Left Bundle Branch Area Pacing (LBBAP) Monitoring Assistant: Evaluation of Portable ECG Solution
Recruiting
N/AInterventional Study
BradycardiaLeft Bundle Branch Area PacingCardiac Resynchronisation Therapy (CRT)ECG
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Other
Participants needed
55 (estimated)
Sponsor
MicroPort CRM · Industry
Who this trial is looking for
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To evaluate the capability to monitor LBB success criteria with the use of a Smart ECG system (ECG monitor, 12 leads ECG cable, ECG viewer software ) during a cardiac device implantation involving the placement of a pacing lead in interventricular septum area
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Subject with indication for LBBAP using an Electrophysiology ECG monitoring system (EP System) as part of pacemaker or CRT-P or CRT-D implant procedure (de novo implant, device revision or upgrade including LOT-CRT)
* Subject signed and dated the ICF
Exclusion Criteria:
* In…
Inclusion Criteria:
* Subject with indication for LBBAP using an Electrophysiology ECG monitoring system (EP System) as part of pacemaker or CRT-P or CRT-D implant procedure (de novo implant, device revision or upgrade including LOT-CRT)
* Subject signed and dated the ICF
Exclusion Criteria:
* Incapacitated subject or under guardianship
* inability to understand the purpose of the study
* Minor subjects
* Non menopausal women
* Patients implanted with other electrically active non cardiac devices.
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