The CLASP III TR CED Study
Edwards PASCAL Transcatheter Tricuspid Valve Repair System Coverage With Evidence Development Study (The CLASP III TR CED Study)
This Coverage with Evidence Development (CED) study measures the long-term health outcomes of patients with severe, symptomatic Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Repair procedure using the PASCAL Precision system.
調査の概要
状態
詳細な説明
This is a prospectively designed, retrospective non-randomized cohort study to measure the 2-year effectiveness of the PASCAL Precision Transcatheter Valve Repair system ("PASCAL Precision system") for the treatment of at least severe tricuspid regurgitation in the real world.
This study will evaluate patients treated with the PASCAL Precision system who have at least severe Tricuspid Regurgitation as compared to Medicare eligible untreated patients. Analysis will be completed using a large, de-identified, claims and electronic health record (EHR) database and supplemented with registry and other claims data.
The primary outcome will also be assessed in various pre-defined subgroups.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：TMTT GHER
- 電話番号：949-250-2500
- メール：TMTT_GHER_Evidence@edwards.com
研究場所
-
-
California
-
Irvine、California、アメリカ、92614
- Edwards Lifesciences
-
コンタクト：
- TMTT GHER
- 電話番号：949-250-2500
- メール：TMTT_GHER_EVIDENCE@edwards.com
-
-
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
サンプリング方法
調査対象母集団
Medicare eligible real-world patients with severe tricuspid regurgitation
説明
Inclusion Criteria:
- Medicare eligible patients, 65 years old or older
- With at least severe Tricuspid Regurgitation who have either received PASCAL Precision system or been managed medically with no transcatheter or surgical tricuspid valve intervention
Exclusion Criteria:
- Patients not eligible for Medicare (i.e., under 65 years old)
- Patients with less than severe Tricuspid Regurgitation
- Patients who have received a transcatheter or surgical intervention other than PASCAL Precision system
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
- 観測モデル：COHORT
- 時間の展望：RETROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
PASCAL Precision system Treated
Patients 65 years old or older with at least severe Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Repair with the PASCAL Precision system. |
Patients 65 years old or older with at least severe Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Repair with the PASCAL Precision system. |
|
Medicare Eligible Untreated Patients
Patients 65 years old or older with at least severe Tricuspid Regurgitation who did not receive any transcatheter or surgical tricuspid valve intervention. |
Patients 65 years old or older with at least severe Tricuspid Regurgitation who did not receive any transcatheter or surgical tricuspid valve intervention. |
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 |
|---|---|---|
|
Composite (All-Cause Death or Heart Failure Hospitalization)
時間枠：2 years
|
Time to death or heart failure hospitalization after time zero |
2 years
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
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
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。