- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05418725
Ground-Breaking Electroporation-based Intervention for PERSistent Atrial Fibrillation Treatment (BEAT PERS-AF) (BEAT PERS-AF)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pierre Jais, MD, PhD
- Phone Number: +33 5 57 65 64 71
- Email: pierre.jais@chu-bordeaux.fr
Study Contact Backup
- Name: Nicolas Derval, MD
- Email: nicolas.derval@chu-bordeaux.fr
Study Locations
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Graz, Austria
- Not yet recruiting
- Medical University of Graz
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Contact:
- Daniel Scherr, MD
- Email: daniel.scherr@medunigraz.at
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Bruges, Belgium
- Not yet recruiting
- AZ Sint-Jan Brugge-Oostende
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Contact:
- Sebastien Knecht, MD
- Email: sebastien.knecht@azsintjan.be
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Prague, Czechia
- Not yet recruiting
- Institute for Clinical and Experimental Medicine
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Contact:
- Josef Kautzner, MD
- Email: josef.kautzner@ikem.cz
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Prague, Czechia
- Not yet recruiting
- Homolka Hospital
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Contact:
- Petr Neuzil, MD
- Email: pneuzil@seznam.cz
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Pessac, France
- Recruiting
- CHU Bordeaux
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Contact:
- Nicolas Derval, MD
- Email: nicolas.derval@chu-bordeaux.fr
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Toulouse, France
- Not yet recruiting
- CHU Toulouse
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Contact:
- Philippe Maury, PD, PhD
- Email: maury.p@chu-toulouse.fr
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Toulouse, France
- Not yet recruiting
- Clinique Pasteur, Toulouse
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Contact:
- Serge Boveda, MD
- Email: sboveda@clinique-pasteur.com
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Bad Neustadt an der Saale, Germany
- Not yet recruiting
- Cardiovascular Center Bad Neustadt
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Contact:
- Thomas Deneke, MD
- Email: thomas.deneke@campus-nes.de
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Munich, Germany
- Not yet recruiting
- Deutsches Herzzentrum München
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Contact:
- Isabel Deisenhofer, MD
- Email: deisenhofer@dhm.mhn.de
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Patients with drug-resistant symptomatic persistent AF meeting all the following criteria:
- Persistent: continuous drug resistant AF that is sustained beyond 7 days (but less than 1 year).
- Frequency: At least one (1) documented episode by a recording such as ECG, EM, Holter monitor or telemetry strip within 6 months of enrolment.
- Drug failed: Failed AAD treatment, meaning therapeutic failure of at least one (1) AAD (Class I to IV) for efficacy and / or intolerance.
- Patients who are ≥ 18 and ≤ 75 years of age on the day of enrollment.
Patient who are willing and capable of:
- Providing informed consent to undergo study procedures AND
- Participating in all examinations and follow-up visits and tests associated with this clinical study.
- Patient having a smart phone compatible with the Event Monitor device.
- Highly effective contraception for women of childbearing potential.
- Effective oral anticoagulation >3 weeks prior to planned ablation procedure
- Patient affiliated to or beneficiary of national health security scheme for French participants.
Exclusion Criteria:
1. AF that is any of the following:
- Paroxysmal AF by diagnosis or that terminates spontaneously within 7 days of onset
- Secondary to electrolyte imbalance, thyroid disease, alcohol or other reversible / non-cardiac causes 2. Any of the following atrial conditions:
- Left atrial anteroposterior diameter ≥ 5.5 cm (by MRI, CT or TTE)
- Any prior atrial endocardial or epicardial ablation procedure, other than right sided cavotricuspid isthmus ablation or for right sided SVT
- Any prior atrial surgery
- Intra-atrial septal patch or interatrial shunt
- Atrial myxoma
- Current LA thrombus
- LA appendage closure, device or occlusion, past or anticipated
- Any PV abnormality, stenosis or stenting (common and middle PVs are admissible) 3. At any time, one (1) or more of the following cardiovascular procedures, implants or conditions:
a. Sustained ventricular tachycardia or any ventricular fibrillation b. Hemodynamically significant valvular disease: i. Valvular disease that is symptomatic ii. Valvular disease causing or exacerbating congestive heart failure iii. Aortic stenosis: if already characterized, valve area < 1.5cm or gradient > 20 mm Hg iv. Mitral stenosis: if already characterized, valve area < 1.5cm or gradient > 5 mm Hg v. Aortic or mitral regurgitation associated with abnormal LV function or hemodynamic measurements c. Hypertrophic cardiomyopathy d. Any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty e. Pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices f. Any inferior vena cava (IVC) filter, known inability to obtain vascular access or other contraindication to femoral access g. History of rheumatic fever h. History of congenital heart disease with any residual anatomic or conduction abnormality 4. Any of the following procedures, implants or conditions:
a. At baseline: i. New York Heart Association (NYHA) Class III/IV ii. Left ventricular ejection fraction (LVEF) < 40% iii. Symptomatic hypotension iv. Uncontrolled hypertension (SBP > 160 mmHg or DBP > 95 mmHg on two BP measurements at baseline assessment) v. Symptomatic resting bradycardia vi. Implantable loop recorder or insertable cardiac monitor, b. Within the 3 months preceding the Consent Date: i. Myocardial infarction ii. Unstable angina iii. Percutaneous coronary intervention iv. Heart failure hospitalization v. Pericarditis or symptomatic pericardial effusion vi. Gastrointestinal bleeding c. Within the 6 months preceding the Consent Date: i. Heart surgery ii. Stroke, TIA or intracranial bleeding iii. Any thromboembolic event iv. Carotid stenting or endarterectomy 5. Diagnosed disorder of blood clotting or bleeding diathesis 6. Contraindication to, or unwillingness to use, systemic anticoagulation 7. Contraindication to both CT and MRI 8. Sensitivity to contrast media not controllable by premedication 9. Women who are pregnant, lactating, or who are planning to become pregnant during the anticipated study period 10. Medical conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation, including but not limited to:
- Body Mass Index (BMI) > 40.0
- 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 requiring supplemental oxygen
- Renal insufficiency with an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant
- Active malignancy or history of treated malignancy within 24 months of enrollment (other than cutaneous basal cell or squamous cell carcinoma)
- Clinically significant gastrointestinal problems involving the esophagus or stomach including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal ulceration
- Active systemic infection
- COVID-19 disease
- Current confirmed, active COVID-19 disease ii. Current positive test for SARS-CoV-2 iii. Confirmed COVID-19 disease not clinically resolved at least 3 months prior to the Consent Date.
i. Other uncontrolled medical conditions that may modify device effect or increase risk, including uncontrolled diabetes mellitus (HgbA1c > 8.0% if test result already obtained), untreated obstructive sleep apnea or active alcohol abuse j. Predicted life expectancy less than one (1) year 11. Clinically significant psychological condition that in the Investigator's opinion would prohibit the subject's ability to meet the protocol requirements/ Patient under legal protection 12. Current or anticipated enrollment in any other clinical study. 13. Employees / family members of:
- FARAPULSE or any of its affiliates or contractors
- The Investigator, sub-Investigators, or their medical office or practice, or healthcare organizations at which study procedures may be performed.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: PEF Arm
PEF is a non-thermal ablation modality using extremely short high voltage pulses to induce cell death, with tissue selectivity, cardiomyocytes being much more sensitive to this energy than Phrenic nerve or Esophageal cells.
Energy (2000 V) will be delivered 8 times per vein with 2 different catheter configurations and rotations.
Linear lesion will be delivered using 8 deliveries using 2000 V at the posterior left atrium
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PVI and Linear lesion using PEF
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Active Comparator: Pulmonary vein isolation and linear lesion using Contact Force RF
The PVI strategy using RF is very standard.
The CARTO© platform will be used, with a contact force catheter (SmartTouch), aiming at an ablation index value of 300 to 400 on the posterior wall, and at least 500 on the anterior wall.
Power will be limited to 35/45 W, with a distance between consecutive deliveries of 6 mm or less (CLOSE protocol).
Linear lesion will be delivered at the posterior left atrium.
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PVI and Linear lesion using CFRF
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
proportion of subjects experiencing 1-year single-procedure clinical success
Time Frame: 1 year
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The Primary Efficacy Endpoint is the proportion of subjects experiencing 1-year single-procedure clinical success, defined as :
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
health-related quality of life:
Time Frame: 6 months, 1 year
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Health-related quality of life will be evaluated using the SF-12 questionnaire.
The SF-12 includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health.
Results are expressed in terms of two meta-scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
High score indicates better functioning
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6 months, 1 year
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AF-specific quality of life
Time Frame: 6 months, 1 year
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Improvement in AF-specific quality of life will be assessed using QualiTy-of-life (AFEQT) questionnaire.
Scores range from 0 to 100.
A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered)
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6 months, 1 year
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Death
Time Frame: 7 days, 1 year
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Proportion of participants with death
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7 days, 1 year
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Stroke
Time Frame: 7 days, 1 year
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Proportion of participants with
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7 days, 1 year
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Embolic events from arrhythmia,
Time Frame: 1 year
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Proportion of participants with embolic events from arrhythmia
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1 year
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Myocardial infarction
Time Frame: 7 days
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Proportion of participants with Myocardial infarction
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7 days
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Persistent diaphragmatic paralysis
Time Frame: 7 days
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Proportion of participants with Persistent diaphragmatic paralysis
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7 days
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Transient ischemic attack (TIA)
Time Frame: 7 days
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Proportion of participants with Transient ischemic attack (TIA)
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7 days
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Peripheral or organ thromboembolism
Time Frame: 7 days
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Proportion of participants with Peripheral or organ thromboembolism
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7 days
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Cardiac Tamponade / Perforation
Time Frame: 7 days
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Proportion of participants with Cardiac Tamponade / Perforation
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7 days
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Pericarditis
Time Frame: 7 days
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Proportion of participants with Pericarditis
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7 days
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Hospitalisation
Time Frame: 7 days
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Proportion of participants with Hospitalisation (initial or prolonged), excluding hospitalisation solely due to arrhythmia recurrence
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7 days
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Heart block
Time Frame: 7 days
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Proportion of participants with Heart block
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7 days
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Vascular access complications
Time Frame: 7 days
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Proportion of participants with Vascular access complications
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7 days
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Pulmonary vein stenosis (PVS)
Time Frame: 1 year
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Proportion of participants with Pulmonary vein stenosis (PVS)
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1 year
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Atrio-oesophageal fistula
Time Frame: 1 year
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Proportion of participants with Atrio-oesophageal fistula
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1 year
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Total ablation procedure duration
Time Frame: Baseline
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Index Ablation Procedure parameters: Total ablation procedure duration (in minutes), skin to skin
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Baseline
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Left atrial (LA) dwell time during ablation procedure
Time Frame: Baseline
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Index Ablation Procedure parameters: Left atrial (LA) dwell time, defined as the time (in minutes) transpiring from catheter entry to exit from the LA
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Baseline
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Total fluoroscopy time during ablation procedure
Time Frame: Baseline
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Index Ablation Procedure parameters: Total fluoroscopy time (in minutes), skin-to-skin
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Baseline
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PV diameter
Time Frame: 2 months
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Change in mean PV diameter 2 months
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2 months
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Incidence of acute vagal response during PVI
Time Frame: Baseline
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Incidence of acute vagal response during PVI
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Baseline
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proportion of subjects with 1-year multiple-procedures success
Time Frame: 1 year
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proportion of subjects with 1-year multiple-procedures success defined as the following up to 12 months following the index ablation procedure:
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1 year
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mean heart rate variability
Time Frame: 1 year
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Change in mean heart rate
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1 year
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heart rate variability
Time Frame: 1 year
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Change in heart rate
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1 year
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acute complete PVI with PEF
Time Frame: 1 year
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Proportion of participants with acute complete PVI with PEF
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1 year
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acute complete linear lesion with PEF
Time Frame: 1 year
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Proportion of participants with acute complete linear lesion with PEF
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1 year
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2021/62
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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