Status:
UNKNOWN
Video Assisted Pericardioscopic Surgery: Minimal-invasive Implantation of Epimyocardial Pacemaker Leads in Humans
Lead Sponsor:
RWTH Aachen University
Conditions:
Dysrhythmia, Cardiac
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Particularly in CRT (Cardiac Resynchronisation Therapy), limited accessibility of the coronary sinus along with its branches and the mismatch between the region of latest left ventricular (LV) contrac...
Detailed Description
Treatment: Video- assisted pericardioscopic surgery for implanting epimyocardial pacemaker leads Abridged Operation Protocol: 10 mm skin incision below the xiphoid process, blunt preparation toward...
Eligibility Criteria
Inclusion
- This study will include patients who are planned to undergo a pacemaker therapy within their regular medical care and who are eligible for an alternative approach for lead placement (minimal-invasive pericardioscopic surgery):
- I. Patients fulfilling current, sophisticated criteria for cardiac resynchronisation therapy (CRT) (e.g. patients with symptomatic heart failure independent of functional class, prolonged QRS-duration (especially left bundle branch block), severely depressed systolic left ventricular function), but have a history of failed CRT lead implantation or showed insufficient resynchronization after conventional CRT treatment, OR
- II. Haemodialysis patients fulfilling the criteria for an implantation of a cardiac pacemakers due to bradycardiac dysrhythmia, OR
- III. Patients suffering from acute pacemaker-lead-infection, who require system-explantation and concomitant implantation of a new system
- Further inclusion criteria:
- Patients aged 18 years or above
- Adults who are contractually capable and mentally able to understand and follow the instructions of the study personnel.
- Signed informed consent prior to study participation.
Exclusion
- Euro Score II (http://www.euroscore.org/calc.html) \> 20 %
- Patients in NYHA functional class IV
- Previous cardiac surgery / sternotomy
- Previous pericarditis
- Gender-independent myocardial wall thickness less than 5 mm
- Coexisting cardiac/vessel aneurysmata
- Patients with myocardial infarction within the last 4 weeks
- Pregnancy and breast-feeding
- Patients who are accommodated at judicial or official requests
- Patients with known anomalies of the cardiac anatomy
- Patients for whom beclometasone dipropionate is contraindicated
- Patients with bleeding disorders and coagulopathy
- Patients with a life expectancy below 12 months
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03387488
Start Date
November 1 2020
End Date
March 1 2022
Last Update
March 10 2020
Active Locations (1)
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1
University Hospital RWTH Aachen
Aachen, North Rhine-Westphalia, Germany, 52074