Cardiac Autonomic Nerve Improvement and Pacemaker Therapy in Patients With Sinus Bradycardia
A Multicenter Randomized Controlled Study of Cardiac Autonomic Nerve Improvement and Pacemaker Therapy in Patients With Sinus Bradycardia
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Xu Liu, MD
- 電話番号:+8613052320103
- メール:heartlx@sina.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
説明
Inclusion Criteria:
- Aged 18 to 80 years old;
- Symptomatic sinus bradycardia;
- Not meet the class I indications for pacemaker implantation.
Exclusion Criteria:
- Structural heart disease, heart surgery history;
- Drug-induced SB, sinus pause >2.0 s, positive atropine test, corrected sinus node recovery time (cSNRT) >525 ms;
- Any atrial or ventricular arrhythmia, or a history of ablation procedures to treat atrial tachyarrhythmias;
- With Significant congenital heart disease, ejection fraction was <40% measured by echocardiography;
- Allergic to contrast media;
- Contraindication to anticoagulation medications;
- Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);
9. Poor general health; 10.Life expectancy less than 6 months.
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:ランダム化
- 介入モデル:並列代入
- 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 |
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実験的:Cardiac autonomic nerve modification
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Patients with sinus bradycardia undergoing cardiac autonomic ganglion ablation.
Specific anatomic ablation of the 4 major left atrial GP and aorta-superior vena cava (Ao-SVC) GP was performed.
Briefly, catheter ablation was performed under the guidance of an electroanatomic mapping system (CARTO,BiosenseWebster,DiamondBar,California).
After completed the electroanatomic mapping of the left atrium was complete and pulmonary vein (PV) ostia identified, presumed GP clusters were ablated 1 to 2cm outside the PV-left atrium junctions at the following sites: the left superolateral area (leftsuperior GP[LSGP]), the leftinfer oposterior area(left inferior GP[LIGP]), the right superoanterior area (rightanterior GP[RAGP]), the right inferoposterior area(right inferior GP[RIGP]), and the Ao-SVC fat pad (Ao-SVCGP), and in that sequence.
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アクティブコンパレータ:Pacemaker
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Patients with sinus bradycardia received pacemaker implantation.
The patient lay flat on the bed, puncture the subclavian vein and insert two guide wires.
Cut the skin under the guide wire to make a skin bag, and stop bleeding accurately to avoid continuous bleeding of the skin bag.
The pacemaker electrode is inserted into the heart cavity by guiding the guide wire, one is placed in the ventricle and the other in the atrium, and the corresponding parameters of the electrode, such as pacing threshold, impedance, etc., are measured at the same time.
If the parameters are good, fix the electrode, connect the electrode with the pacemaker, place the pacemaker in the skin bag, fix the pacemaker and electrode, suture the skin layer by layer, and the operation is completed.
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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 |
|---|---|---|
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Symptom score after operation
時間枠:48 months
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Each patient subjectively assessed his or her SB-related symptom, including dizziness, fatigue, and palpitation, on a score of 1 to 10 points (mildtosevere).
The total SB-related symptom score for each patient was calculated as the sum of all scores for individual symptoms.
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48 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Quality of life score
時間枠:48 months
|
The Medical Outcomes Study Short-Form 36 Health Survey (SF-36) was used to assess quality of life (QoL) at baseline and 12 months after ablation.
The self-administration mode was strictly followed for QoL surveys.
TheSF-36 assesses 8 specific QoL domains, namely physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problem, and mental health.
For each subscale, scores were transformed to a scale ranging from 0 to 100, with lower scores representing a lower QoL.
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48 months
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Psychological quality score
時間枠:48 months
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The Zung Self-Rating Depression Scale is a short self administered survey to quantify the depressed status of a patient. There are 20 items on the scale that rate the four common characteristics of depression: the pervasive effect, the physiological equivalents, other disturbances, and psychomotor activities. There are ten positively worded and ten negatively worded questions. Each question is scored on a scale of 1-4 (a little of the time, some of the time, good part of the time, most of the time). |
48 months
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
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
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