Heart Failure Clinical Trial
— VAPSOfficial title:
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.
Status | Not yet recruiting |
Enrollment | 10 |
Est. completion date | March 1, 2022 |
Est. primary completion date | February 10, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital RWTH Aachen | Aachen | NRW |
Lead Sponsor | Collaborator |
---|---|
RWTH Aachen University |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Operative mortality | The mortality will be documented as in the usual clinical routine. | 30 days | |
Secondary | 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 | |
Secondary | Adverse events | Adverse events will be documented | 12 months | |
Secondary | Overall survival | Overall survival will be documented as in the usual clinical routine. | 12 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Risk reduction of endocarditis in dialysis/infected patients | As compared to the literature | 12 months |
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