Video Assisted Pericardioscopic Surgery: Minimal-invasive Implantation of Epimyocardial Pacemaker Leads in Humans

NCT03387488 | Unknown

• 2 other identifiers: 12-078CIV-16-01-014366
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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) contraction and an adequate epimyocardial vein frequently lead to therapy failure and might even be responsible for the 30 % non-responders, although this aspect has not been thoroughly investigated yet. Further complications such as postoperative micro- (i.e. increased thresholds) or macro-dislodgement (i.e. loss of stimulation success) of the LV electrodes are frequent complications leading to reoperation or a change of strategy. The current transthoracic epimyocardial approach via mini-thoracotomy circumvents the aforesaid obstacles and is regarded as the first-choice alternative approach. Participation in the trial would prevent patients from this invasive, transthoracic approach and at the same time allow the same degree of freedom in lead placement. Risks and complications are in this case comparable to the open surgical approach but with a lower risk of intraoperative rib fracture, postoperative pain with consecutive pulmonary hypo-ventilation and pneumonia. Apart from the benefit of the single individual, societies benefit will include a much higher responder rate in CRT patients and less lead-associated infections. Thoracotomy with breach of the pleural cavity and single lung ventilation - a procedure that itself bears a high risk for postoperative atelectasis, pleural effusion and infection will be avoided. In patients on hemo-dialysis and patients who suffer from an infected pacemaker-system, extravascular lead placement should be preferred. Again, the current open, transthoracic epimyocardial approach via mini-thoracotomy is regarded as the first-choice alternative approach. Aim of this study is the validation of the feasibility of an alternative, minimal-invasive therapy method for implanting a cardiac pacemaker.

Conditions

Dysrhythmia, Cardiac; Heart Failure; Pacemaker Electrode Infection; Hemodialysis-Induced Symptom; Bradycardia

Outcome Measures

Primary Outcomes (1)

• Operative mortality

  The mortality will be documented as in the usual clinical routine.

  30 days

Secondary Outcomes (6)

• Moderate or severe operative complications

  7 days

• Adverse events

  12 months

• Overall survival

  12 months

• Improvement of ejection mechanism

  12 months

• Improvement of ventricle coordination

  12 months

Study Arms (1)

Treatment

EXPERIMENTAL

StingrayTM, Medtronic®

Device: StingrayTM, Medtronic®

Interventions

StingrayTM, Medtronic® DEVICE

Video- assisted pericardioscopic surgery for implanting epimyocardial pacemaker lead model 09090, Medtronic®

Also known as: Clinical Investigational Lead Model 09090

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

University Hospital RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac; Heart Failure; Bradycardia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nima Hatam, Dr. med.

  University Hospital, Aachen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nima Hatam, Dr. med.

CONTACT

+492418089221; nhatam@ukaachen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: January 2, 2018
• Study Start: November 1, 2020
• Primary Completion: February 10, 2022
• Study Completion: March 1, 2022
• Last Updated: March 10, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)