Status:
UNKNOWN
Simultaneous or Sequential Multipoint Pacing
Lead Sponsor:
IRCCS Policlinico S. Donato
Conditions:
Cardiac Resynchronization Therapy
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to compare electrical acute changes between simultaneous and sequential LV pacing and to assess the paced QRSd over a range of inter- and intra-ventricular programmable de...
Detailed Description
The study will be a prospective, single-arm, non-randomized, non-blinded, acute study conducted at CRT device implant and prior to subject discharge. Subjects scheduled to be implanted with a Quadripo...
Eligibility Criteria
Inclusion
- Patients with approved indication for CRT by European Society of Cardiology/European Heart Rhythm Association guidelines (ESC/EHRA)
- QRS duration \> 130 ms
- Ability to provide informed consent for study participation
- At least 18 years of age
Exclusion
- Myocardial infarction within 40 days before enrolment
- NYHA Class IV
- Tachyarrhythmia caused by temporary or reversible irritation, e.g. poisoning, electrolyte imbalance, hypoxia, sepsis or acute myocardial infarction
- Such frequent VT or VF that the therapies would cause an unacceptably rapid depletion of the device batteries
- VT with few or without clinically relevant symptoms
- VT or VF treatable by surgery
- Concomitant diseases that would substantially limit a positive prognosis
- Accelerated intrinsic rhythm
- Women who are pregnant
Key Trial Info
Start Date :
November 30 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03301363
Start Date
November 30 2017
End Date
December 31 2023
Last Update
October 2 2023
Active Locations (1)
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1
IRCCS Policlinico S. Donato
San Donato Milanese, Milano, Italy, 20097