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Trial record 47 of 721 for:    Recruiting, Not yet recruiting, Available Studies | "Arrhythmias, Cardiac"

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

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ClinicalTrials.gov Identifier: NCT03387488
Recruitment Status : Not yet recruiting
First Posted : January 2, 2018
Last Update Posted : January 2, 2018
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

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.


Condition or disease Intervention/treatment Phase
Dysrhythmia, Cardiac Heart Failure Pacemaker Electrode Infection Hemodialysis-Induced Symptom Bradycardia Device: StingrayTM, Medtronic® Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Video Assisted Pericardioscopic Surgery: Minimal-invasive Implantation of Epimyocardial Pacemaker Leads in Humans (VAPS - A Pilot Study)
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : October 1, 2019

Arm Intervention/treatment
Experimental: Treatment
StingrayTM, Medtronic®
Device: StingrayTM, Medtronic®
Video- assisted pericardioscopic surgery for implanting epimyocardial pacemaker lead Model 09090, Medtronic®
Other Name: Clinical Investigational Lead Model 09090




Primary Outcome Measures :
  1. Operative mortality [ Time Frame: 30 days ]
    The mortality will be documented as in the usual clinical routine.


Secondary Outcome Measures :
  1. Moderate or severe operative complications [ Time Frame: 7 days ]

    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

  2. Adverse events [ Time Frame: 12 months ]
    Adverse events will be documented during the operation, in visit 2 on day 1-7 postoperative (post-op), in visit 3 (1 month post-op), in visit 4 (3 months post-op), in visit 5 (6 months post-op) and in visit 6 (12 months post-op)

  3. Overall survival [ Time Frame: 12 months ]
    Overall survival will be documented as in the usual clinical routine.

  4. Improvement of ejection mechanism [ Time Frame: 12 months ]

    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


  5. Improvement of ventricle coordination [ Time Frame: 12 months ]

    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


  6. Risk reduction of endocarditis in dialysis/infected patients [ Time Frame: 12 months ]
    As compared to the literature



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03387488


Contacts
Contact: Nima Hatam, Dr. med. +492418089221 nhatam@ukaachen.de

Locations
Germany
University Hospital RWTH Aachen Not yet recruiting
Aachen, NRW, Germany, 52074
Contact: Nima Hatam, Dr. med.         
Sponsors and Collaborators
RWTH Aachen University
Investigators
Principal Investigator: Nima Hatam, Dr. med. University Hospital RWTH Aachen

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT03387488     History of Changes
Other Study ID Numbers: 12-078
CIV-16-01-014366 ( Other Identifier: EUDAMED )
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: January 2, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Heart Failure
Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes