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क्लिनिकल ट्रायल NCT07187115 (OPTIMIZE) के लिए एट्रियल फिब्रिलेशन (AF), Persistant Atrial Fibrillation वर्तमान में भर्ती जारी है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें।
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य

A Global Study Comparing Pulsed Field Ablation With Electrographic Flow Mapping Versus Posterior Wall Ablation for Persistent Atrial Fibrillation (OPTIMIZE) 699

भर्ती जारी
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT07187115 (OPTIMIZE) एक हस्तक्रियात्मक चिकित्सकीय अध्ययन है जो एट्रियल फिब्रिलेशन (AF), Persistant Atrial Fibrillation से जुड़ा हुआ है। परीक्षण वर्तमान में भर्ती जारी चल रहा है। इसकी शुरुआत 7 नवंबर 2025 को हुई थी, और इसमें कुल 699 प्रतिभागियों के नामांकन की योजना है। Boston Scientific इस परीक्षण का नेतृत्व कर रहे हैं और इसके 1 दिसंबर 2030 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 2 मार्च 2026 को अंतिम बार अपडेट की गई थी
संक्षिप्त सारांश
The purpose of this study is to establish the safety of the pulsed field ablation (PFA) therapy of Pulmonary Veins and Electrographic Flow (EGF) identified extra-PV sources of atrial fibrillation (PVI + EGF ablation of sources) and to demonstrate its non-inferiority in effectiveness compared to PFA of Pulmonary Veins and LA Posterior Wall (PVI+ PWA) in the treatment of de novo symptomatic drug-refractory persistent a...और दिखाएँ
आधिकारिक शीर्षक

A Global Randomized Trial Comparing Pulsed Field Ablation of Pulmonary Veins Plus Extra-PV Sources Utilizing Electrographic Flow Mapping Versus Pulmonary Veins Plus Posterior Wall in Persistent Atrial Fibrillation Patients.

स्वास्थ्य स्थितियां
एट्रियल फिब्रिलेशन (AF)Persistant Atrial Fibrillation
अन्य अध्ययन आईडी
  • OPTIMIZE
  • PF334
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2025-11-07
अंतिम अद्यतन प्रकाशित
2026-03-02
अध्ययन की समाप्ति तिथि (अनुमानित)
2030-12
नामांकन (अनुमानित)
699
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
निर्दिष्ट नहीं
स्थिति
भर्ती जारी
प्रमुख शब्द
FARAPULSE
FARAPOINT
OptiMap
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
कोई नहीं (खुला लेबल)
समूह/हस्तक्षेप
प्रतिभागी समूह/शाखाहस्तक्षेप/उपचार
सक्रिय तुलना समूहControl Arm
PVI + PWA: The Control Arm, consisting of subjects undergoing PVI + PWA. PWA will be performed adjunctive to PVI per protocol Section 10.8.10. Following confirmation of PWA, EGF mapping will be performed in the LA and RA, while Investigators, lab/nursing staff, and research personnel are blinded to the EGF maps.
OptiMap System (non-ablative)
An electrophysiology mapping system that uses a proprietary algorithm to analyze electrogram signals.
FARAPULSE Pulsed Field Ablation (PFA) System and Opal HDx Mapping System
All subjects will undergo electroanatomical mapping of the entire left atrium with the FARAWAVE NAV Catheter and Opal HDx Mapping System, followed by PFA PVI with the FARAWAVE NAV PFA Catheter, per the instructions of use.
प्रयोगात्मकTreatment Arm
PVI + EGF source(s) ablation: The Treatment Arm, consisting of subjects undergoing PVI + EGF source(s) ablation. Adjunctive to PVI, the EGF-identified active sources above threshold will be ablated per protocol Section 10.8.11. If following PVI, a narrow channel that is approximately ≤ 1 cm is identified in the LAPW, ablation may be performed using the FARAPOINT Catheter.
FARAPOINT Pulsed Field Ablation System
A component of the FARAPULSE Pulsed Field Ablation (PFA) System and is a multi-electrode bidirectional, deflectable percutaneous catheter, an adjunctive catheter designed to create focal-type lesions for the creation of an ablation line between the inferior vena cava and the tricuspid valve.
OptiMap System (non-ablative)
An electrophysiology mapping system that uses a proprietary algorithm to analyze electrogram signals.
FARAPULSE Pulsed Field Ablation (PFA) System and Opal HDx Mapping System
All subjects will undergo electroanatomical mapping of the entire left atrium with the FARAWAVE NAV Catheter and Opal HDx Mapping System, followed by PFA PVI with the FARAWAVE NAV PFA Catheter, per the instructions of use.
प्राथमिक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
Primary Safety Endpoint
The primary safety endpoint is the rate of ITT subjects in the PVI+EGF arm with one or more of the following serious device- or procedure-related Composite Adverse Events (CAEs) assessed through 60 days following the Index Procedure.
60 Days
Primary Effectiveness Endpoint
The primary effectiveness endpoint is the rate of ITT subjects with treatment success in the PVI+EGF arm vs. the PVI+PWA control arm through Day 365, aiming to demonstrate non-inferiority of PVI+EGF compared to the PVI+PWA control.
365 Days
द्वितीयक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
Secondary Effectiveness Endpoint
The secondary effectiveness endpoint is a test for superiority in Treatment Success between the Treatment Arm and the Control Arm. The test for superiority will only be conducted if the non-inferiority test for the PEE is passed and the result favors the Treatment Arm.
365 Days
भागीदारी सहायक
पात्रता मानदंड

अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
18 Years
अध्ययन के लिए पात्र लिंग
सभी
  1. ≥ 18 years of age, or older if required by local law

  2. Have symptomatic drug-refractory1, persistent AF2, confirmed by both:

    • Documentation, such as physician note, of persistent continuous AF for > 7 days and ≤ 365 days and the arrhythmia symptoms

    • Documentation, within 180 days of enrollment date of either:

      • A 24-hour continuous ECG recording confirming continuous AF or
      • Two (2) ECGs (from any regulatory cleared rhythm monitoring device) showing continuous AF taken at least 7 days apart
  3. Willing and capable of providing informed consent

  4. Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center

  5. Willing to receive LUX-Dx insertable cardiac monitor (ICM) during the study or already has a LUX-Dx ICM that was inserted ≤ 6 months (i.e., within 180 days) of consent, and willing to comply to the LUX-Dx Latitude Clarity transmission instructions

  1. Any of the following atrial conditions:

    1. Left atrial anteroposterior diameter ≥ 5.5 cm, or if1 LA diameter not available, non-indexed volume >100 ml (physician note or imaging)
    2. Any prior left atrial ablation
    3. Any prior atrial surgery
    4. Current atrial myxoma
    5. Current left atrial thrombus
    6. Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)
  2. Any of the following cardiovascular conditions:

    1. History of sustained ventricular tachycardia or any ventricular fibrillation

    2. Severe right ventricular dysfunction with documented echocardiography and/or hemodynamic data, per Investigator's discretion

    3. AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes

    4. Cardiac devices and implants:

      • Current or anticipated pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices
      • Implantable loop recorder, other than LUX-Dx
      • Interatrial baffle, patent foramen ovale or atrial septal defect closure device or patch
      • Any left atrial appendage closure or occlusion device
    5. Presence of any of the following valvular conditions:

      • Any prosthetic heart valve, stenotic valves, ring or repair
      • Moderate to severe mitral valve stenosis
      • More than moderate mitral regurgitation
    6. Hypertrophic or amyloid cardiomyopathy

    7. Any IVC filter, known inability to obtain vascular access or other contraindication to femoral access

    8. Awaiting cardiac transplantation or other planned cardiac surgery within the next 12 months

    9. Severe right ventricular dysfunction with documented echocardiography and/or hemodynamic data.

  3. Any of the following conditions at Baseline:

    1. Heart failure associated with NYHA Class III or IV
    2. Most recent documented LVEF < 40% within the previous 12 months
    3. Body Mass Index (BMI) > 45.0
    4. Known coagulopathy or bleeding disorder
    5. Contraindication to, or unwillingness to use systemic anticoagulation, or acceptable alternatives, pre-, intra- and post-procedure to achieve adequate anticoagulation
    6. Women who are confirmed to be pregnant or lactating at the time of the ablation procedure
    7. Severe lung disease, severe pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen
    8. Active malignancy (other than squamous cell carcinoma)
    9. Clinically significant gastrointestinal problems involving the esophagus or stomach including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal ulceration
    10. Known active systemic infection
    11. Untreated diagnosed obstructive sleep apnea with apnea hypopnea index classification of severe (>30 pauses per hour) as per the guidelines
    12. Predicted life expectancy less than one year per investigator medical judgement
    13. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the Sponsor to determine eligibility
    14. Required use of phosphodiesterase inhibitors within 24 hours of the ablation procedure
    15. Uncontrolled hypertension (SBP > 160 mmHg or DBP > 95 mmHg on two (2) BP measurements at baseline assessment not attributable to white coat syndrome per Investigator opinion
    16. CHA2DS2-VASc score ≥ 5
    17. Known allergic drug reaction to nitroglycerin (excluding hypotension)
    18. Unwillingness to receive, or unable to tolerate, a subcutaneous, chronically inserted LUX-Dx ICM device
  4. Any of the following congenital conditions:

    1. Congenital heart disease with any clinically significant residual anatomic or conduction abnormality
    2. History of known congenital methemoglobinemia
    3. History of known G6PD deficiency
  5. Any of the following conditions in the medical history:

    1. Solid organ or hematologic transplant, or currently being evaluated for a transplant
    2. Any prior history or current evidence of hemi-diaphragmatic paralysis or paresis
    3. Any documented history of Prinzmetal Angina or severe non-revascularizable coronary disease
    4. Renal insufficiency if an estimated glomerular filtration rate (eGFR) is < 30 mL / min / 1.73 m2, or with any history of renal dialysis or renal transplant
    5. Any other general health condition that, in the investigator's medical opinion, 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.
  6. Any of the following events less than or equal to 90 days of the consent date:

    1. Myocardial infarction (MI), unstable angina or coronary intervention
    2. Any cardiac surgery
    3. Heart failure hospitalization
    4. Pericarditis or symptomatic pericardial effusion
    5. Gastrointestinal bleeding
    6. Stroke, TIA, or intracranial bleeding
    7. Any active non-neurologic thrombus and/or thromboembolic event
    8. Carotid stenting or endarterectomy
    9. Uncontrolled diabetes mellitus or a recorded HbA1c > 8.0%
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अध्ययन केंद्रीय संपर्क
संपर्क: Jackie Lin, +16123608544, [email protected]
संपर्क: Karin Froidcourt, +32 471 63 6566, [email protected]
37 6 देशों में अध्ययन स्थान

Alabama

Grandview Medical Center, Birmingham, Alabama, 35243, United States
अभी भर्ती शुरू नहीं

Arizona

Mercy Gilbert Medical Center, Gilbert, Arizona, 85297, United States
अभी भर्ती शुरू नहीं
Banner University Medical Center, Phoenix, Arizona, 85008, United States
अभी भर्ती शुरू नहीं

Arkansas

Arrhythmia Research Group, Jonesboro, Arkansas, 72401, United States
Tiffany Warhurst, संपर्क, [email protected]
Devi Nair, MD, मुख्य अन्वेषक
भर्ती जारी

California

Alta Bates Summit Medical Center, Oakland, California, 94609, United States
अभी भर्ती शुरू नहीं
Stanford University Medical Center, Palo Alto, California, 94304, United States
अभी भर्ती शुरू नहीं
Pacific Heart Institute, Santa Monica, California, 90404, United States
अभी भर्ती शुरू नहीं

Georgia

Piedmont Athens Regional, Athens, Georgia, 30606, United States
अभी भर्ती शुरू नहीं
Emory University Hospital, Atlanta, Georgia, 30308, United States
अभी भर्ती शुरू नहीं

Idaho

St. Luke's Idaho Cardiology Associates, Boise, Idaho, 83702, United States
अभी भर्ती शुरू नहीं

Illinois

Endeavor Hospital, Glenview, Illinois, 60026, United States
अभी भर्ती शुरू नहीं

Iowa

Mercy Hospital Medical Center, West Des Moines, Iowa, 50266, United States
अभी भर्ती शुरू नहीं

Kentucky

Baptist Health Lexington, Lexington, Kentucky, 40503, United States
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Massachusetts

Massachusetts General Hospital, Boston, Massachusetts, 02114, United States
अभी भर्ती शुरू नहीं

Michigan

William Beaumont Hospital, Royal Oak, Michigan, 48073, United States
अभी भर्ती शुरू नहीं

Minnesota

St. Mary's Duluth Clinic Regional Heart Center, Duluth, Minnesota, 55805, United States
Kaitlyn Tollerud, संपर्क
अभी भर्ती शुरू नहीं

New York

Mount Sinai Medical Center, New York, New York, 10029, United States
अभी भर्ती शुरू नहीं
Good Samaritan - Suffern, Suffern, New York, 10901, United States
अभी भर्ती शुरू नहीं

North Carolina

Mission Hospital, Asheville, North Carolina, 28801, United States
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Ohio

Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States
Raquel Rozich, संपर्क, [email protected]
Ayman Hussein, MD, मुख्य अन्वेषक
भर्ती जारी
Ohio State University Medical Center, Columbus, Ohio, 43210, United States
अभी भर्ती शुरू नहीं
OhioHealth Riverside Methodist Hospital, Columbus, Ohio, 43214, United States
Reem Bekheet, संपर्क
अभी भर्ती शुरू नहीं

Oregon

Sacred Heart Medical Center at Riverbend, Springfield, Oregon, 97477, United States
वापस लिया गया

Pennsylvania

Presbyterian University of Pennsylvania Medical Center, Pittsburgh, Pennsylvania, 15213, United States
अभी भर्ती शुरू नहीं
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, 15213, United States
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Texas

Texas Cardiac Arrhythmia Research Foundation, Austin, Texas, 78705, United States
Debbie Cardinal, संपर्क, [email protected]
Andrea Natale, MD, मुख्य अन्वेषक
भर्ती जारी
Christus Trinity Mother Frances Health System, Tyler, Texas, 75701, United States
Adrian Maples, संपर्क, [email protected]
Stanislav Weiner, मुख्य अन्वेषक
भर्ती जारी

Virginia

Inova Fairfax Hospital, Falls Church, Virginia, 22042, United States
वापस लिया गया
Sentara Norfolk General Hospital, Norfolk, Virginia, 23507, United States
अभी भर्ती शुरू नहीं
Onze Lieve Vrouw Ziekenhuis, Aalst, 9300, Belgium
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Hartcentrum Hasselt Jessa Ziekenhuis Campus Virga Jesse, Hasselt, 3500, Belgium
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Centre Hôpital Universitaire Rouen, Hôpital Charles Nicolle, Rouen, 76000, France
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MVZ CCB Frankfurt und Main-Taunus GbR, Frankfurt, 60431, Germany
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St. Antonius Ziekenhuis, Nieuwegein, 3435, Netherlands
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Erasmus MC - University Medical Center Rotterdam, Rotterdam, 3015, Netherlands
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Catalonia

Hospital Clinic de Barcelona, Barcelona, Catalonia, 08036, Spain
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Navarre

Clinica Universidad de Navarra, Pamplona, Navarre, 31008, Spain
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