RECRUITING

Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System

Conditions

Persistent Atrial Fibrillation Pulsed Field Ablation (PFA))Pulmonary Vein Isolation Recurrent Arrhythmia cavo-tricuspid isthmus (CTI)CTI dependent flutter Anti Arrhythmic Drugs (AAD)Atrial Flutter Atrial Tachycardia Atrial fibrillation Electrical cardioversion

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06-03

Study Completion:2028-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06735534

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. * 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	1. 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. 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

Inclusion Criteria

Exclusion 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.
* 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

1. 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.
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

Contacts and Locations

Study Contact

Erin Feddema

CONTACT

+1 (320)267 7589

erin.feddema@bsci.com

Kaitlyn Aldrich

CONTACT

+16515824790

kaitlyn.aldrich@bsci.com

Principal Investigator

Moussa Mansour,, MD

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Study Locations (Sites)

Arrhythmia Research Group-Research Facility

Jonesboro, Arkansas, 72401

United States

Collaborators and Investigators

Sponsor: Boston Scientific Corporation

Moussa Mansour,, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-03

Study Completion Date2028-01

Study Record Updates

Study Start Date2025-06-03

Study Completion Date2028-01

Terms related to this study

Keywords Provided by Researchers

Pulsed Field Ablation (PFA))
Pulmonary Vein Isolation
Recurrent Arrhythmia
cavo-tricuspid isthmus (CTI)
CTI dependent flutter
Anti Arrhythmic Drugs (AAD)
Atrial Flutter
Atrial Tachycardia
Atrial fibrillation
Electrical cardioversion

Additional Relevant MeSH Terms

Persistent Atrial Fibrillation