Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System
Purpose
The ReMATCH Study is a prospective, single arm, open label, multi-center, study utilizing the FARAPULSE PFA System, including the FARAWAVE and FARAPOINT PFA Catheters.
Condition
- Persistent Atrial Fibrillation
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- ≥ 18 years of age, or older if required by local law - Single previous AF ablation procedure for Paroxysmal Atrial Fibrillation (PAF) or Persistent AF (PersAF)that minimally included pulmonary vein isolation that occurred within 5 years prior to enrollment. - Documented (physician's note) diagnosis of PersAF either prior to the subject's Index Procedure OR development of PersAF after the Index Procedure. - Documented evidence of AF recurrence at least 60 days after the subject's Index Procedure, captured by any regulatory cleared rhythm monitoring device. OR - If diagnosed with PersAF prior to the Index Procedure, documented recurrence of AF or atypical AFL at least 60 days after the Index Procedure, captured by any regulatory cleared rhythm monitoring device. - 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
Exclusion Criteria
- Atrial exclusions - Any of the following atrial conditions: 1. Left atrial anteroposterior diameter ≥ 5.5 cm, or if LA diameter not available, non-indexed volume >100 ml (physician note or imaging) 2. Current atrial myxoma 3. Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible) 4. Current left atrial thrombus 2. Cardiovascular exclusions - Any of the following CV conditions: 1. History of sustained ventricular tachycardia or any ventricular fibrillation 2. AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes 3. Current or anticipated pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices, or implantable loop recorder, other than LUX-Dx. Prior interatrial baffle, atrial septal patch, atrial septal defect closure device, patent foramen ovale occluder, Amulet devices, or other left atrial appendage closure device if implanted within 90 days of enrollment 4. Presence of any of the following: - Any prosthetic heart valve, ring or repair - Moderate to severe mitral valve stenosis - More than moderate mitral regurgitation (>3+) - Moderate to severe aortic stenosis 5. Hypertrophic cardiomyopathy 6. Any IVC filter, known inability to obtain vascular access or other contraindication to femoral access 7. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months 8. 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. Documented LVEF < 40% as documented within the previous 12 months 3. 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 4. Body Mass Index (BMI) >45.0 5. CHA2DS2-VASc score ≥5 4. Any of the following events within 90 Days of the Consent Date: 1. Coronary disease: Myocardial infarction (MI), unstable or Prinzmetal angina or coronary intervention within 90 days of consent or any documented history of severe non-revascularize coronary disease 2. Cardiac surgery: Any cardiac surgery 3. Heart failure hospitalization: Heart failure hospitalization 4. Pericardium: Pericarditis or symptomatic pericardial effusion 5. GI bleeding: Gastrointestinal bleeding 6. Neurovascular event: Stroke, TIA, or intracranial bleeding 7. Thromboembolism: Any active non-neurologic thrombus and/or thromboembolic event 8. Carotid intervention: Carotid stenting or endarterectomy 9. Diabetes: Uncontrolled diabetes mellitus or a recorded HgbA1c > 8.0% 5. Any of the following congenital conditions: 1. Congenital heart disease: Congenital heart disease with any clinically significant residual anatomic or conduction abnormality 2. Methemoglobinemia: History of known congenital methemoglobinemia 3. G6PD deficiency: History of known G6PD deficiency 6. Any of the following conditions: 1. Transplantation: Solid organ or hematologic transplant, or currently being evaluated for a transplant 2. Diaphragmatic abnormality: Any prior history or current evidence of hemi-diaphragmatic paralysis or paresis 3. Pulmonary: Severe lung disease, severe pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen 4. Renal: 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. Malignancy: Active malignancy at enrolment (other than squamous cell carcinoma) 6. Gastrointestinal: Clinically significant gastrointestinal problems involving the esophagus or stomach including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal ulceration 7. Infections: Active systemic infection 8. Sleep apnea: Untreated diagnosed obstructive sleep apnea with apnea hypopnea index classification of severe (>30 pauses per hour) 9. Medication use: Required use of phosphodiesterase inhibitors within 24 hours of the ablation procedure 10. Nitroglycerin intolerance: Known allergic drug reaction to nitroglycerin (excluding hypotension) 11. Hematologic condition: Known coagulopathy or bleeding disorder (e.g. von Willebrand disease, hemophilia) 12. Contraindication to anticoagulation: Contraindication to, or unwillingness to use, systemic anticoagulation, or acceptable alternatives, pre-, intra- and post-procedure to achieve adequate anticoagulation. 13. Pregnancy: Women of childbearing potential who are pregnant, lactating, not using medical birth control or who are planning to become pregnant during the anticipated study period 14. General health conditions: Health conditions 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. 15. LUX-Dx ICM intolerance: Unwillingness to receive, or unable to tolerate, a subcutaneous, chronically inserted LUX-Dx ICM device 16. Participation in another trial: 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. 17. Life expectancy: Predicted life expectancy less than three (3) years
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other Single Arm Prospective |
Repeat Ablation of Persistent Atrial Fibrillation, including Mitral Isthmus Catheter Ablation, with the FARAPULSE Pulsed Field Ablation System. |
|
Recruiting Locations
Mobile Infirmary Medical Center
Mobile 4076598, Alabama 4829764 36607
Mobile 4076598, Alabama 4829764 36607
Arrhythmia Research Group-Research Facility
Jonesboro 4116834, Arkansas 4099753 72401
Jonesboro 4116834, Arkansas 4099753 72401
University of Southern California Hospital
Los Angeles 5368361, California 5332921 90033
Los Angeles 5368361, California 5332921 90033
HCA Florida Mercy Hospital
Miami 4164138, Florida 4155751 33133
Miami 4164138, Florida 4155751 33133
Emory University Hospital
Atlanta 4180439, Georgia 4197000 30322
Atlanta 4180439, Georgia 4197000 30322
Memorial Health University Medical Center
Savannah 4221552, Georgia 4197000 31404
Savannah 4221552, Georgia 4197000 31404
Johns Hopkins Hospital
Baltimore 4347778, Maryland 4361885 21287
Baltimore 4347778, Maryland 4361885 21287
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
Boston 4930956, Massachusetts 6254926 02114
Southcoast Physicians Group
Fall River 4936159, Massachusetts 6254926 02720
Fall River 4936159, Massachusetts 6254926 02720
Virtua Health Inc.
Marlton 4502911, New Jersey 5101760 08053
Marlton 4502911, New Jersey 5101760 08053
Bethesda North Hospital
Cincinnati 4508722, Ohio 5165418 45242
Cincinnati 4508722, Ohio 5165418 45242
Ohio State University Medical Center
Columbus 4509177, Ohio 5165418 43210
Columbus 4509177, Ohio 5165418 43210
Trident Medical Center
Charleston 4574324, South Carolina 4597040 29406
Charleston 4574324, South Carolina 4597040 29406
Texas Cardiac Arrhythmia Research
Austin 4671654, Texas 4736286 78705
Austin 4671654, Texas 4736286 78705
Christus Trinity Mother Frances Health System
Tyler 4738214, Texas 4736286 75701
Tyler 4738214, Texas 4736286 75701
Sentara Norfolk General Hospital
Norfolk 4776222, Virginia 6254928 23507
Norfolk 4776222, Virginia 6254928 23507
More Details
- Status
- Recruiting
- Sponsor
- Boston Scientific Corporation
Detailed Description
The goal of this study is to evaluate the safety and effectiveness of using the FARAWAVE™ and FARAPOINT™ pulsed field ablation (PFA) catheters for re-treatment of persistent atrial fibrillation (PersAF) after a failed initial procedure.