Paroxysmal Atrial FibrillationPhase 4En-GARDENCT01057394
Post-Market Randomized Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation
A Phase 4 study testing Endoscopically guided PVI Ablation and RF PVI Ablation in people with Paroxysmal Atrial Fibrillation, run by CardioFocus at 2 sites in 2 countries.
Trial summary
To compare the safety and chronic Pulmonary Vein isolation of 2 ablation types. 1. visually guided ablation (VGA) using the EAS-AC and 2. radiofrequency ablation Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- Endoscopically guided PVI Ablation and RF PVI Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2009to Jun 2011
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- Symptomatic, Paroxysmal Atrial Fibrillation (AF)
- 18 to 75 Years of age
- Generally good overall health as determined by multiple criteria
- Willing to participate in a study
- Others
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Czechia1 site
Institute for Clinical and Experimental Medicine (IKEM)
Prague, 140 21
About this study
Official title: Post-Market Randomized Controlled Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation GuideD by Electroanatomical Mapping to Achieve Permanent Pulmonary Vein Isolation (En-GARDE)
To compare the safety and chronic Pulmonary Vein isolation of 2 ablation types.
- visually guided ablation (VGA) using the EAS-AC and
- radiofrequency ablation
Read the detailed description
The goal of the study was to compare two interventions, visually-guided endoscopic ablation to standard-of-care radiofrequency (RF) ablation. The study was terminated early by the Sponsor for business reasons before any participants were randomized or treated with RF ablation.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- Endoscopically guided PVI Ablation, RF PVI Ablation
- Keywords
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopically guided PVI AblationDevice
Endoscopically Guided Ablation using the EAS-AC
RF PVI AblationDevice
Radiofrequency ablation
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency Ablation | Active comparator | PVI using RF ablation Receives: Device: RF PVI Ablation |
| Visually Guided Ablation | Experimental | PVI using visually guided ablation with an endoscopic ablation system Receives: Device: Endoscopically guided PVI Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Permanent Pulmonary Vein Isolation of EAS-AC Compared to EAM Guided Radiofrequency Ablation
Number of initially isolated pulmonary veins that remain isolated at a 3 month remapping. The unit of measure is treated pulmonary veins (PVs).
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: Sponsor stopped study for business reasons; not for clinical or clinical outcomes reasons.
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- CardioFocus
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vivek Reddy, MD, Principal investigator, The Mount Sinai Hospital, New York City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057394
- Sponsor's protocol ID
- 25-2758
- Acronym
- En-GARDE
- Status last verified
- Jul 2016
- First submitted
- 26 Jan 2010
- Last updated
- 1 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Randomized Controlled Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation GuideD by Electroanatomical Mapping to Achieve Permanent Pulmonary Vein Isolation (En-GARDE)
- ClinicalTrials.gov ID
- NCT01057394
- Acronym / sponsor ID
- En-GARDE / 25-2758
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- Atrial Fibrillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor stopped study for business reasons; not for clinical or clinical outcomes reasons.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- CardioFocusIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 27 Jan 2010 (estimated)
- Results
- Posted 1 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the safety and chronic Pulmonary Vein isolation of 2 ablation types.
- visually guided ablation (VGA) using the EAS-AC and
- radiofrequency ablation
Detailed description
The goal of the study was to compare two interventions, visually-guided endoscopic ablation to standard-of-care radiofrequency (RF) ablation. The study was terminated early by the Sponsor for business reasons before any participants were randomized or treated with RF ablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency Ablation | Active comparator | Device: RF PVI AblationPVI using RF ablation |
| Visually Guided Ablation | Experimental | Device: Endoscopically guided PVI AblationPVI using visually guided ablation with an endoscopic ablation system |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Endoscopically guided PVI AblationEndoscopically Guided Ablation using the EAS-AC | Device | Visually Guided Ablation |
| RF PVI AblationRadiofrequency ablation | Device | Radiofrequency Ablation |
Primary outcome
Rate of Permanent Pulmonary Vein Isolation of EAS-AC Compared to EAM Guided Radiofrequency Ablation
Time frame: 3 Months
Number of initially isolated pulmonary veins that remain isolated at a 3 month remapping. The unit of measure is treated pulmonary veins (PVs).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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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.
Vivek Reddy, MD principal investigator
The Mount Sinai Hospital, New York City
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Endoscopically guided PVI Ablation and RF PVI Ablation in people with Paroxysmal Atrial Fibrillation, run by CardioFocus at 2 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?
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 1 Aug 2016. 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 Czechia, Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2016). 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?
Rate of Permanent Pulmonary Vein Isolation of EAS-AC Compared to EAM Guided Radiofrequency Ablation (time frame: 3 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 1 Aug 2016.