- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03427333
Rook Epicardial Access Device Study
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Prague, Czechia
- Na Homolce Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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Use of the Rook Epicardial Access Kit to gain access to the normal, non distended pericardial space.
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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
Time Frame: At time of intervention.
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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.
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At time of intervention.
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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
Time Frame: Up to 4 days post procedure.
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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.
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Up to 4 days post procedure.
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Speed of Access
Time Frame: At time of intervention
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Time from skin incision to confirmed guidewire access to the pericardial space.
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At time of intervention
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Ease of Use
Time Frame: At time of intervention.
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Evaluation of the study procedure compared to the standard of care pericardial access procedure with a Tuohy Needle by clinician survey.
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At time of intervention.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M064-035
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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