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