Paroxysmal Atrial FibrillationEFFICAS IINCT02131337
TactiCath® Prospective Effectiveness Pilot Study
A study testing Electrophysiology study in people with Paroxysmal Atrial Fibrillation, run by Abbott Medical Devices at 3 sites in 2 countries.
Trial summary
EFFICAS II proposes to test the hypothesis that treatment efficacy correlates to contact force parameters applied for pulmonary vein isolation (PVI) during AF 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?
- Electrophysiology study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Dec 2010to Oct 2011
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is at least 18 years of age but not over 75 years of age
- Patient has at least one episode of sustained (>30s) paroxysmal atrial fibrillation documented by 12-lead ECG, holter monitor, transtelephonic event monitor, telemetry strip, or Pacemaker respectively implantable cardioverter defibrillator (ICD) within 12 months prior to enrolment
- Patient has symptomatic paroxysmal atrial fibrillation (PAF) refractory or intolerant to at least one Class I-IV anti-arrhythmic drug
- Patient is willing and capable of complying with the study protocol requirements, including the specified follow-up scheme
- Patient provides written informed consent prior to enrolment in the study
Who cannot join
- Not adhering to inclusion criteria
- Active systemic infection
- Recent (within 3 months) cardiac events including myocardial infarction, acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery
- Reversible causes of Arrhythmia including thyroid disorders, acute alcohol intoxication, recent (less than 3 months) major surgical procedures
- Patient has a left atrial diameter > 5.0 cm
- Patient has persistent or long-standing persistent atrial fibrillation (AF)
Show all 22Show fewer
- Left ventricular ejection fraction < 35%
- New York Heart Association (NYHA) class III or IV
- Previous left atrial heart ablation procedure, either surgical or catheter ablation
- Patient has an intracardiac mural thrombus or has had a ventriculotomy or atriotomy
- Patient has moderate or severe structural heart disease as demonstrated by transthoracic or trans-esophageal echocardiogram of all four chambers of the heart (ventricular dysfunction or valve disease)
- Tricuspid or mitral valve replacement or repair
- If female of childbearing potential - pregnant or breastfeeding
- Patient has a bleeding diathesis or suspected pro-coagulant state
- Patient has contraindication to long-term antithromboembolic therapy (e. g. acetylsalicylic acid, heparin, warfarin)
- Presence of condition that precludes appropriate vascular access
- Heart disease in which corrective surgery is anticipated within 6 months
- Renal failure requiring dialysis
- Patient has a known sensitivity to contrast media (if needed during the procedure) that cannot adequately be controlled with pre-medication (or totally excluded)
- Patient has other anatomic or co-morbid conditions that, in the Investigator's opinion, could limit the patient's ability to participate in the study or to comply with follow-up requirements, or impact the scientific soundness of the study results
- Patient is currently participating in another clinical trial
- Patient is unlikely to survive over one year
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
Official title: Efficacy Study on Atrial Fibrillation Percutaneous Catheter Ablation With Contact Force Support 2
EFFICAS II proposes to test the hypothesis that treatment efficacy correlates to contact force parameters applied for pulmonary vein isolation (PVI) during AF ablation.
Read the detailed description
EFFICAS II is a single-arm, prospective study, where the operator will have access to contact force information and use it actively to optimize the ablation result and adapting power if necessary. The endpoint will correlate contact force parameters initially applied in PV and 3 months PV isolation status, and compare results to those of EFFICAS I.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- Electrophysiology study
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrophysiology studyOther
after 3 months to check for pulmonary vein isolation (PVI) status
| Study group | Role | What they receive |
|---|---|---|
| Contact force lesions | Other | Not described Receives: Other: Electrophysiology study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of pulmonary vein isolation (PVI) gaps per vein
Number of gaps in EFFICAS 2 is lower than in EFFICAS 1 and Contact force in EFFICAS 2 has reduced variability than in EFFICAS 1. Confounding parameters such as lesion continuity will be determined for the remaining gaps in EFFICAS 2.
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 posted6 May 2014 (estimated)
- Study startDec 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.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Endosense
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131337
- Sponsor's protocol ID
- EFFICAS II Version B
- Acronym
- EFFICAS II
- Status last verified
- Jan 2019
- First submitted
- 28 Apr 2014
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study on Atrial Fibrillation Percutaneous Catheter Ablation With Contact Force Support 2
- ClinicalTrials.gov ID
- NCT02131337
- Acronym / sponsor ID
- EFFICAS II / EFFICAS II Version B
- Conditions
- Paroxysmal Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- Endosense
- Study start
- Dec 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 6 May 2014 (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.
EFFICAS II proposes to test the hypothesis that treatment efficacy correlates to contact force parameters applied for pulmonary vein isolation (PVI) during AF ablation.
Detailed description
EFFICAS II is a single-arm, prospective study, where the operator will have access to contact force information and use it actively to optimize the ablation result and adapting power if necessary. The endpoint will correlate contact force parameters initially applied in PV and 3 months PV isolation status, and compare results to those of EFFICAS I.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contact force lesions | Other | Other: Electrophysiology study |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is at least 18 years of age but not over 75 years of age
- Patient has at least one episode of sustained (>30s) paroxysmal atrial fibrillation documented by 12-lead ECG, holter monitor, transtelephonic event monitor, telemetry strip, or Pacemaker respectively implantable cardioverter defibrillator (ICD) within 12 months prior to enrolment
- Patient has symptomatic paroxysmal atrial fibrillation (PAF) refractory or intolerant to at least one Class I-IV anti-arrhythmic drug
- Patient is willing and capable of complying with the study protocol requirements, including the specified follow-up scheme
- Patient provides written informed consent prior to enrolment in the study
Key exclusion criteria (22 listed)
- Not adhering to inclusion criteria
- Active systemic infection
- Recent (within 3 months) cardiac events including myocardial infarction, acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery
- Reversible causes of Arrhythmia including thyroid disorders, acute alcohol intoxication, recent (less than 3 months) major surgical procedures
- Patient has a left atrial diameter > 5.0 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 |
|---|---|---|
| Electrophysiology studyafter 3 months to check for pulmonary vein isolation (PVI) status | Other | Contact force lesions |
Primary outcome
Number of pulmonary vein isolation (PVI) gaps per vein
Time frame: 3 months
Number of gaps in EFFICAS 2 is lower than in EFFICAS 1 and Contact force in EFFICAS 2 has reduced variability than in EFFICAS 1. Confounding parameters such as lesion continuity will be determined for the remaining gaps in EFFICAS 2.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrophysiology study in people with Paroxysmal Atrial Fibrillation, run by Abbott Medical Devices at 3 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 5 inclusion and 22 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 Jan 2019. 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 Czechia, 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of pulmonary vein isolation (PVI) gaps per vein (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 30 Jan 2019.