Ventricular TachycardiaNCT03427333
Rook Epicardial Access Device Study
A study testing The Rook® Epicardial Access Kit in people with Ventricular Tachycardia and Arrythmia, run by Talon Surgical at 1 site in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, Arrythmia
- What is being tested?
- The Rook® Epicardial Access Kit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteCzechia
- Study dates
- 18 Jan 2018to 25 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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%
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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.
- Conditions
- Ventricular Tachycardia, Arrythmia
- Being tested
- The Rook® Epicardial Access Kit
- Keywords
- VT, Pacemaker Lead Extraction, epicardial access, pericardial access
- Medical subject headings
- Tachycardia, Ventricular, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Rook® Epicardial Access KitDevice
Use of the Rook Epicardial Access Kit to gain access to the normal, non distended pericardial space.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: The Rook® Epicardial Access Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At time of intervention.
Secondary outcomes (3)
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.
Measured: Up to 4 days post procedure.
Speed of Access
Time from skin incision to confirmed guidewire access to the pericardial space.
Measured: 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.
Measured: At time of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start18 Jan 2018
- Primary completion30 Jun 2018
- Study completion25 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intervention Model: Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Talon Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427333
- Sponsor's protocol ID
- M064-035
- Status last verified
- Mar 2019
- First submitted
- 29 Jan 2018
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rook Epicardial Access Device Study
- ClinicalTrials.gov ID
- NCT03427333
- Acronym / sponsor ID
- M064-035
- Conditions
- Ventricular Tachycardia, Arrythmia
- Keywords
- VT, Pacemaker Lead Extraction, epicardial access, pericardial access
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Talon SurgicalIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 25 Feb 2019 (actual)
- First posted
- 9 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intervention Model: Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| The Rook® Epicardial Access Kit | Experimental | Device: The Rook® Epicardial Access KitThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Rook® Epicardial Access KitUse of the Rook Epicardial Access Kit to gain access to the normal, non distended pericardial space. | Device | The Rook® Epicardial Access Kit |
Primary outcome
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.
3 secondary outcomes
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.
Speed of Access
Time frame: At time of intervention
Ease of Use
Time frame: At time of intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
Related trials for Ventricular Tachycardia
Not yet recruiting
MRI-guided Ventricular Tachycardia Ablation in Patients With Structural Heart Disease
Ventricular Tachycardia (VT), Ischemic Cardiomyopathy
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Recruiting
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Ventricular Tachycardia
RecruitingPhase 1
A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Catecholaminergic Polymorphic Ventricular Tachycardia
Recruiting
SPIKE FLOW Endocardial Lead Safety and Performance Study
Acute Myocardial Infarction (AMI), Asystole
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Rook® Epicardial Access Kit in people with Ventricular Tachycardia and Arrythmia, run by Talon Surgical at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patient in Whom Successful Pericardial Access was Achieved Through Use of the Rook Epicardial Access Kit (time frame: At time of intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2019.