Primary Preventive Ventricular Tachycardia Ablation In High-Risk Patients Who Receive A Prophylactic Implantable Cardioverter Defibrillator
Recruiting · NCT06543173 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Rochester
View the official record on ClinicalTrials.gov →Interventions studied
Prophylactic Catheter-based VT Ablation
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age ≥ 18 years (no upper age limit)
- Willing and able to provide informed consent
- Candidate for a primary prevention ICD/CRT-D per ESC guidelines17
- Ischemic cardiomyopathy (ICM) with left ventricular ejection fraction (LVEF) ≤ 35%
- Willing and able to receive an ICD
- Willing and able to undergo catheter-based VT ablation
- ne or more of the following:
- MADIT-ICD Benefit Score \>75
- History of nonsustained ventricular tachycardia (NSVT)
- Multiple premature ventricular complexes (PVCs ≥10%)
Exclusion criteria
- Existing ICD or CRT-D
- History of sustained VT or VF
- Chronic renal failure requiring hemodialysis
- Coronary revascularization within the past 3 months
- ST-Elevation MI within the past 3 months
- Participation in concurrent clinical trials without approval from the Coordination Center (observational registries are allowed with approval)
- Currently pregnant or planning to become pregnant in the near future
- Inability or unwillingness to adhere to the study protocol
- Inability or unwillingness to provide informed consent for participation
- Life expectancy \< 1 year
Where it is running
5 locations listed.
- Unidad de Arritimias, Hospital Clínic Barcelona - Barcelona, Spain
- Centre Hospitalier Universitaire de Bordeaux - Pessac, France
- Centre Hospitalier De Pau - Pau, Gave de Pau, France
- Hopital Trousseau Chru de Tours - Chambray-lès-Tours, Indre-et-Loire, France
- Righospitalet - Copenhagen, Region H, Denmark