Paroxysmal Atrial FibrillationPhase 3NCT00958165

Clinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic AF

A Phase 3 study testing CardioFocus EAS-AC in people with Paroxysmal Atrial Fibrillation, run by CardioFocus at 3 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine the safety and effectiveness of the endoscopic ablation system - adaptive contact (EAS-AC) in treated paroxysmal atrial fibrillation (PAF) with pulmonary vein isolation (PVI). Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Paroxysmal Atrial Fibrillation
What is being tested?: CardioFocus EAS-AC
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 81 participants
Where: 3 sitesGermany
Study dates: Aug 2009to May 2012
Phase: Phase 3
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Symptomatic, Paroxysmal atrial fibrillation (AF)
18 to 70 years of age
Failure of at least one AAD
Others

Who cannot join

Generally good overall health as determined by multiple criteria
Willing to participate in a study
Others

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

Cardioangiologisches Centrum Bethanien - CCB
Frankfurg, 60431
St. Georg Hosptial
Hamburg, 20099
Universität Leipzig - Herzzentrum
Leipzig, 04289

Other trials in Germany

About this study

Official title: Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CFEAS- AC) for the Treatment of Symptomatic Atrial Fibrillation

Conditions: Paroxysmal Atrial Fibrillation
Being tested: CardioFocus EAS-AC
Keywords: Treatment of PAF using EAS-AC
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CardioFocus EAS-ACDevice
PVI for PAF

Study groups in NCT00958165
Study group	Role	What they receive
EAS-AC	Experimental	PVI with EAS-AC Receives: Device: CardioFocus EAS-AC

What is being measured

The primary outcome is the main question the study is designed to answer.

Chronic Effectiveness in Treating PAF as Demonstrated by no AF Recurrences After the Blanking Period and During the 12-month Follow-up Period.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2009May 2012

First posted13 Aug 2009 (estimated)
Study startAug 2009
Primary completionMar 2012
Study completionMay 2012

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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00958165
Sponsor's protocol ID: 25-2738
Status last verified: Jul 2016
First submitted: 12 Aug 2009
Last updated: 30 Aug 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
RecruitingObservational study
A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation
Atrial Fibrillation
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation
Not yet recruitingObservational study
Catheter Ablation Using a Novel Navigation and Imaging System
Paroxysmal Atrial Fibrillation

All Paroxysmal Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CFEAS- AC) for the Treatment of Symptomatic Atrial Fibrillation
ClinicalTrials.gov ID: NCT00958165
Acronym / sponsor ID: 25-2738
Conditions: Paroxysmal Atrial Fibrillation
Keywords: Treatment of PAF using EAS-AC
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: CardioFocusIndustry (pharma, biotech, devices)
Study start: Aug 2009
Primary completion: Mar 2012 (actual)
Study completion: May 2012 (actual)
First posted: 13 Aug 2009 (estimated)
Results: Posted 27 Jul 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
EAS-AC	Experimental	Device: CardioFocus EAS-ACPVI with EAS-AC

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Symptomatic, Paroxysmal atrial fibrillation (AF)
18 to 70 years of age
Failure of at least one AAD
Others

Key exclusion criteria (3 listed)

Generally good overall health as determined by multiple criteria
Willing to participate in a study
Others

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
CardioFocus EAS-ACPVI for PAF	Device	EAS-AC

Primary outcome

Chronic Effectiveness in Treating PAF as Demonstrated by no AF Recurrences After the Blanking Period and During the 12-month Follow-up Period.
Time frame: 12 months

Results and safety

Results posted to the registry on 27 Jul 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
EAS-AC	81	67

Primary outcome: Chronic Effectiveness in Treating PAF as Demonstrated by no AF Recurrences After the Blanking Period and During the 12-month Follow-up Period.

Time frame: 12 months. Number. Unit: Successful participants

Measure	EAS-AC n = 67
Value	42

Population analysed: Of the 72 enrolled and treated participants, 67 were evaluable for the chronic effectiveness endpoint.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EAS-AC	10 of 72 (13.9%)	0 of 72 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Paroxysmal Atrial Fibrillation

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
RecruitingObservational study
A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation
Atrial Fibrillation
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation
Not yet recruitingObservational study
Catheter Ablation Using a Novel Navigation and Imaging System
Paroxysmal Atrial Fibrillation

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.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CardioFocus EAS-AC in people with Paroxysmal Atrial Fibrillation, run by CardioFocus at 3 sites in Germany.

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 3 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 30 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 3 sites in Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 27 Jul 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?

Chronic Effectiveness in Treating PAF as Demonstrated by no AF Recurrences After the Blanking Period and During the 12-month Follow-up Period. (time frame: 12 months). 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 NCT00958165.

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 30 Aug 2016.