FARAPULSE パルスフィールドアブレーションシステムを使用した、僧帽弁峡カテーテルアブレーションを含む持続性心房細動の反復アブレーション (ReMATCH)
ReMATCH 研究は、FARAWAVE および FARAPOINT PFA カテーテルを含む FARAPULSE PFA システムを利用した、前向き、シングルアーム、オープンラベル、多施設の研究です。
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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究場所
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Alabama
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Mobile、Alabama、アメリカ、36607
- Mobile Infirmary Medical Center
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Arkansas
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Jonesboro、Arkansas、アメリカ、72401
- Arrhythmia Research Group-Research Facility
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California
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Los Angeles、California、アメリカ、90033
- University of Southern California Hospital
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Oxnard、California、アメリカ、93030
- St. John's Regional Medical Center
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Stanford、California、アメリカ、94305
- Stanford University Medical Center
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Colorado
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Littleton、Colorado、アメリカ、80120
- South Denver Cardiology Associates, PC
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Florida
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Miami、Florida、アメリカ、33133
- HCA Florida Mercy Hospital
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Naples、Florida、アメリカ、34102
- Naples Comprehensive Health
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Orlando、Florida、アメリカ、32803
- AdventHealth Orlando-Hospital
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Tampa、Florida、アメリカ、33606
- Tampa General Hospital
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Tampa、Florida、アメリカ、33613
- AdventHealth Tampa-Hospital
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Georgia
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Atlanta、Georgia、アメリカ、30322
- Emory University Hospital
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Macon、Georgia、アメリカ、32201
- Atrium Health Navicent The Medical Center
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Savannah、Georgia、アメリカ、31404
- Memorial Health University Medical Center
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Idaho
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Boise、Idaho、アメリカ、83712
- St. Luke's Boise Medical Center
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Illinois
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Oak Lawn、Illinois、アメリカ、60453
- Advocate Christ Medical Center-Hospital
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Maryland
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Baltimore、Maryland、アメリカ、21287
- Johns Hopkins Hospital
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Massachusetts
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Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital
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Fall River、Massachusetts、アメリカ、02720
- Southcoast Physicians Group
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Michigan
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Royal Oak、Michigan、アメリカ、48073
- William Beaumont Hospital-Hospital
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New Hampshire
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Lebanon、New Hampshire、アメリカ、03756
- Dartmouth Hitchcock Medical Center
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New Jersey
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Marlton、New Jersey、アメリカ、08053
- Virtua Health Inc.
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New Mexico
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Albuquerque、New Mexico、アメリカ、87102
- Lovelace Medical Center
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New York
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Manhasset、New York、アメリカ、11030
- Northwell Health
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New York、New York、アメリカ、10065
- Weill Cornell Medical University
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Ohio
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Cincinnati、Ohio、アメリカ、45242
- Bethesda North Hospital
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Columbus、Ohio、アメリカ、43210
- Ohio State University Medical Center
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Oklahoma
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Tulsa、Oklahoma、アメリカ、74104
- Oklahoma Heart Institute
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South Carolina
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Charleston、South Carolina、アメリカ、29406
- Trident Medical Center
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Texas
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Austin、Texas、アメリカ、78705
- Texas Cardiac Arrhythmia Research
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Tyler、Texas、アメリカ、75701
- Christus Trinity Mother Frances Health System
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Utah
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Salt Lake City、Utah、アメリカ、84124
- St. Mark's Hospital
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Virginia
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Norfolk、Virginia、アメリカ、23507
- Sentara Norfolk General Hospital
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Melbourne、オーストラリア
- The Alfred Hospital
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New South Wales
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New Lambton Heights、New South Wales、オーストラリア、606-8507
- John Hunter Hospital
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Westmead、New South Wales、オーストラリア、2145
- Westmead Hospital
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Queensland
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Brisbane、Queensland、オーストラリア、4001
- St. Andrew's War Memorial Hospital
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Victoria
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Clayton、Victoria、オーストラリア、3168
- Victorian Heart Hospital
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Parkville、Victoria、オーストラリア、3050
- The Royal Melbourne Hospital
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Taipei、台湾
- National Taiwan University Hospital
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Taipei、台湾
- Taipei Veterans General Hospital
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参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- ≥ 18 years of age, or older if required by local law
- Single previous endocardial AF ablation procedure for PAF or PersAF that minimally included pulmonary vein isolation
- 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 symptomatic 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 symptomatic 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:
a. Left atrial anteroposterior diameter ≥ 5.5 cm, or if LA diameter not available, non-indexed volume >100 ml (physician note or imaging) b. Current atrial myxoma c. Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible) d. Current left atrial thrombus
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Cardiovascular exclusions - Any of the following CV conditions:
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History of sustained ventricular tachycardia or any ventricular fibrillation
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AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
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Current or anticipated implantable cardioverter defibrillator, cardiac resynchronization therapy devices, or implantable loop recorders, other than LUX-Dx. Patients with a pacemaker are permitted; however, pacemaker-dependent patients are excluded.
Prior interatrial baffle, atrial septal patch, atrial septal defect closure device, patent foramen ovale occluder Left atrial appendage closure devices are excluded, with the exception of WATCHMAN. WATCHMAN is excluded if implanted within 90 days of enrollment
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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
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Hypertrophic cardiomyopathy
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Any IVC filter, known inability to obtain vascular access or other contraindication to femoral access
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Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
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Severe right ventricular dysfunction with documented echocardiography and/or hemodynamic data.
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Any of the following conditions at baseline:
- Heart failure associated with NYHA Class III or IV
- Documented LVEF < 40% as documented within the previous 12 months
- 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
- Body Mass Index (BMI) >45.0
- CHA2DS2-VASc score ≥5
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Any of the following events within 90 Days of the Consent Date:
- 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
- Cardiac surgery: Any cardiac surgery
- Heart failure hospitalization: Heart failure hospitalization
- Pericardium: Pericarditis or symptomatic pericardial effusion
- GI bleeding: Gastrointestinal bleeding
- Neurovascular event: Stroke, TIA, or intracranial bleeding
- Thromboembolism: Any active non-neurologic thrombus and/or thromboembolic event
- Carotid intervention: Carotid stenting or endarterectomy
- Diabetes: Uncontrolled diabetes mellitus or a recorded HgbA1c > 8.0%
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Any of the following congenital conditions:
- Congenital heart disease: Congenital heart disease with any clinically significant residual anatomic or conduction abnormality
- Methemoglobinemia: History of known congenital methemoglobinemia
- G6PD deficiency: History of known G6PD deficiency
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Any of the following conditions:
- Transplantation: Solid organ or hematologic transplant, or currently being evaluated for a transplant
- Diaphragmatic abnormality: Any prior history or current evidence of hemi-diaphragmatic paralysis or paresis.
Pulmonary: Severe lung disease, severe pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen d. 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 e. Malignancy: Active malignancy (other than squamous cell carcinoma) f. 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 g. Infections: Active systemic infection h. Required use of phosphodiesterase inhibitors within 24 hours of the ablation procedure i. Nitroglycerin intolerance: Known allergic drug reaction to nitroglycerin (excluding hypotension) j. Hematologic condition: Known coagulopathy or bleeding disorder (e.g. von Willebrand disease, hemophilia) k. Contraindication to anticoagulation: Contraindication to, or unwillingness to use, systemic anticoagulation, or acceptable alternatives, pre-, intra- and post-procedure to achieve adequate anticoagulation.
l. 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 m. 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.
n. LUX-Dx ICM intolerance: Unwillingness to receive, or unable to tolerate, a subcutaneous, chronically inserted LUX-Dx ICM device o. 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.
p. Life expectancy: Predicted life expectancy less than one (1) year
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
他の：Single Arm Prospective
Repeat Ablation of Persistent Atrial Fibrillation, including Mitral Isthmus Catheter Ablation, with the FARAPULSE Pulsed Field Ablation System. |
The FARAPULSE™ Pulsed Field Ablation System is indicated for the treatment of symptomatic atrial fibrillation. The FARAWAVE Catheter is indicated for the isolation of pulmonary veins and posterior wall in the treatment of drug-refractory, recurrent, symptomatic paroxysmal and persistent atrial fibrillation. The FARAWAVE Catheter is also indicated for the for the isolation of pulmonary veins and posterior wall in the treatment of persistent atrial fibrillation as an alternative to anti-arrhythmic drug (AAD) therapy as an initial rhythm control strategy. The FARAPOINT™ PFA Catheter is indicated for use as an adjunctive device for 1) the creation of an ablation line between the inferior vena cava and the tricuspid valve and/or 2) Mitral Isthmus, when the FARAWAVE Catheter is used in the endocardial treatment of persistent atrial fibrillation (episode duration no greater than 12 months). |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Primary safety endpoint rate
時間枠：60 days
|
The primary safety endpoint (PSE) is the proportion of Treatment subjects with one or more device or procedure-related Composite Serious Adverse Events (CSAEs) following the Repeat Ablation Procedure. |
60 days
|
|
The primary effectiveness endpoint is the proportion of Treatment subjects with Acute Procedural Success.
時間枠：24 hours
|
The proportion of Treatment Subjects with confirmed electrical block across all anatomical locations ablated with the investigational system only (Acute Procedural Success). |
24 hours
|
協力者と研究者
捜査官
捜査官
- 主任研究者：Moussa Mansour,, MD、Massachusetts General Hospital
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
その他の研究ID番号
- PF313
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。