant or a replacement with a planned upgrade of a device capable of pacing (pacemaker, ICD, CRT-P, CRT-D). * Subject is willing and able to comply with the study procedures. Exclusion Criteria: * Subject is dependent on 100% ventricular pacing. * Subject has symptoms of heart failure, NYHA Class III or greater * Subject has an ejection fraction of 25% or less * Subject's systolic blood pressure is less than 100 mmHg on the day of implant * Subject has decompensated heart failure * Subject has significant (\>2+) valvular regurgitation or any valvular stenosis. * Subject has permanent atrial fibrillation * Subject has atrial fibrillation on the day of the study. * Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy, or interventricular septal thickness ≥15 mm * Subject is on dialysis * Subject has a history of prior neurological events (stroke or TIA) within the past year or a neurological event (stroke) at any prior time that has resulted in residual neurologic deficit. * Subject has a history of autonomic dysfunction * Patient cannot receive heparin for any reason (such as a history of Heparin induced thrombocytopenia (HIT)) * Women who are pregnant or breast-feeding * Subject cannot or is unwilling to provide informed consent.

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Source: ClinicalTrials.gov (NCT05345925). StuddyBuddy aggregates publicly available trial information.