The 4-SITE Field Following Study (4-SITE FF) (4-SITE FF)
RELIANCE QUADRIPOLAR DEFIBRILLATION LEADS (4-SITE)FIELD FOLLOWING The 4-SITE Field Following Study (4-SITE FF)
The purpose of this study is to evaluate and document appropriate clinical performance of the new 4-SITE Header / Lead interface in the TELIGEN 100 HE 4-SITE (VR and DR) implantable cardioverter defibrillator (ICD) PGs (Models F103; F111), the COGNIS 100 HE 4-SITE cardiac resynchronization therapy ICD (CRT-D) PG (Model P108) when connected to any of the RELIANCE Quadripolar (4-SITE) defibrillation leads.
Appropriate clinical performance of system components of the 4-SITE systems other than the new 4-SITE header / lead interface has been evaluated and documented already in the previously conducted COGNIS and TELIGEN 100 HE FIELD FOLLOWING STUDY, The COGENT-4 Field Following Study.
Data collected may be used to support international regulatory submissions including the FDA and the Japanese Ministry of Health, Labour and Welfare.
調査の概要
状態
詳細な説明
The following devices will be used (all are CE-marked):
TELIGEN 100 HE 4-SITE (Single and Dual Chamber ICD)
- Model Number: F103 (Quadripolar, VR);
- Model Number: F111 (Quadripolar, IS-1, DR)
COGNIS 100 HE 4-SITE (CRT-D)
o Model Number: P108 (Quadripolar, IS-1, IS-1)
- RELIANCE 4-SITE leads (12 different model numbers in total as shown in the table below)
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Nordrhein-Westfalen
-
Bad Oeynhausen、Nordrhein-Westfalen、ドイツ、D - 32545
- Bad Oeynhausen Herz- und Diabeteszentrum Nordrhein-Westfalen
-
-
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
説明
Inclusion Criteria:
Study Specific:
- ICD / CRT-D Indication according to normal clinical practice
- Patients receiving:
- a single or dual chamber 4-SITE compatible ICD
- or a 4-SITE compatible CRT-D
- one of the RELIANCE 4-SITE defibrillation leads
- Patients currently implanted with a pacemaker
- upgraded to a 4-SITE compatible ICD or CRT-D (4-SITE header)
- one of the RELIANCE 4-SITE defibrillation leads
General:
- Willing and capable of providing informed consent for
- undergoing a 4-SITE system implant,
- participating in all testing associated with this clinical investigation at an approved clinical investigational centre and at the intervals defined by this protocol
- Geographically stable patients who are available for follow-up at a study centre
- Age 18 or above, or of legal age to give informed consent specific to national law
Exclusion Criteria:
Study Specific:
- ICD and CRT-D Patients scheduled for a device replacement
- CRM Patients who have or who would need an lead adaptor
- All patients who have an active or non-active defibrillation lead other than 4-SITE
General:
- Not willing and not capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation (including VT/VF shock conversion) at an approved clinical investigational centre and at the intervals defined by this protocol
- Patients who were in NYHA Class IV during the last 3 month
- Patients with pre-existing diseases, which may confound study results
- Patients currently requiring dialysis,
- Cancer patients
- Patients with drug and/or alcohol abuse history
- Life expectancy < 12 months (or expected heart transplant within 12 months)
- Patients on a Heart Transplant List
- Women who are pregnant or plan to become pregnant. Method of assessment per physician discretion.
- Enrolled in any other concurrent study
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
- 時間の展望：見込みのある
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 |
|---|---|---|
|
Appropriate Detection of induced VT
時間枠：At Implant or during VT/VF testing up to one month after implant
|
Induced mean VT/VF detection time < 4.5 seconds
|
At Implant or during VT/VF testing up to one month after implant
|
|
Appropriate induced VT/VF Shock Conversion
時間枠：At Implant or during testing within one month after implant
|
Successful VT/VF conversions (with 41 J, no external shock) will be 93% or higher
|
At Implant or during testing within one month after implant
|
|
Appropriate pacing thresholds at follow-up with the 4-SITE defibrillation leads
時間枠：entire duration of the study
|
Mean pacing threshold post implant ≤ 1.5V
|
entire duration of the study
|
|
Appropriate Lead Impedances as a measure of lead integrity over 12 month time
時間枠：entire study duration
|
|
entire study duration
|
|
Appropriate sensing and absence of artefacts
時間枠：entire duration of study
|
Appropriate sensing and absence of artefacts during standardized pocket manipulations and standardized provocative maneuvers during FU
|
entire duration of study
|
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
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
キーワード
その他の研究ID番号
- 4-SITE FF 0209
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。
ICD and CRT-D Indicated Patientsの臨床試験
-
Abbott Medical Devices完了患者は植込み型除細動器 (ICD) または心臓再同期療法 (CRT-D) 装置に関する ACC/AHA/ESC ガイドラインを満たしていますイギリス, ドイツ