HFrEF における CCM と ICD デバイスの組み合わせの評価 (INTEGRA-D)
心不全および駆出率の低下を有する被験者に対する心臓収縮性調節と植込み型除細動器の併用装置の安全性と有効性の評価
The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D System (the "CCM-D System") can safely and effective convert induced ventricular fibrillation (VF) and spontaneous ventricular tachycardia and/or ventricular fibrillation (VT/VF) episodes in subjects with Stage C or D heart failure who remain symptomatic despite being on guideline-directed medical therapy (GDMT), are not indicated for cardiac resynchronization therapy (CRT), and have heart failure with reduced left ventricular ejection fraction (LVEF ≤40%).
Eligible subjects will be implanted with the CCM-D System. A subset of subjects will be induced into ventricular fibrillation "on the table" in the implant procedure room. During the follow-up period, inappropriate shock rate and device-related complications will be evaluated. The follow-up period is expected to last at least two years.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Arizona
-
Glendale、Arizona、アメリカ、85306
- Phoenix Heart
-
Mesa、Arizona、アメリカ、85208
- Southwest Cardiovascular Associates
-
Mesa、Arizona、アメリカ、85206
- CardioVascular Associates of Mesa
-
Phoenix、Arizona、アメリカ、85016
- Arizona Heart Rhythm
-
Phoenix、Arizona、アメリカ、85032
- CVC Cardiovascular Consultants
-
Phoenix、Arizona、アメリカ、85306
- Phoenix Heart
-
Scottsdale、Arizona、アメリカ、85258
- Honor Health
-
-
California
-
Los Angeles、California、アメリカ、90033
- University of Southern California
-
Los Angeles、California、アメリカ、90048
- Cedars Sinai Medical Center
-
-
Connecticut
-
Hartford、Connecticut、アメリカ、06102
- Hartford HealthCare
-
-
Florida
-
Fort Lauderdale、Florida、アメリカ、33316
- Broward Health Medical Center
-
Miami、Florida、アメリカ、33173
- Baptist Health South Florida
-
Miami Beach、Florida、アメリカ、33140
- Mount Sinai Medical Center Miami Beach
-
Orlando、Florida、アメリカ、32803
- Advent Health Orlando
-
-
Iowa
-
West Des Moines、Iowa、アメリカ、50266
- Iowa Heart Center
-
-
Kansas
-
Kansas City、Kansas、アメリカ、66103
- University of Kansas Medical Center
-
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Kentucky
-
Lexington、Kentucky、アメリカ、40503
- Baptist Health Lexington
-
-
Massachusetts
-
Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital
-
-
Missouri
-
Kansas City、Missouri、アメリカ、64111
- Saint Luke's Hospital
-
St Louis、Missouri、アメリカ、63136
- St. Louis Heart and Vascular
-
St Louis、Missouri、アメリカ、63106
- St. Louis VA
-
-
New Jersey
-
Browns Mills、New Jersey、アメリカ、08015
- Deborah Heart and Lung Center
-
Cherry Hill、New Jersey、アメリカ、08034
- Virtua
-
Hackensack、New Jersey、アメリカ、07601
- Hackensack University Medical Center
-
Haddon Heights、New Jersey、アメリカ、08035
- The Heart House - Cardiovascular Associates of the Delaware Valley
-
Newark、New Jersey、アメリカ、07103
- Rutgers New Jersey Medical School
-
-
New York
-
New York、New York、アメリカ、10065
- Weill Cornell Medicine
-
New York、New York、アメリカ、10016
- NYU Langone
-
New York、New York、アメリカ、10029
- Mount Sinai New York
-
New York、New York、アメリカ、10032
- Columbia University Medical Center / NewYork-Presbyterian
-
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North Carolina
-
Chapel Hill、North Carolina、アメリカ、27599
- University of North Carolina
-
Charlotte、North Carolina、アメリカ、28277
- Sanger Heart and Vascular Institute
-
-
Ohio
-
Cleveland、Ohio、アメリカ、44195
- Cleveland Clinic
-
Cleveland、Ohio、アメリカ、44106
- Louis Stokes Cleveland VA Medical Center
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Columbus、Ohio、アメリカ、43210
- The Ohio State University Wexner Medical Center
-
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Oklahoma
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Tulsa、Oklahoma、アメリカ、74136
- St. Francis Tulsa
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Oregon
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Portland、Oregon、アメリカ、97239
- Portland VA Medical Center
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Pennsylvania
-
Bethlehem、Pennsylvania、アメリカ、18015
- St. Luke's Bethlehem
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Bryn Mawr、Pennsylvania、アメリカ、19010
- Bryn Mawr Medical Specialists Association
-
Lancaster、Pennsylvania、アメリカ、17602
- Lancaster General Hospital
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Philadelphia、Pennsylvania、アメリカ、19140
- Temple University
-
Philadelphia、Pennsylvania、アメリカ、19104
- Penn Presbyterian
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Pittsburgh、Pennsylvania、アメリカ、15212
- Allegheny General Hospital
-
Pittsburgh、Pennsylvania、アメリカ、15219
- University of Pittsburgh Medical Center
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South Carolina
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Greenville、South Carolina、アメリカ、29601
- Prisma Health
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Tennessee
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Germantown、Tennessee、アメリカ、38138
- Stern Cardiovascular Foundation
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Texas
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Austin、Texas、アメリカ、78705
- Texas Cardiac Arrhythmia Research Foundation
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Dallas、Texas、アメリカ、75230
- Medical City Dallas
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Dallas、Texas、アメリカ、75390
- UT Southwestern
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Fort Worth、Texas、アメリカ、76104
- Medical City Fort Worth
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Houston、Texas、アメリカ、77030
- Houston Methodist
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Houston、Texas、アメリカ、77030
- Houston VA Hospital
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Houston、Texas、アメリカ、77030
- UT Memorial Hermann
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Tyler、Texas、アメリカ、75702
- Christus Trinity Clinic
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Virginia
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Lynchburg、Virginia、アメリカ、24501
- Centra Health
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Richmond、Virginia、アメリカ、23298
- Virginia Commonwealth University
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Richmond、Virginia、アメリカ、23225
- Chippenham Hospital
-
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Washington
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Seattle、Washington、アメリカ、98122
- Swedish
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Seattle、Washington、アメリカ、98108
- Seattle VA
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参加基準
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:
Individuals must meet all the following:
- Patient is aged 18 years or older;
- Patient meets the Stage C or D criteria of the Universal Definition of Heart Failure ;
- Patient has HFrEF (LVEF ≤40%);
- Patient is on GDMT for heart failure;
- Patient has a Class I or Class II indication for an ICD
- Patient has a reasonable expectation of meaningful survival of > 1 year;
- Patient has either non-ischemic cardiomyopathy or ischemic cardiomyopathy and is at least 40 days post-MI, if an MI occurred;
- Patient is willing to give informed consent, available for scheduled study follow-up visits, and able to complete all testing described in the study protocol at the investigational site location.
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
- Patients should not have severe AI or AS, and should not have MS; additionally, patients undergoing DE testing should not have severe MR;
- Patients who have undergone mitral valve repair or clip within 90 days prior to study consent;
- Cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent;
- Prior heart transplant or ventricular assist device;
- Implanted mechanical tricuspid valve;
- PR interval greater than 375ms or advanced AV block;
- In situ S-ICD, pacemaker, or CRT device;
- Indicated for CRT;
- End stage renal disease, currently on dialysis, or with other major medical disorder (e.g. liver failure, terminal cancer);
- Indicated for permanent bradyarrhythmia pacing;
- Unstable angina pectoris within 30 days prior to study consent;
- Pregnant or planning to become pregnant during the study;
- Participating in another cardiac investigational device or drug study at the same time (or within 30 days prior to study consent); Note: Registries and other observational studies are acceptable.
- Other criteria that preclude Optimizer INTEGRA CCM-D implantation and/or CCM therapy, as determined by Investigator.
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）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：CCM-D Implant
The subject is implanted with the CCM-D device. |
The CCM-D System is an implantable cardiac device system that combines cardiac contractility modulation and implantable cardioverter defibrillator (ICD) modules into one device. CCM-D is also known as a "Cardiac Contractility Modulation - Defibrillator". All 300 subjects will be implanted with the CCM-D System and followed for a period of at least two years. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Device Effectiveness in Converting Induced Ventricular Fibrillation (Primary Efficacy Objective)
時間枠：Implant
|
Evaluate the device effectiveness in converting induced VF at the time of implantation. |
Implant
|
|
Device-related Complications (Primary Safety Objective)
時間枠：Implant to 6 months
|
Evaluate device-related complications through 6-months (excluding lead-related complications). |
Implant to 6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Inappropriate Shock Rate out to 6-months (Secondary Safety Objective)
時間枠：Implant to 6 months
|
Evaluate the incidence of inappropriate ICD shocks through the time when the last subject enrolled completes the 6-month visit. |
Implant to 6 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Inappropriate Shock Rate out to 2-years
時間枠：Implant to 2 years
|
Evaluate the device effectiveness in converting spontaneous VT/VF through the time when the last subject enrolled completes the 6-month visit. Each subject will be followed for 2-years after implant to capture additional spontaneous episodes that may occur. |
Implant to 2 years
|
|
Charging non-compliance
時間枠：Implant to 2 years
|
Evaluate subject charging non-compliance defined as >14 days between interval charging sessions, overall and frequency of non-compliance in the same subject. |
Implant to 2 years
|
|
Longitudinal levels of activity
時間枠：Implant to 2 years
|
Track longitudinal levels of activity weekly via OPTIhome (when available) and identification of trends. |
Implant to 2 years
|
|
Battery degradation and longevity
時間枠：Implant to 2 years
|
Assess battery degradation and longevity either remotely or during an in-person follow-up at 2 years (+/- 60 days) by recording QHR battery voltage as measured by the Integra CCM-D IPG. The measurement under nominal conditions is expected to be 2.85V or higher, consistent with a 20-year device longevity. |
Implant to 2 years
|
|
Compare worsening heart failure events pre- and post-implant
時間枠：12 months prior to implant and 12 months post-implant
|
Track unscheduled cardiovascular-related healthcare encounters from 12 months prior to implant, if available, to 12 months post-implant |
12 months prior to implant and 12 months post-implant
|
|
All-cause mortality
時間枠：1 and 2 years post-implant
|
Assess all-cause mortality using Seattle Heart Failure Model (SHFM) and comorbidity burden as a predictive comparator at 1 year and 2 years post-implant |
1 and 2 years post-implant
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
時間枠：Baseline to 6-months
|
Compare change in subject's perception of their heart failure symptoms, as measured by KCCQ, from baseline to 6 months. |
Baseline to 6-months
|
|
EQ-5D-5L
時間枠：Baseline to 6-months
|
Compare change in subject's perception of their health status, as measured by the EQ-5D-5L, from baseline to 6 months. |
Baseline to 6-months
|
|
Six Minute Walk Distance (6MWD)
時間枠：Baseline to 6 months
|
Compare change in functional capacity, as measured by 6MWD, from baseline to 6 months. |
Baseline to 6 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Nir Uriel, MD、Columbia University
- 主任研究者：Niraj Varma, MD, PhD、The Cleveland Clinic
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
詳しくは
本研究に関する用語
その他の研究ID番号
- RG_PRO_345
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?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。