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Rook Epicardial Access Device Study

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ClinicalTrials.gov Identifier: NCT03427333
Recruitment Status : Recruiting
First Posted : February 9, 2018
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
Talon Surgical

Brief Summary:
The purpose of this study is to confirm the efficacy and safety of the Talon Surgical Rook® Epicardial Access Kit as a pericardial access device. The Rook® Epicardial Access Kit will be used to gain access the epicardial surface of the heart via a subxiphoid approach in adult patients with a normal, non-distended pericardial space.

Condition or disease Intervention/treatment Phase
Ventricular Tachycardia Arrythmia Device: The Rook® Epicardial Access Kit Not Applicable

Detailed Description:

This is a first-in-human, prospective, non-randomized, single arm study to confirm the efficacy and safety of the Talon Surgical Rook® Epicardial Access Kit to achieve guidewire access to the pericardial space. Patients who are clinically indicated to undergo a procedure that requires percutaneous access to the normal, non-distended, pericardial space will be considered for enrollment into this clinical trial. This may include, but is not limited to, patients who require pericardial access for epicardial ablation procedure or for pigtail catheter placement during pacemaker lead extraction. The study population will consist of both male and female patients of at least 18 years of age. In addition, eligible patients will have a life expectancy of at least 6 months based on a physician's assessment of the patient's medical condition. Patients who meet all inclusion and non-exclusion criteria, who are willing to comply with study follow-up requirements, and for whom documented informed consent is obtained, will be eligible for enrollment in the study. Enrollment occurs when the device enters the body.

Patients who undergo attempted use of a study device (patient leaves procedure room with device having entered the body at some point during the procedure), regardless of whether or not the device was successfully used for pericardial access, will be followed through discharge or up to 4 days post procedure, whichever comes first.

The study will include a minimum of 10 patients and up to 30 patients with the study devices used for pericardial access. Multiple study site may be utilized. The duration of participation for each enrolled patient who utilizes a study device for pericardial access will be through hospital discharge, or up to 4 days post procedure, whichever comes first.

A study physician will utilize the Rook® Epicardial Access Kit to gain access to the pericardial space. The physician will follow the patient through hospital discharge, or up to 4 days post procedure, whichever comes first, for adverse events, and other device or procedure related observations. The study coordinator or designated study personnel at the Principle Investigator's office will be responsible for collecting data from the procedure and hospital stay which will be necessary for completion of case report form for the index procedure and subsequent follow up.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Rook Epicardial Access Device Study
Actual Study Start Date : January 18, 2018
Estimated Primary Completion Date : May 1, 2018
Estimated Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: The Rook® Epicardial Access Kit
The Rook® Epicardial Access Kit will be used to gain access the epicardial surface of the heart via a subxiphoid approach in adult patients with a normal, non-distended pericardial space.
Device: The Rook® Epicardial Access Kit
Use of the Rook Epicardial Access Kit to gain access to the normal, non distended pericardial space.




Primary Outcome Measures :
  1. Percentage of Patient in Whom Successful Pericardial Access was Achieved Through Use of the Rook Epicardial Access Kit [ Time Frame: At time of intervention. ]
    Standard x-ray (fluoroscopy) will be used to confirm that the Talon Surgical Rook® Epicardial Access Kit facilitated successful placement of a guidewireinto the pericardial space. Successful placement of the guidewire into the pericardial space will be noted for each patient. The percentage of patients in whom pericardial access was successful will be reported.


Secondary Outcome Measures :
  1. Number of Participants with Device or Procedure Related Adverse Events as Adjudicated by the Clinical Event Committee [ Time Frame: Up to 4 days post procedure. ]
    Occurrence of CEC-adjudicated device or procedure related adverse events through hospital discharge or up to 4 days post procedure, whichever comes first, will be documented for each patient. The total number of patients with adverse events and the number of each adverse events will be reported. This outcome will also be reported as a percentage.

  2. Speed of Access [ Time Frame: At time of intervention ]
    Time from skin incision to confirmed guidewire access to the pericardial space.

  3. Ease of Use [ Time Frame: At time of intervention. ]
    Evaluation of the study procedure compared to the standard of care pericardial access procedure with a Tuohy Needle by clinician survey.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is clinically indicated to undergo a procedure that requires percutaneous access to the normal, non-distended, pericardial space.
  • Patient is willing and able to provide written informed consent.

Exclusion Criteria:

  • Subject is younger than 18 years of age
  • Previous cardiac surgery
  • Myocardial infarction within 4 weeks prior to procedure
  • Class IV NYHA (New York Heart Association) heart failure symptoms
  • Subject with an active systemic infection
  • Known carotid artery stenosis greater than 80%
  • Presence of thrombus in the left atrium
  • Congenital absence of a pericardium
  • Coagulopathy
  • Hemodynamic Instability
  • Acute conditions (i.e. electrolyte abnormality, acute ischemia, drug toxicity)
  • Severe hepatic dysfunction or enlargement
  • Subject has Body Mass Index > 40
  • Life expectancy less than 6 months
  • Subject is pregnant
  • Subject is currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study
  • Subject has known or suspected allergy to contrast media

Information from the National Library of Medicine

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): NCT03427333


Contacts
Contact: Nathaniel Young 801-597-5863 nate.young@talonsurgical.com
Contact: Jay Muse 3857430644 jay.muse@talonsurgical.com

Locations
Czechia
Na Homolce Hospital Recruiting
Prague, Czechia
Contact: Katerina Mzourkova    +420 606 532 420    katerina.mzourkova@homolka.cz   
Principal Investigator: Petr Neuzil, MD PhD         
Principal Investigator: Vivek Reddy, MD         
Sponsors and Collaborators
Talon Surgical

Responsible Party: Talon Surgical
ClinicalTrials.gov Identifier: NCT03427333     History of Changes
Other Study ID Numbers: M064-035
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Talon Surgical:
VT
Pacemaker Lead Extraction
epicardial access
pericardial access

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes