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

Video Assisted Pericardioscopic Surgery: Minimal-invasive Implantation of Epimyocardial Pacemaker Leads in Humans (VAPS - A Pilot Study)

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Bradycardia; Hemodialysis-Induced Symptom; Pacemaker Electrode Infection; Dysrhythmia, Cardiac
• Intervention / Treatment: Device: StingrayTM, Medtronic®

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 towards the pericardial sac, insertion of the endoscope-carrying trocar, opening of the pericardium with endoscopic forceps, standardised inspection of the pericardial cavity, insertion of the bipolar Stingray® electrode via the endoscope working channel into pericardial space, implantation of the electrode into designated epimyocardial site under endoscopic vision, pacing measurements sensing, impedance, pacing threshold, interventricular delay (in CRT), panoramic fluoroscopy for future controls, retraction of the endoscope/trocar, subcutaneous tunnelling and connection of the respective electrode to:

• existing, infraclavicular CRT device, suture in layers, wound dressing
• a single- or dual-chamber pacemaker device implanted epigastrically, suture in layers, wound dressing

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nima Hatam, Dr. med.; Phone Number: +492418089221; Email: nhatam@ukaachen.de

Study Locations

• Germany
  • NRW
    • Aachen, NRW, Germany, 52074
      • University Hospital RWTH Aachen
      • Contact: Nima Hatam, Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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:

1. Patients aged 18 years or above
2. Adults who are contractually capable and mentally able to understand and follow the instructions of the study personnel.
3. Signed informed consent prior to study participation.

Exclusion Criteria:

1. Euro Score II (http://www.euroscore.org/calc.html) > 20 %
2. Patients in NYHA functional class IV
3. Previous cardiac surgery / sternotomy
4. Previous pericarditis
5. Gender-independent myocardial wall thickness less than 5 mm
6. Coexisting cardiac/vessel aneurysmata
7. Patients with myocardial infarction within the last 4 weeks
8. Pregnancy and breast-feeding
9. Patients who are accommodated at judicial or official requests
10. Patients with known anomalies of the cardiac anatomy
11. Patients for whom beclometasone dipropionate is contraindicated
12. Patients with bleeding disorders and coagulopathy
13. Patients with a life expectancy below 12 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; StingrayTM, Medtronic®	Device: StingrayTM, Medtronic®; Video- assisted pericardioscopic surgery for implanting epimyocardial pacemaker lead model 09090, Medtronic®; Other Names: Clinical Investigational Lead Model 09090

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative mortality	The mortality will be documented as in the usual clinical routine.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Moderate or severe operative complications	Operative complications (e.g. cardiac tamponade, severe bleeding, infection, lead dislodgement, pacing thresholds etc.) will be documented. Reduction of procedure-related postoperative complications, particular pulmonic complications in comparison to thoracotomy: Duration of mechanical ventilation; Occurrence of pulmonary ventilation disorders:; Atelectasis; Pleural effusion; Pneumothorax; Postoperative pain obtained by visual analog pain scale	7 days
Adverse events	Adverse events will be documented	12 months
Overall survival	Overall survival will be documented as in the usual clinical routine.	12 months
Improvement of ejection mechanism	The acute and long-term effects of left-ventricular epimyocardial lead implantation/stimulation obtained by transthoracic echocardiography 1: Ejection fraction in percent, pre- and postoperative	12 months
Improvement of ventricle coordination	The acute and long-term effects of left-ventricular epimyocardial lead implantation/stimulation obtained by transthoracic echocardiography 2: Inter- and intraventricular delay in miliseconds, pre- and postoperative	12 months
Risk reduction of endocarditis in dialysis/infected patients	As compared to the literature	12 months

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Investigators: Principal Investigator: Nima Hatam, Dr. med., University Hospital RWTH Aachen

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2020
• Primary Completion (Anticipated): February 10, 2022
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: December 15, 2017
• First Submitted That Met QC Criteria: December 21, 2017
• First Posted (Actual): January 2, 2018

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Bradycardia; Arrhythmias, Cardiac
• Other Study ID Numbers: 12-078; CIV-16-01-014366 (Other Identifier: EUDAMED)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No