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

NCT03387488 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-03-10

No results posted yet for this study

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.

Conditions

  • Dysrhythmia, Cardiac
  • Heart Failure
  • Pacemaker Electrode Infection
  • Hemodialysis-Induced Symptom
  • Bradycardia

Interventions

DEVICE

StingrayTM, Medtronic®

Video- assisted pericardioscopic surgery for implanting epimyocardial pacemaker lead model 09090, Medtronic®

Sponsors & Collaborators

  • RWTH Aachen University

    lead OTHER

Principal Investigators

  • Nima Hatam, Dr. med. · University Hospital, Aachen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2022-02-10
Completion
2022-03-01

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03387488 on ClinicalTrials.gov