Status:
COMPLETED
Selected Site Pacing to Avoid Phrenic Nerve Stimulation in Cardiac Resynchronization Patients With Quadripolar Left Ventricular Leads
Lead Sponsor:
Abbott Medical Devices
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
Cardiac resynchronization (CRT) therapy is well established for treatment of patients with severe heartfailure, reduced left ventricular (LV) function and ventricular dyssynchrony. Roughly 1/3 of CRT ...
Detailed Description
Definition of an acceptable lead vector: Any LV pacing vector that complies in both tested body positions (left lateral position and sitting) with both criteria: 1. Phrenic nerve stimulation threshol...
Eligibility Criteria
Inclusion
- Indication for implantation of a CRT-D
- Age \>= 18 years
- Written informed consent
Exclusion
- Already implanted LV or coronary sinus lead
- Previous unsuccessful LV lead implant attempt
- Patient is eligible for heart transplantation
- Comorbidities that results in life expectancy of less than 12 months
- Known pregnancy
- Inability to provide written patient informed consent
- Participation to another study with active treatment arm (i.e. randomized studies etc...)
- Patient is not willing or is not able to visit the study center for the study assessments within the first 3 months after implant
- Patient is not able to understand or answer the quality of life questionaire
Key Trial Info
Start Date :
November 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
337 Patients enrolled
Trial Details
Trial ID
NCT01484613
Start Date
November 1 2011
End Date
June 1 2014
Last Update
February 4 2019
Active Locations (16)
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1
Klinikum Coburg GmbH
Coburg, Germany, 96450
2
Evangelisches Krankenhaus Kalk
Cologne, Germany, 51103
3
Krankenhaus Mörsenbroich-Rath GmbH
Düsseldorf, Germany, 40472
4
Klinikum Esslingen
Esslingen am Neckar, Germany, 73730