Rook Epicardial Access Device Study

NCT03427333 | Completed DMC FDA Device

• 1 other identifier: M064-035
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventricular Tachycardia; Arrythmia

Keywords

VT; Pacemaker Lead Extraction; epicardial access; pericardial access

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Participants with Device or Procedure Related Adverse Events as Adjudicated by the Clinical Event Committee

  Up to 4 days post procedure.

• Speed of Access

  At time of intervention

• Ease of Use

  At time of intervention.

Study Arms (1)

The Rook® Epicardial Access Kit

EXPERIMENTAL

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

Interventions

The Rook® Epicardial Access Kit DEVICE

Use of the Rook Epicardial Access Kit to gain access to the normal, non distended pericardial space.

The Rook® Epicardial Access Kit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Talon Surgical: lead

Study Sites (1)

Na Homolce Hospital

Prague, Czechia

Location

MeSH Terms

Conditions

Tachycardia, Ventricular; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Tachycardia; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Intervention Model: Single Group Assignment

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 9, 2018
• Study Start: January 18, 2018
• Primary Completion: June 30, 2018
• Study Completion: February 25, 2019
• Last Updated: March 29, 2019

Record last verified: 2019-03

Locations

CZ (1)