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This prospective, multicenter, open-label, randomized-controlled trial compares two treatment strategies in high-risk ischemic cardiomyopathy (ICM) patients referred for primary ICD implantation. Participants will be randomized to receive either prophylactic VT ablation within three months of ICD implantation or continued medical management. The primary objective is to assess the efficacy of preventive VT ablation versus medical management in reducing VT arrhythmia burden.
This study aims to assess the impact of prophylactic catheter-based ventricular tachycardia (VT) ablation compared to medical management in high-risk patients with ischemic cardiomyopathy (ICM) undergoing primary implantable cardioverter defibrillator (ICD) implantation. The primary outcome measure is the burden of VT arrhythmias (VTA), defined as the total number of VT events, one year post-ICD implantation. The hypothesis suggests that employing VT ablation with high-density electroanatomic mapping (EnsiteTM) will significantly reduce both treated and monitored VT episodes. The study will randomize 62 participants in a 1:1 ratio across 20 experienced sites in Europe.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prophylactic Catheter-based VT Ablation | Experimental | Subjects receive catheter-based ventricular tachycardia (VT) ablation within 3 months of primary ICD implantation. |
|
| Continued Medical Management | No Intervention | Subjects undergo continued medical management after primary ICD implantation without prophylactic VT ablation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prophylactic Catheter-based VT Ablation | Procedure | Prophylactic Catheter-based VT Ablation refers to a treatment strategy where participants undergo a procedure known as catheter-based ventricular tachycardia (VT) ablation shortly after receiving their primary implantable cardioverter defibrillator (ICD). |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of VT Arrhythmia Events in High-Risk Patients with Ischemic Cardiomyopathy (ICM) After Primary ICD Implantation: Comparison of Preventive Catheter-Based VT Ablation Versus Medical Management. | Evaluating the impact of preventive catheter-based VT ablation versus medical management on the total number of VT arrhythmia events in high-risk patients with ischemic cardiomyopathy (ICM) after primary ICD implantation. | One year following ICD implantation. |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of Preventive VT Ablation on Healthcare Utilization, assessed using the mean rate of events per arm. | Assessing whether preventive VT ablation compared to medical management reduces healthcare resource utilization in high-risk patients with ICM after primary ICD implantation. Healthcare resource utilization will be quantified by averaging planned and unplanned in-office visits, urgent care or emergency room visits, hospitalizations, repeat ablations, or mortality per arm. Data on healthcare utilization will be collected at all follow-up visits (months 3, 6, and 9) and at the end-of-study visit. Analysis will be conducted using a t-test for comparison. |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of Preventive VT Ablation on the Quality of Life Using the Kansas City Cardiomyopathy Questionnaire (KCCQ). | Assessing whether preventive VT ablation compared to medical management enhances quality of life in high-risk patients with ICM after primary ICD implantation, using the Kansas City Cardiomyopathy Questionnaire (KCCQ) to measure quality of life. Scores on the KCCQ range from 0 to 100, with higher scores indicating better quality of life. Data collection with the KCCQ will occur at the Baseline and End of Study visits. Differences in quality of life between the study groups will be analyzed using the t-test based on KCCQ responses. |
Inclusion Criteria:
One or more of the following:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ilan Goldenberg, MD | Contact | 585-275-5391 | Ilan_Goldenberg@URMC.Rochester.edu | |
| Misty Ra-Amari, BA | Contact | Misty_RaAmari@URMC.Rochester.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Righospitalet | Recruiting | Copenhagen | Region H | 2800 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31102616 | Background | Cronin EM, Bogun FM, Maury P, Peichl P, Chen M, Namboodiri N, Aguinaga L, Leite LR, Al-Khatib SM, Anter E, Berruezo A, Callans DJ, Chung MK, Cuculich P, d'Avila A, Deal BJ, Della Bella P, Deneke T, Dickfeld TM, Hadid C, Haqqani HM, Kay GN, Latchamsetty R, Marchlinski F, Miller JM, Nogami A, Patel AR, Pathak RK, Saenz Morales LC, Santangeli P, Sapp JL Jr, Sarkozy A, Soejima K, Stevenson WG, Tedrow UB, Tzou WS, Varma N, Zeppenfeld K. 2019 HRS/EHRA/APHRS/LAHRS expert consensus statement on catheter ablation of ventricular arrhythmias: Executive summary. Heart Rhythm. 2020 Jan;17(1):e155-e205. doi: 10.1016/j.hrthm.2019.03.014. Epub 2019 May 10. | |
| 15583079 |
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Subjects will be randomized in a 1:1 fashion to undergo either prophylactic catheter-based ventricular tachycardia (VT) ablation within 3 months of primary ICD implantation or continued medical management after ICD implantation.
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|
| One year following ICD implantation. |
| One year following ICD implantation. |
| Centre Hospitalier De Pau | Recruiting | Pau | Gave de Pau | 64000 | France |
|
| Hopital Trousseau Chru de Tours | Recruiting | Chambray-lès-Tours | Indre-et-Loire | 37170 | France |
|
| Centre Hospitalier Universitaire de Bordeaux | Recruiting | Pessac | France |
|
| Unidad de Arritimias, Hospital ClÃnic Barcelona | Recruiting | Barcelona | Spain |
|
| Background |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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