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

March 9, 2020 updated by: RWTH Aachen University

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
    • NRW
      • Aachen, NRW, Germany, 52074
        • University Hospital RWTH Aachen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Operative mortality
Time Frame: 30 days
The mortality will be documented as in the usual clinical routine.
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
7 days
Adverse events
Time Frame: 12 months
Adverse events will be documented
12 months
Overall survival
Time Frame: 12 months
Overall survival will be documented as in the usual clinical routine.
12 months
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
12 months
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
12 months
Risk reduction of endocarditis in dialysis/infected patients
Time Frame: 12 months
As compared to the literature
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RWTH Aachen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nima Hatam, Dr. med., University Hospital RWTH Aachen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 10, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 2, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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