Atrial FlutterNCT01139814
Clinical Study to Evaluate the Catheter Robotics Amigo for Performing Right-Sided Electrophysiology Mapping Studies
A study testing Amigo catheter robot in people with Atrial Flutter and Ventricular Tachycardia, run by Catheter Robotics, Inc. at 12 sites in 2 countries.
Trial summary
The purpose of this clinical study is to collect safety and performance data to support a demonstration of substantial equivalence of the Catheter Robotics Remote Catheter System to predicate devices when used to perform EP mapping of the right heart (atrium and ventricle). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Flutter, Ventricular Tachycardia
- What is being tested?
- Amigo catheter robot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Jun 2010to Oct 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- > 18years of age.
- Indicated for a right-sided electrophysiology ablation study (e.g., atrial flutter, AVNRT, right-sided accessory pathway, or ventricular tachycardia).
- Willingness, ability, and commitment to participate in the procedure visit and a follow-up evaluation including a clinic visit at 7 (-0, +7) days after the study procedure.
- Completion of Informed Consent.
Who cannot join
- Any contraindication to cardiac catheterization, including pregnancy.
- Enrollment in any other ongoing cardiac device trial.
- Right-sided cardiac prosthetics including implanted active energy devices with permanent leads in or through the right atrium and/or ventricle.
- Corrected or uncorrected atrial septal defect (ASD).
- Poor general health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate (i.e., other disease processes, mental capacity, etc.).
- Medical condition that will require anticoagulation during study or ablation procedure.
Show all 9Show fewer
- Presence of atrial fibrillation or atrial flutter at time of study procedure.
- Other condition observed prior to the procedure where, in the view of the physician, participation in the study could further present a risk to the subject.
- -
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States11 sites
Lone Star Heart Center
Amarillo, Texas, 79106
Johns Hopkins University
Baltimore, Maryland, 21287
Northwestern Medical Center
Chicago, Illinois, 60611
Genesis Health,
Davenport, Iowa, 52803
Lancaster Heart & Stroke Foundation
Lancaster, Pennsylvania, 17602
Gagnon Cardiovascular Institute/Morristown Memorial Hospital
Morristown, New Jersey, 07962
Ochsner Medical Center
New Orleans, Louisiana, 70121
Lenox Hill Hospital
New York, New York, 10075
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92658
Sequoia Hospital
Redwood City, California, 94062
Valley Health
Winchester, Virginia, 22601
About this study
Official title: Clinical Study to Evaluate the Effectiveness and Safety of the Catheter Robotics Amigo Remote Catheter System for Performing Right-Sided Electrophysiology Mapping Studies
The purpose of this clinical study is to collect safety and performance data to support a demonstration of substantial equivalence of the Catheter Robotics Remote Catheter System to predicate devices when used to perform EP mapping of the right heart (atrium and ventricle).
- Conditions
- Atrial Flutter, Ventricular Tachycardia
- Being tested
- Amigo catheter robot
- Keywords
- atrial flutter, AVNRT, right sided accessory pathway, ventricular tachycardia, Patients who have one or more standard indications for a right-sided diagnostic electrophysiology procedure.
- Medical subject headings
- Atrial Flutter, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amigo catheter robotDevice
The Amigo Catheter System is intended to facilitate manipulation, positioning and control of a Diagnostic Catheter.
| Study group | Role | What they receive |
|---|---|---|
| Catheter Robot | Experimental | device Receives: Device: Amigo catheter robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Navigation Performance
Effectiveness Navigation Performance -- The ability to navigate the mapping catheter under Amigo control to at least 80% of 8 pre-specified anatomical locations over all subjects.
Measured: During Procedure
Evaluation of Major Complications
Safety Evaluation of Major Complications definitely or probably related to Amigo-Controlled Mapping through Visit 3 follow-up.
Measured: Seven Days (visit 3), except for any subject with an ongoing SAE that is related to the study will be scheduled for additional evaluations at 14 day intervals.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FlutterStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catheter Robotics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01139814
- Sponsor's protocol ID
- 2008-001-01
- Status last verified
- Apr 2013
- First submitted
- 7 Jun 2010
- Last updated
- 11 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Khan EM, Frumkin W, Ng GA, Neelagaru S, Abi-Samra FM, Lee J, Giudici M, Gohn D, Winkle RA, Sussman J, Knight BP, Berman A, Calkins H. First experience with a novel robotic remote catheter system: Amigo mapping trial. J Interv Card Electrophysiol. 2013 Aug;37(2):121-9. doi: 10.1007/s10840-013-9791-9. Epub 2013 May 1.
PubMed 23636870
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Effectiveness and Safety of the Catheter Robotics Amigo Remote Catheter System for Performing Right-Sided Electrophysiology Mapping Studies
- ClinicalTrials.gov ID
- NCT01139814
- Acronym / sponsor ID
- 2008-001-01
- Conditions
- Atrial Flutter, Ventricular Tachycardia
- Keywords
- atrial flutter, AVNRT, right sided accessory pathway, ventricular tachycardia, Patients who have one or more standard indications for a right-sided diagnostic electrophysiology procedure.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Catheter Robotics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Study start
- Jun 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 9 Jun 2010 (estimated)
- Results
- Posted 10 Apr 2013
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 clinical study is to collect safety and performance data to support a demonstration of substantial equivalence of the Catheter Robotics Remote Catheter System to predicate devices when used to perform EP mapping of the right heart (atrium and ventricle).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Catheter Robot | Experimental | Device: Amigo catheter robotdevice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 18years of age.
- Indicated for a right-sided electrophysiology ablation study (e.g., atrial flutter, AVNRT, right-sided accessory pathway, or ventricular tachycardia).
- Willingness, ability, and commitment to participate in the procedure visit and a follow-up evaluation including a clinic visit at 7 (-0, +7) days after the study procedure.
- Completion of Informed Consent.
Key exclusion criteria (9 listed)
- Any contraindication to cardiac catheterization, including pregnancy.
- Enrollment in any other ongoing cardiac device trial.
- Right-sided cardiac prosthetics including implanted active energy devices with permanent leads in or through the right atrium and/or ventricle.
- Corrected or uncorrected atrial septal defect (ASD).
- Poor general health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate (i.e., other disease processes, mental capacity, etc.).
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 |
|---|---|---|
| Amigo catheter robotThe Amigo Catheter System is intended to facilitate manipulation, positioning and control of a Diagnostic Catheter. | Device | Catheter Robot |
Primary outcome
Navigation Performance
Time frame: During Procedure
Effectiveness Navigation Performance -- The ability to navigate the mapping catheter under Amigo control to at least 80% of 8 pre-specified anatomical locations over all subjects.
Evaluation of Major Complications
Time frame: Seven Days (visit 3), except for any subject with an ongoing SAE that is related to the study will be scheduled for additional evaluations at 14 day intervals.
Safety Evaluation of Major Complications definitely or probably related to Amigo-Controlled Mapping through Visit 3 follow-up.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23636870Khan EM, Frumkin W, Ng GA, Neelagaru S, Abi-Samra FM, Lee J, Giudici M, Gohn D, Winkle RA, Sussman J, Knight BP, Berman A, Calkins H. First experience with a novel robotic remote catheter system: Amigo mapping trial. J Interv Card Electrophysiol. 2013 Aug;37(2):121-9. doi: 10.1007/s10840-013-9791-9. Epub 2013 May 1.
Related trials for Atrial Flutter
Recruiting
Anatomical Navigation for Guided Electrophysiology in AFL and AFib
Atrial Fibrillation, Atrial Flutter
Recruiting
Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures
Atrial Fibrillation, Atrial Flutter
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Active, not recruiting
Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System
Persistent Atrial Fibrillation
Recruiting
Pericardiotomy in Cardiac Surgery
Atrial Fibrillation, Atrial Flutter
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.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amigo catheter robot in people with Atrial Flutter and Ventricular Tachycardia, run by Catheter Robotics, Inc. at 12 sites in 2 countries.
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 4 inclusion and 9 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 11 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 10 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Navigation Performance (time frame: During Procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01139814, which also lists 1 linked publication.
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 11 Apr 2013.