Dual Energy Focal Ablation of Premature Ventricular Complexes (DUAL-PVC)
Dual Energy (RF/PF) Focal Ablation of Premature Ventricular Complexes: the DUAL-PVC Prospective Clinical Trial
The purpose of this research is to understand whether a dual-energy catheter ablation system that uses radiofrequency (RF) and pulsed-field (PF) energy can safely and effectively treat premature ventricular contractions (PVCs).
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
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
研究連絡先
研究連絡先
- 名前：Konstantinos Siontis, MD
- 電話番号：507-255-0774
- メール：siontis.konstantinos@mayo.edu
研究場所
-
-
Minnesota
-
Rochester、Minnesota、アメリカ、55905
- Mayo Clinic
-
-
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:
-
≥10% burden of the target PVC on ambulatory rhythm monitoring within 3 months prior to enrollment. The qualifying ambulatory monitor may be of any duration (1-30 days) per standard of care and may be distinct from the baseline 12-lead Holter required within 30 days before ablation
-
Guideline-supported indication for first-time or redo catheter ablation of PVCs at the judgment of the electrophysiologist. Specifically:
- Patients with symptomatic PVCs for whom antiarrhythmic medications are ineffective, not tolerated, or not the patient's preference.
- Suspected or confirmed PVC-induced cardiomyopathy
- Enrollment of patients requiring a redo procedure will be capped at 30% of planned enrollment (n=18) if the target PVC is the same or similar to that targeted in previous procedure(s), per review of the study investigator
-
Patients with and without known structural heart disease are eligible
-
Ability to undergo study-directed cardiac MRI pre- and post-procedure
-
Ability to undergo study-directed post-ablation coronary CT angiography
-
Ability to provide written informed consent
Exclusion Criteria:
- LVEF <35%
- NYHA class IV
- Presence of multifocal PVCs (>=3 distinct morphologies) on available pre-baseline standard-of-care ambulatory monitor and ECG tracings per the review of the study team.
- PVCs attributable to a reversible or non-cardiac cause (e.g., electrolyte imbalance or active thyroid disease).
- History of sustained VT or VF.
- Current or recent (<4 weeks) decompensated heart failure.
- Active systemic infection.
- Contraindication to LGE-MRI or contrast CT.
- Known allergy to iodinated contrast dye that cannot be adequately managed with pre-medication protocol.
- Thrombocytopenia (platelet count <50,000/mm³) or known coagulopathy.
- Contraindication to systemic anticoagulation.
- Severe valvular disease requiring future intervention.
- Mechanical valve prosthesis.
- Pregnancy.
- Recent acute coronary syndrome (<6 months).
- Un-revascularized coronary artery disease.
- Presence of left ventricular assist device (LVAD) or transplanted heart.
- Presence of intracardiac thrombus.
- Current use of inotropes.
- Recent stroke or TIA (<6 months).
- Presence of a systemic illness likely to limit survival to <1 year.
- Patient enrollment in other clinical study that could conflict with the current investigation.
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）
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 |
|---|---|
|
実験的：RF-PF Sequential Ablation
Participants are assigned to receive radiofrequency (RF) followed by pulsed-field (PF) at each selected treatment site. For each PF treatment, 24 PF bursts are delivered. Up to three stacked lesions may be performed at the same location. |
The THERMOCOOL SMARTTOUCH™ SF Bi-Directional Navigation Catheter is an irrigated, contact-force-sensing catheter used to map the heart and deliver radiofrequency (RF) or pulsed-field (PF) energy to selected treatment sites. The catheter is connected to the TRUPULSE™ Generator, which provides both energy types, and to the nGEN™ Pump, which controls saline irrigation. The system is used with the CARTO™ 3 electroanatomic mapping system and workstation with the VISITAG SURPOINT™ Module to display heart anatomy, catheter location, catheter-to-tissue contact, and treatment information during the procedure. |
|
実験的：PF-Only Ablation
Participants are assigned to receive pulsed-field (PF) alone at each selected treatment site. For each PF treatment, 24 PF bursts are delivered. Up to three stacked lesions may be performed at the same location. |
The THERMOCOOL SMARTTOUCH™ SF Bi-Directional Navigation Catheter is an irrigated, contact-force-sensing catheter used to map the heart and deliver radiofrequency (RF) or pulsed-field (PF) energy to selected treatment sites. The catheter is connected to the TRUPULSE™ Generator, which provides both energy types, and to the nGEN™ Pump, which controls saline irrigation. The system is used with the CARTO™ 3 electroanatomic mapping system and workstation with the VISITAG SURPOINT™ Module to display heart anatomy, catheter location, catheter-to-tissue contact, and treatment information during the procedure. |
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 |
|---|---|---|
|
Number of Participants With Successful Delivery of Ablation Lesions Using the Dual-Energy THERMOCOOL SMARTTOUCH SF Catheter With the TRUPULSE Generator
時間枠：During the index ablation procedure
|
Feasibility is defined as successful delivery of ablation energy at the targeted premature ventricular complex (PVC) site. Delivery counts as successful only if there is no study device deficiency or malfunction that prevents energy delivery, and no need to convert to a bailout ablation approach. |
During the index ablation procedure
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Acute procedural success
時間枠：End of the ablation procedure
|
Number of participants with elimination of the target premature ventricular contraction by the end of the procedure. |
End of the ablation procedure
|
|
Participants with greater than 80% reduction in target PVC burden
時間枠：1 month, 6 months
|
Number of participants with greater than 80% reduction from baseline in the burden of the target premature ventricular contraction on Holter monitoring. |
1 month, 6 months
|
|
Change in Short Form Health Survey (SF-36) score
時間枠：Baseline, 1 month, 6 months
|
The 36-Item Short Form Health Survey (SF-36) is a participant-reported questionnaire that assesses health-related quality of life across eight domains: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Total scores range from 0 to 100. Higher scores indicate better health status. |
Baseline, 1 month, 6 months
|
|
Change in EQ-5D score
時間枠：Baseline, 1 month, 6 months
|
The EQ-5D is a participant-reported measure of health-related quality of life covering five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses across the five dimensions define the participant's health state. Higher scores indicate better health. |
Baseline, 1 month, 6 months
|
|
Number of Participants With New Coronary Artery Stenosis on Coronary CT Angiography at 6 Months After Ablation
時間枠：6 months
|
Total number of patients with new-onset coronary luminal stenosis found on CT coronary angiography |
6 months
|
|
Total Procedure Time
時間枠：From start to finish of index ablation procedure
|
Total procedure time will be reported in minutes |
From start to finish of index ablation procedure
|
|
Electrogram endpoints
時間枠：Intraprocedure
|
EGM amplitude changes after PF, RF, and RF-PF lesion delivery |
Intraprocedure
|
|
Ablation Lesion Depth
時間枠：1 month and 6 months after ablation
|
Maximum depth of the ablation lesion at the target premature ventricular complex (PVC) site. Depth is measured from the endocardial surface on late gadolinium enhancement (LGE) cardiac MRI. Only participants with an evaluable post-ablation MRI are analyzed. Reported in millimeters. |
1 month and 6 months after ablation
|
|
Ablation Lesion Width
時間枠：1 month and 6 months after ablation
|
Maximum width of the ablation lesion at the target PVC site, measured on LGE cardiac MRI. Only participants with an evaluable post-ablation MRI are analyzed. Reported in millimeters. |
1 month and 6 months after ablation
|
|
Ablation Lesion Volume
時間枠：1 month and 6 months after ablation
|
Total volume of the ablation lesion at the target PVC site, measured on LGE cardiac MRI. Only participants with an evaluable post-ablation MRI are analyzed. Reported in cubic centimeters. |
1 month and 6 months after ablation
|
|
Number of Radiofrequency (RF) Lesions Delivered per Participant
時間枠：During the index ablation procedure
|
Total number of RF lesions delivered with the study catheter during the index procedure |
During the index ablation procedure
|
|
Number of Pulsed-Field (PF) Lesions Delivered per Participant
時間枠：During the index ablation procedure
|
Total number of PF lesions delivered with the study catheter during the index procedure |
During the index ablation procedure
|
協力者と研究者
捜査官
捜査官
- 主任研究者：Konstantinos Siontis, MD、Mayo Clinic
研究記録日
主要日程の研究
研究開始 (推定)
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
その他の研究ID番号
その他の研究ID番号
- 25-013930
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。