Status:
UNKNOWN
PV Loops With CNT in Multiple Pacing Sites
Lead Sponsor:
BackBeat Medical Inc
Collaborating Sponsors:
CD Leycom
Conditions:
Bradycardia
A-V Block
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 differen...
Detailed Description
This will be a multi-center, pilot, open-label, non-randomized acute study. The Moderato System is approved for marketing in Europe (has a CE mark) for standard pacing and the treatment of high blood ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05345925
Start Date
May 2 2023
End Date
December 31 2023
Last Update
April 28 2023
Active Locations (1)
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1
University Hospital, Jagiellonian University
Krakow, Poland, 30-688