Paroxysmal Atrial FibrillationPEFCATIINCT04170608
PEFCATII Expanded Safety and Feasibility Study of the FARAPULSE Endocardial Multi Ablation System to Treat Paroxysmal Atrial Fibrillation
A study testing FARAPULSE Endocardial Multi Ablation System in people with Paroxysmal Atrial Fibrillation, run by Boston Scientific Corporation at 2 sites in 2 countries.
Trial summary
PEFCAT II: Expanded Safety and Feasibility Study of the FARAPULSE Endocardial Multi Ablation System to Treat Paroxysmal Atrial Fibrillation 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?
- FARAPULSE Endocardial Multi Ablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 18 Oct 2019to 7 Dec 2020
- Phase
- Interventional
- 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
Who may be able to join
- Study subjects are required to meet all the following inclusion criteria to participate in this study:
- Patients with documented drug-resistant symptomatic PAF meeting all three of the following criteria:
- Confirmed AF: Documentation must include a recording such as ECG, transtelephonic monitor (TTM), Holter monitor, implanted devices, or telemetry strip, recorded within one year prior to enrollment and showing at least 30 seconds of AF.
- Frequent AF, defined as ≥ 2 episodes within 6 months of enrollment.
- Failed atrial fibrillation drug (AFD) treatment, meaning therapeutic failure of at least one AFD (class I - IV) for efficacy and / or intolerance.
- Patients who are ≥ 18 and ≤ 75 years of age on the day of enrollment.
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- Patient participation requirements:
- Lives locally.
- Is willing and capable of providing Informed Consent to undergo study procedures.
- Is willing to participate in all examinations and follow-up visits and tests associated with this clinical study.
Who cannot join
- EXCLUSION CRITERIA: Subjects will be excluded from participating in this study if they meet any one of the following exclusion criteria:
- Atrial fibrillation that is any of the following:
- Persistent (by diagnosis or duration > 7 days)
- Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible / non-cardiac causes
- Requires ≥ 4 cardioversions in the preceding 12 months
- Left atrial anteroposterior diameter ≥ 5.0 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT)
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- Any of the following cardiac procedures, implants or conditions:
- Clinically significant arrhythmias other than AF, AFL or AT
- Hemodynamically significant valvular disease
- Prosthetic heart valve
- NYHA Class III or IV CHF
- Previous endocardial or epicardial ablation or surgery for AF
- Atrial or ventricular septal defect closure
- Atrial myxoma
- Left atrial appendage device or occlusion
- Pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices
- Significant or symptomatic hypotension
- Bradycardia or chronotropic incompetence
- History of pericarditis
- History of rheumatic fever
- History of congenital heart disease with any residual anatomic or conduction abnormality
- Any of the following within 3 months of enrollment:
- Myocardial infarction
- Unstable angina
- Percutaneous coronary intervention
- Heart surgery (e.g. coronary artery bypass grafting, ventriculotomy, atriotomy)
- Heart failure hospitalization
- Stroke or TIA
- Clinically significant bleeding
- Pericarditis or pericardial effusion
- Left atrial thrombus
- History of blood clotting or bleeding abnormalities
- Contraindication to, or unwillingness to use, systemic anticoagulation
- Contraindications to CT or MRI
- Sensitivity to contrast media not controlled by premedication
- Women of childbearing potential who are pregnant, lactating or not using birth control
- Medical conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or confound data or its interpretation, including but not limited to:
- Body mass index (BMI) > 40
- Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
- Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspnea
- Renal insufficiency with an estimated creatinine clearance < 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant
- Active malignancy or history of treated cancer within 24 months of enrollment
- Clinically significant gastrointestinal problems involving the esophagus, stomach and/or untreated acid reflux
- Clinically significant infection
- Predicted life expectancy less than one year
- Clinically significant psychological condition that in the investigator's opinion would prohibit the subject's ability to meet the protocol requirements.
- Current or anticipated enrollment in any other clinical study.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: PEFCAT II: Expanded Safety and Feasibility Study of the FARAPULSE Endocardial Multi Ablation System to Treat Paroxysmal Atrial Fibrillation
PEFCAT II: Expanded Safety and Feasibility Study of the FARAPULSE Endocardial Multi Ablation System to Treat Paroxysmal Atrial Fibrillation
Read the detailed description
This is a prospective, multi-center, safety and feasibility study. Subjects will undergo percutaneous PEF ablation for pulmonary vein isolation and at the clinical discretion of the investigator receive PEF ablation of additional arrhythmogenic locations. Subjects will be followed at 30 days, 75 days, 6 months and 12 months for adverse events, recurrence of arrhythmia after a 90-day Blanking Period and other relevant outcome measures.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- FARAPULSE Endocardial Multi Ablation System
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FARAPULSE Endocardial Multi Ablation SystemDevice
Ablation using the FARAPULSE Endocardial Multi Ablation System
| Study group | Role | What they receive |
|---|---|---|
| FARAPULSE Endocardial Ablation | Experimental | Ablation using the FARAPULSE Endocardial Multi Ablation System Receives: Device: FARAPULSE Endocardial Multi Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Number of Participants With Prespecified Primary Safety Events Within 30 Days of Index Procedure.
Number of patients with death, MI, diaphragmatic paralysis, stroke/TIA, thromboemolism, pericarditis, tamponade/perforation, vascular access complications, hospitalization, heart block, PV stenosis, atrioesophageal fistula.
Measured: 30 Days
Feasibility: Acute Key Procedural Success
The primary feasibility endpoint for this study is the proportion of subjects that achieve Acute Procedural Success (APS) defined as the percutaneous endocardial creation of a complete, electrically isolating set of lesions around the ostia of the pulmonary veins (PVI) using the FARAPULSE Endocardial Multi Ablation System during the first Procedure, as clinically assessed by entrance and/or exit block performed ≥ 20 minutes after the last PVI lesion is made.
Measured: Index Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start18 Oct 2019
- Primary completion7 Dec 2020
- Study completion7 Dec 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Petr Neuzil, Principal investigator, Nemocnice Na Homolce
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170608
- Sponsor's protocol ID
- CS0571
- Acronym
- PEFCATII
- Status last verified
- May 2022
- First submitted
- 17 Oct 2019
- Last updated
- 4 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Reddy VY, Dukkipati SR, Neuzil P, Anic A, Petru J, Funasako M, Cochet H, Minami K, Breskovic T, Sikiric I, Sediva L, Chovanec M, Koruth J, Jais P. Pulsed Field Ablation of Paroxysmal Atrial Fibrillation: 1-Year Outcomes of IMPULSE, PEFCAT, and PEFCAT II. JACC Clin Electrophysiol. 2021 May;7(5):614-627. doi: 10.1016/j.jacep.2021.02.014. Epub 2021 Apr 28.
PubMed 33933412
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEFCAT II: Expanded Safety and Feasibility Study of the FARAPULSE Endocardial Multi Ablation System to Treat Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04170608
- Acronym / sponsor ID
- PEFCATII / CS0571
- Conditions
- Paroxysmal Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- 7 Dec 2020 (actual)
- Study completion
- 7 Dec 2020 (actual)
- First posted
- 20 Nov 2019 (actual)
- Results
- Posted 4 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PEFCAT II: Expanded Safety and Feasibility Study of the FARAPULSE Endocardial Multi Ablation System to Treat Paroxysmal Atrial Fibrillation
Detailed description
This is a prospective, multi-center, safety and feasibility study. Subjects will undergo percutaneous PEF ablation for pulmonary vein isolation and at the clinical discretion of the investigator receive PEF ablation of additional arrhythmogenic locations. Subjects will be followed at 30 days, 75 days, 6 months and 12 months for adverse events, recurrence of arrhythmia after a 90-day Blanking Period and other relevant outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FARAPULSE Endocardial Ablation | Experimental | Device: FARAPULSE Endocardial Multi Ablation SystemAblation using the FARAPULSE Endocardial Multi Ablation System |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Study subjects are required to meet all the following inclusion criteria to participate in this study:
- Patients with documented drug-resistant symptomatic PAF meeting all three of the following criteria:
- Patients who are ≥ 18 and ≤ 75 years of age on the day of enrollment.
- Patient participation requirements:
Key exclusion criteria (47 listed)
- EXCLUSION CRITERIA: Subjects will be excluded from participating in this study if they meet any one of the following exclusion criteria:
- Atrial fibrillation that is any of the following:
- Left atrial anteroposterior diameter ≥ 5.0 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT)
- Any of the following cardiac procedures, implants or conditions:
- Any of the following within 3 months of enrollment:
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 |
|---|---|---|
| FARAPULSE Endocardial Multi Ablation SystemAblation using the FARAPULSE Endocardial Multi Ablation System | Device | FARAPULSE Endocardial Ablation |
Primary outcome
Safety: Number of Participants With Prespecified Primary Safety Events Within 30 Days of Index Procedure.
Time frame: 30 Days
Number of patients with death, MI, diaphragmatic paralysis, stroke/TIA, thromboemolism, pericarditis, tamponade/perforation, vascular access complications, hospitalization, heart block, PV stenosis, atrioesophageal fistula.
Feasibility: Acute Key Procedural Success
Time frame: Index Procedure
The primary feasibility endpoint for this study is the proportion of subjects that achieve Acute Procedural Success (APS) defined as the percutaneous endocardial creation of a complete, electrically isolating set of lesions around the ostia of the pulmonary veins (PVI) using the FARAPULSE Endocardial Multi Ablation System during the first Procedure, as clinically assessed by entrance and/or exit block performed ≥ 20 minutes after the last PVI lesion is made.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33933412Reddy VY, Dukkipati SR, Neuzil P, Anic A, Petru J, Funasako M, Cochet H, Minami K, Breskovic T, Sikiric I, Sediva L, Chovanec M, Koruth J, Jais P. Pulsed Field Ablation of Paroxysmal Atrial Fibrillation: 1-Year Outcomes of IMPULSE, PEFCAT, and PEFCAT II. JACC Clin Electrophysiol. 2021 May;7(5):614-627. doi: 10.1016/j.jacep.2021.02.014. Epub 2021 Apr 28.
- Individual participant dataSharing planned: No
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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.
Petr Neuzil principal investigator
Nemocnice Na Homolce
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FARAPULSE Endocardial Multi Ablation System in people with Paroxysmal Atrial Fibrillation, run by Boston Scientific Corporation 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?
The sponsor lists 10 inclusion and 47 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 4 May 2022. 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 Croatia, Czechia. 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?
Yes. Results are posted in the registry (first posted 4 May 2022). 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?
Safety: Number of Participants With Prespecified Primary Safety Events Within 30 Days of Index Procedure. (time frame: 30 Days). The study lists 2 primary outcomes in all. 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 NCT04170608, which also lists 1 linked publication.
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 4 May 2022.