At a glance
ClinicalIndex Comparison RecordN/ACompleted· 64 enrolled
Drug / intervention
CRT-P indicated patientsdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Optimizing Pacing Therapy by Using Multi-Programmable Pulse Generators for Cardiac Resynchronization Pacing (CRT-P)
In Brief
An observational study evaluating CRT-P indicated patients for Post Market Surveillance Study Following Clinical Routine. Completed, enrolled 64 participants across 8 sites in 2 countries.
Detailed Summary
The objective of this Post Market Clinical Follow-up (PMCF) is to collect data on the performance of the Ingenio 2 CRT-P devices and to document that device-related events, device malfunctions or device deficiencies (DDs) do not increase safety risks in Ingenio 2 CRT-P devices (CRT-Ps), both in general and specific to the new features and hardware of the devices.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFinland, Germany
CollaboratorsICON plc
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartMay 2015
First PostedJul 2015
Primary CompletionMar 2017
TodayJul 2026
First PostedJul 2, 2015
Enrollment StartMay 1, 2015
Primary CompletionMar 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 11 years ago
Interventions
CRT-P indicated patientsdevice
Patients who are indicated for a CRT-P device are planned to be implanted with a CRT-P device