Rook Epicardial Access Device Study

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.

Study Overview

• Status: Completed
• Conditions: Ventricular Tachycardia; Arrythmia
• Intervention / Treatment: Device: The Rook® Epicardial Access Kit

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
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia
    • Na Homolce Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patient in Whom Successful Pericardial Access was Achieved Through Use of the Rook Epicardial Access Kit	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.	At time of intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Device or Procedure Related Adverse Events as Adjudicated by the Clinical Event Committee	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.	Up to 4 days post procedure.
Speed of Access	Time from skin incision to confirmed guidewire access to the pericardial space.	At time of intervention
Ease of Use	Evaluation of the study procedure compared to the standard of care pericardial access procedure with a Tuohy Needle by clinician survey.	At time of intervention.

Collaborators and Investigators

• Sponsor: Talon Surgical

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 18, 2018
• Primary Completion (ACTUAL): June 30, 2018
• Study Completion (ACTUAL): February 25, 2019

Study Registration Dates

• First Submitted: January 29, 2018
• First Submitted That Met QC Criteria: February 2, 2018
• First Posted (ACTUAL): February 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 29, 2019
• Last Update Submitted That Met QC Criteria: March 27, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: VT; pericardial access; Pacemaker Lead Extraction; epicardial access
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: M064-035

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes