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
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|
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)|
|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|
Device: StingrayTM, Medtronic®
Video- assisted pericardioscopic surgery for implanting epimyocardial pacemaker lead Model 09090, Medtronic®
Other Name: Clinical Investigational Lead Model 09090
- Operative mortality [ Time Frame: 30 days ]The mortality will be documented as in the usual clinical routine.
- 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:
- Pleural effusion
- Postoperative pain obtained by visual analog pain scale
- 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)
- Overall survival [ Time Frame: 12 months ]Overall survival will be documented as in the usual clinical routine.
- 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
- 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
- Risk reduction of endocarditis in dialysis/infected patients [ Time Frame: 12 months ]As compared to the literature
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
|Contact: Nima Hatam, Dr. firstname.lastname@example.org|
|University Hospital RWTH Aachen||Not yet recruiting|
|Aachen, NRW, Germany, 52074|
|Contact: Nima Hatam, Dr. med.|
|Principal Investigator:||Nima Hatam, Dr. med.||University Hospital RWTH Aachen|