Atrial FibrillationNCT00950092
nContactSurgical Numeris-AF Tethered Coagulation System for Treatment of Persistent & LSP AF
A study testing Numeris-AF Tethered Coagulation System with VisiTrax in people with Atrial Fibrillation, run by nContact Surgical Inc. at 2 sites in United States.
Trial summary
This is a multi center, non-randomized, prospective, open label, clinical trial evaluating the safety and efficacy of the nContact Surgical Numeris-AF Tethered Coagulation System when used to treat patients with persistent and longstanding persistent AF during concomitant cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Numeris-AF Tethered Coagulation System with VisiTrax
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2009to Oct 2013
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years; < 80 years
- Left atrium =< 6.0 cm
- Documented persistent or longstanding persistent AF
- History of AF =< 10 years
- Scheduled for a concomitant cardiac procedure
- Coronary bypass surgery (CABG)
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- Mitral valve repair/replacement
- Aortic valve replacement
- ASD repair
- Tricuspid valve repair/replacement
- Myxoma
- Any combination of the above procedures
- Provided written informed consent
Who cannot join
- Left atrial size > 6.0 cm (pre-op TTE - parasternal 4 chamber view)
- History of AF > 10 years
- Left ventricular ejection fraction < 30%
- Pregnant or planning to become pregnant during study
- Co-morbid medical conditions that limit one year life expectancy
- History of coagulopathy
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- Patients who are contraindicated for anticoagulants(heparin, warfarin etc.)
- Previous cardiac surgery
- History of pericarditis
- Previous cerebrovascular accident (CVA)
- Patients who have active infection or sepsis
- Patients who have uncorrected reversible cause(s) of AF such as hyperthyroidism and electrolyte imbalance
- Patients who are being treated for ventricular arrhythmias
- Patients who have had a previous catheter ablation for AF (does not include ablation for Aflutter)
- Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment.
- Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baptist Memorial Hospital
Memphis, Tennessee, 38120
Venice Regional Medical Center
Venice, Florida, 34285-3298
About this study
Official title: Numeris-AF Tethered Coagulation System With VisiTrax Indicated For Treatment of Persistent and Longstanding Persistent Atrial Fibrillation
This is a multi center, non-randomized, prospective, open label, clinical trial evaluating the safety and efficacy of the nContact Surgical Numeris-AF Tethered Coagulation System when used to treat patients with persistent and longstanding persistent AF during concomitant cardiac surgery.
Read the detailed description
The purpose of this study is to determine the safety and efficacy of the Numeris-AF Tethered Coagulation System with VisiTrax when used to treat persistent and longstanding persistent Atrial Fibrillation(AF)during concomitant cardiac surgery.
- Conditions
- Atrial Fibrillation
- Being tested
- Numeris-AF Tethered Coagulation System with VisiTrax
- Keywords
- AF, atrial fibrillation, ablation, surgical ablation, afib, coagulation, RF, epicardial, Arrhythmias
- Medical subject headings
- Atrial Fibrillation, Thrombosis, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Numeris-AF Tethered Coagulation System with VisiTraxDevice
Also called RF Ablation, Coagulation of cardiac tissue, nContact Surgical
Surgical radiofrequency (RF) epicardial ablation using the nContact Numeris-AF Tethered Coagulation System
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | Not described Receives: Device: Numeris-AF Tethered Coagulation System with VisiTrax |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary effectiveness endpoint will be assessed as number of subjects free from AF and free of all Class I and III Anti Arrhythmic Drugs (AADs) through 9 months post procedure.
Measured: 9 months
Secondary outcomes (2)
Secondary effectiveness endpoint: Proportion of subjects free from AF regardless of their Class I and III AADs status through 9 months post procedure.
Measured: 9 months
Secondary effectiveness endpoint: Proportion of subjects free of AF/ AFL / AT and off all Class I and Class III AADs.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2009 (estimated)
- Study startOct 2009
- Primary completionJun 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- nContact Surgical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward Garrett, M.D., Principal investigator, Baptist Memorial Hospital - Memphis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950092
- Sponsor's protocol ID
- VAL-1116(C)
- Status last verified
- Sep 2013
- First submitted
- 29 Jul 2009
- Last updated
- 3 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Numeris-AF Tethered Coagulation System With VisiTrax Indicated For Treatment of Persistent and Longstanding Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00950092
- Acronym / sponsor ID
- VAL-1116(C)
- Conditions
- Atrial Fibrillation
- Keywords
- AF, atrial fibrillation, ablation, surgical ablation, afib, coagulation, RF, epicardial
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 5 participants (actual)
- Lead sponsor
- nContact Surgical Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 31 Jul 2009 (estimated)
- 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.
This is a multi center, non-randomized, prospective, open label, clinical trial evaluating the safety and efficacy of the nContact Surgical Numeris-AF Tethered Coagulation System when used to treat patients with persistent and longstanding persistent AF during concomitant cardiac surgery.
Detailed description
The purpose of this study is to determine the safety and efficacy of the Numeris-AF Tethered Coagulation System with VisiTrax when used to treat persistent and longstanding persistent Atrial Fibrillation(AF)during concomitant cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Device: Numeris-AF Tethered Coagulation System with VisiTrax |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age > 18 years; < 80 years
- Left atrium =< 6.0 cm
- Documented persistent or longstanding persistent AF
- History of AF =< 10 years
- Scheduled for a concomitant cardiac procedure
Key exclusion criteria (16 listed)
- Left atrial size > 6.0 cm (pre-op TTE - parasternal 4 chamber view)
- History of AF > 10 years
- Left ventricular ejection fraction < 30%
- Pregnant or planning to become pregnant during study
- Co-morbid medical conditions that limit one year life expectancy
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 |
|---|---|---|
| Numeris-AF Tethered Coagulation System with VisiTraxAlso: RF Ablation, Coagulation of cardiac tissue, nContact SurgicalSurgical radiofrequency (RF) epicardial ablation using the nContact Numeris-AF Tethered Coagulation System | Device | Treatment |
Primary outcome
The primary effectiveness endpoint will be assessed as number of subjects free from AF and free of all Class I and III Anti Arrhythmic Drugs (AADs) through 9 months post procedure.
Time frame: 9 months
2 secondary outcomes
Secondary effectiveness endpoint: Proportion of subjects free from AF regardless of their Class I and III AADs status through 9 months post procedure.
Time frame: 9 months
Secondary effectiveness endpoint: Proportion of subjects free of AF/ AFL / AT and off all Class I and Class III AADs.
Time frame: 9 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2014.
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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.
Edward Garrett, M.D. principal investigator
Baptist Memorial Hospital - Memphis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Numeris-AF Tethered Coagulation System with VisiTrax in people with Atrial Fibrillation, run by nContact Surgical Inc. at 2 sites in United States.
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 13 inclusion and 16 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: stopped early, as of the sponsor's last update on 3 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 was stopped early. Results are not available in the source record.
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?
The primary effectiveness endpoint will be assessed as number of subjects free from AF and free of all Class I and III Anti Arrhythmic Drugs (AADs) through 9 months post procedure. (time frame: 9 months). 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 3 Apr 2014.