Paroxysmal Atrial FibrillationCAP STOPS AFNCT01103674
Safety and Efficacy Study of the Combined Ablation Procedure to Treat Paroxysmal Atrial Fibrillation
A study testing Numeris®-AF Guided Coagulation System with VisiTrax® in people with Paroxysmal Atrial Fibrillation, run by nContact Surgical Inc. at 2 sites in United States.
Trial summary
This is a multi-center, prospective, open label, feasibility clinical study,evaluating the safety and efficacy of the combined ablation procedure for the treatment of symptomatic paroxysmal atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- Numeris®-AF Guided Coagulation System with VisiTrax®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2010to Jul 2012
- 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 less than or equal to 6.5 cm (TTE)
- Symptomatic paroxysmal AF
- Provided written informed consent
- Refractory to at least one AAD (class I, II, III or IV)
Who cannot join
- Patients requiring concomitant surgery
- Left ventricular ejection fraction < 30%
- Pregnant or planning to become pregnant during study
- Co-morbid medical conditions that limit one year life expectancy
- Measured left ventricular wall thickness > 1.5 cm
- History of coagulopathy
Show all 18Show fewer
- Previous cardiac surgery
- Right ventricular outflow tract obstruction
- History of pericarditis
- Previous cerebrovascular accident (CVA), excluding fully resolved TIA
- Patients who have severe chronic obstructive pulmonary disease (COPD)
- Patients who have an active infection or sepsis
- Patients who have uncorrected reversible cause(s) of AF
- Patients who are contraindicated for anticoagulants
- Patients who are being treated for arrhythmias other than AF
- Patients who have had any previous AF or left atrial catheter ablation
- 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
Texas Cardiac Arrhythmia Institute, St. David's Hospital
Austin, Texas, 78705
Baptist Memorial Hospital
Memphis, Tennessee, 38120
About this study
Official title: Feasibility Study For Safety and Efficacy Evaluation Of The Combined Ablation Procedure For The Treatment Of Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation
This is a multi-center, prospective, open label, feasibility clinical study,evaluating the safety and efficacy of the combined ablation procedure for the treatment of symptomatic paroxysmal atrial fibrillation.
Read the detailed description
The purpose of this feasibility study is to evaluate the safety and efficacy of the epicardial / endocardial combined procedure for the treatment of drug refractory symptomatic Paroxysmal Atrial Fibrillation (AF) patients, using the nContact Numeris®-AF Guided Coagulation System with VisiTrax® epicardially and the Biosense Webster NaviStar® ThermoCool® Diagnostic/Ablation deflectable Tip Catheter in conjunction with the Carto Navigation System endocardially.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- Numeris®-AF Guided Coagulation System with VisiTrax®
- Keywords
- Paroxysmal Atrial Fibrillation, AF, Atrial Fibrillation, RF ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Numeris®-AF Guided Coagulation System with VisiTrax®Device
Combined epicardial / endocardial procedure using the Numeris®-AF Guided Coagulation System with VisiTrax® epicardially and the Biosense Webster ThermoCool Catheter in conjunction with the Carto Navigation System endocardially.
| Study group | Role | What they receive |
|---|---|---|
| Numeris-AF Guided Coagulation System | Other | Not described Receives: Device: Numeris®-AF Guided Coagulation System with VisiTrax® |
What is being measured
The primary outcome is the main question the study is designed to answer.
AF free off all Class I and III Anti Arrhythmic Drugs (AADs).
The primary efficacy data will be an evaluation of the number of subjects free from AF and free of all Class I and III Anti Arrhythmic Drugs (AADs) from 3 months through 12 months post procedure.
Measured: 12 months
Secondary outcomes (1)
AF free regardless of the Class I and III AADs status
The secondary efficacy data will be an evaluation of the number of subjects free from AF regardless of their Class I and III AADs status from 3 months through 12 months post procedure.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2012
- Study completionJul 2012
Why it stopped: enrollment challenges, only one patient enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- nContact Surgical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rodney Horton, MD, Principal investigator, Texas Cardiac Arrhythmia Institute, St. David's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103674
- Sponsor's protocol ID
- VAL-1150
- Acronym
- CAP STOPS AF
- Status last verified
- Jul 2012
- First submitted
- 13 Apr 2010
- 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
- Feasibility Study For Safety and Efficacy Evaluation Of The Combined Ablation Procedure For The Treatment Of Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01103674
- Acronym / sponsor ID
- CAP STOPS AF / VAL-1150
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- Paroxysmal Atrial Fibrillation, AF, Atrial Fibrillation, RF ablation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: enrollment challenges, only one patient enrolled
- Enrolment
- 1 participants (actual)
- Lead sponsor
- nContact Surgical Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 15 Apr 2010 (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, prospective, open label, feasibility clinical study,evaluating the safety and efficacy of the combined ablation procedure for the treatment of symptomatic paroxysmal atrial fibrillation.
Detailed description
The purpose of this feasibility study is to evaluate the safety and efficacy of the epicardial / endocardial combined procedure for the treatment of drug refractory symptomatic Paroxysmal Atrial Fibrillation (AF) patients, using the nContact Numeris®-AF Guided Coagulation System with VisiTrax® epicardially and the Biosense Webster NaviStar® ThermoCool® Diagnostic/Ablation deflectable Tip Catheter in conjunction with the Carto Navigation System endocardially.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Numeris-AF Guided Coagulation System | Other | Device: Numeris®-AF Guided 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 (5 listed)
- Age > 18 years; < 80 years
- Left atrium less than or equal to 6.5 cm (TTE)
- Symptomatic paroxysmal AF
- Provided written informed consent
- Refractory to at least one AAD (class I, II, III or IV)
Key exclusion criteria (18 listed)
- Patients requiring concomitant surgery
- Left ventricular ejection fraction < 30%
- Pregnant or planning to become pregnant during study
- Co-morbid medical conditions that limit one year life expectancy
- Measured left ventricular wall thickness > 1.5 cm
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 Guided Coagulation System with VisiTrax®Combined epicardial / endocardial procedure using the Numeris®-AF Guided Coagulation System with VisiTrax® epicardially and the Biosense Webster ThermoCool Catheter in conjunction with the Carto Navigation System endocardially. | Device | Numeris-AF Guided Coagulation System |
Primary outcome
AF free off all Class I and III Anti Arrhythmic Drugs (AADs).
Time frame: 12 months
The primary efficacy data will be an evaluation of the number of subjects free from AF and free of all Class I and III Anti Arrhythmic Drugs (AADs) from 3 months through 12 months post procedure.
1 secondary outcome
AF free regardless of the Class I and III AADs status
Time frame: 12 months
Results and safety
The study was stopped early (reason given: enrollment challenges, only one patient enrolled). 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.
Rodney Horton, MD principal investigator
Texas Cardiac Arrhythmia Institute, St. David's Medical Center
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 Guided Coagulation System with VisiTrax® in people with Paroxysmal 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 5 inclusion and 18 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 (reason given: enrollment challenges, only one patient enrolled). 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?
AF free off all Class I and III Anti Arrhythmic Drugs (AADs). (time frame: 12 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.