Dysrhythmia, CardiacVAPSNCT03387488
Video Assisted Pericardioscopic Surgery: Minimal-invasive Implantation of Epimyocardial Pacemaker Leads in Humans
A study testing StingrayTM, Medtronic® in people with Dysrhythmia, Cardiac and Heart Failure, run by RWTH Aachen University at 1 site in Germany.
Trial 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 %… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysrhythmia, Cardiac, Heart Failure, Pacemaker Electrode Infection
- What is being tested?
- StingrayTM, Medtronic®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2020to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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):
- 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
- Haemodialysis patients fulfilling the criteria for an implantation of a cardiac pacemakers due to bradycardiac dysrhythmia, OR
- Patients suffering from acute pacemaker-lead-infection, who require system-explantation and concomitant implantation of a new system
- Further inclusion criteria:
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital RWTH Aachen
Aachen, North Rhine-Westphalia, 52074
Nima Hatam, Dr. med.
About this study
Official 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.
Read more
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.
Read the 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
- Conditions
- Dysrhythmia, Cardiac, Heart Failure, Pacemaker Electrode Infection, Hemodialysis-Induced Symptom, Bradycardia
- Being tested
- StingrayTM, Medtronic®
- Medical subject headings
- Arrhythmias, Cardiac, Heart Failure, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StingrayTM, Medtronic®Device
Also called Clinical Investigational Lead Model 09090
Video- assisted pericardioscopic surgery for implanting epimyocardial pacemaker lead model 09090, Medtronic®
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | StingrayTM, Medtronic® Receives: Device: StingrayTM, Medtronic® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative mortality
The mortality will be documented as in the usual clinical routine.
Measured: 30 days
Secondary outcomes (6)
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
Measured: 7 days
Adverse events
Adverse events will be documented
Measured: 12 months
Overall survival
Overall survival will be documented as in the usual clinical routine.
Measured: 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
Measured: 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
Measured: 12 months
Risk reduction of endocarditis in dialysis/infected patients
As compared to the literature
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start1 Nov 2020 (estimated)
- Primary completion10 Feb 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysrhythmia, CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nima Hatam, Dr. med., Principal investigator, University Hospital, Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387488
- Sponsor's protocol ID
- 12-078
- Other IDs
- CIV-16-01-014366
- Acronym
- VAPS
- Status last verified
- Dec 2019
- First submitted
- 15 Dec 2017
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Assisted Pericardioscopic Surgery: Minimal-invasive Implantation of Epimyocardial Pacemaker Leads in Humans (VAPS - A Pilot Study)
- ClinicalTrials.gov ID
- NCT03387488
- Acronym / sponsor ID
- VAPS / 12-078
- Conditions
- Dysrhythmia, Cardiac, Heart Failure, Pacemaker Electrode Infection, Hemodialysis-Induced Symptom, Bradycardia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 10 Feb 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 2 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: StingrayTM, Medtronic®StingrayTM, Medtronic® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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):
- 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
- Haemodialysis patients fulfilling the criteria for an implantation of a cardiac pacemakers due to bradycardiac dysrhythmia, OR
- Patients suffering from acute pacemaker-lead-infection, who require system-explantation and concomitant implantation of a new system
- Patients aged 18 years or above
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StingrayTM, Medtronic®Also: Clinical Investigational Lead Model 09090Video- assisted pericardioscopic surgery for implanting epimyocardial pacemaker lead model 09090, Medtronic® | Device | Treatment |
Primary outcome
Operative mortality
Time frame: 30 days
The mortality will be documented as in the usual clinical routine.
6 secondary outcomes
Moderate or severe operative complications
Time frame: 7 days
Adverse events
Time frame: 12 months
Overall survival
Time frame: 12 months
Improvement of ejection mechanism
Time frame: 12 months
Improvement of ventricle coordination
Time frame: 12 months
Risk reduction of endocarditis in dialysis/infected patients
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nima Hatam, Dr. med. principal investigator
University Hospital, Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StingrayTM, Medtronic® in people with Dysrhythmia, Cardiac and Heart Failure, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nima Hatam, Dr. med. (+492418089221, nhatam@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.