ट्रायल रडार AI | ||
|---|---|---|
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। | ||
A Global Study Comparing Pulsed Field Ablation With Electrographic Flow Mapping Versus Posterior Wall Ablation for Persistent Atrial Fibrillation (OPTIMIZE) 699
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.
- OPTIMIZE
- PF334
FARAPOINT
OptiMap
| प्रतिभागी समूह/शाखा | हस्तक्षेप/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. |
| परिणाम माप | माप विवरण | समय 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 |
| परिणाम माप | माप विवरण | समय 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 |
≥ 18 years of age, or older if required by local law
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
Willing and capable of providing informed consent
Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center
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
Any of the following atrial conditions:
- Left atrial anteroposterior diameter ≥ 5.5 cm, or if1 LA diameter not available, non-indexed volume >100 ml (physician note or imaging)
- Any prior left atrial ablation
- Any prior atrial surgery
- Current atrial myxoma
- Current left atrial thrombus
- Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)
Any of the following cardiovascular conditions:
History of sustained ventricular tachycardia or any ventricular fibrillation
Severe right ventricular dysfunction with documented echocardiography and/or hemodynamic data, per Investigator's discretion
AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
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
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
Hypertrophic or amyloid cardiomyopathy
Any IVC filter, known inability to obtain vascular access or other contraindication to femoral access
Awaiting cardiac transplantation or other planned cardiac surgery within the next 12 months
Severe right ventricular dysfunction with documented echocardiography and/or hemodynamic data.
Any of the following conditions at Baseline:
- Heart failure associated with NYHA Class III or IV
- Most recent documented LVEF < 40% within the previous 12 months
- Body Mass Index (BMI) > 45.0
- Known coagulopathy or bleeding disorder
- Contraindication to, or unwillingness to use systemic anticoagulation, or acceptable alternatives, pre-, intra- and post-procedure to achieve adequate anticoagulation
- Women who are confirmed to be pregnant or lactating at the time of the ablation procedure
- Severe lung disease, severe pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen
- Active malignancy (other than 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
- Known active systemic infection
- Untreated diagnosed obstructive sleep apnea with apnea hypopnea index classification of severe (>30 pauses per hour) as per the guidelines
- Predicted life expectancy less than one year per investigator medical judgement
- 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
- Required use of phosphodiesterase inhibitors within 24 hours of the ablation procedure
- 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
- CHA2DS2-VASc score ≥ 5
- Known allergic drug reaction to nitroglycerin (excluding hypotension)
- Unwillingness to receive, or unable to tolerate, a subcutaneous, chronically inserted LUX-Dx ICM device
Any of the following congenital conditions:
- Congenital heart disease with any clinically significant residual anatomic or conduction abnormality
- History of known congenital methemoglobinemia
- History of known G6PD deficiency
Any of the following conditions in the medical history:
- Solid organ or hematologic transplant, or currently being evaluated for a transplant
- Any prior history or current evidence of hemi-diaphragmatic paralysis or paresis
- Any documented history of Prinzmetal Angina or severe non-revascularizable coronary disease
- 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
- 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.
Any of the following events less than or equal to 90 days of the consent date:
- Myocardial infarction (MI), unstable angina or coronary intervention
- Any cardiac surgery
- Heart failure hospitalization
- Pericarditis or symptomatic pericardial effusion
- Gastrointestinal bleeding
- Stroke, TIA, or intracranial bleeding
- Any active non-neurologic thrombus and/or thromboembolic event
- Carotid stenting or endarterectomy
- Uncontrolled diabetes mellitus or a recorded HbA1c > 8.0%
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