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New treatment option for Heart Failure
Official title Primary Preventive Ventricular Tachycardia Ablation In High-Risk Patients Who Receive A Prophylactic Implantable Cardioverter Defibrillator
ClinicalTrials.gov ID: NCT06543173
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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 One or more of the following:
- MADIT-ICD Benefit Score \>75
- History of nonsustained ventricular tachycardia (NSVT)
- Multiple premature ventricular complexes (PVCs ≥10%)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Region H, Denmark
- Pau, Gave de Pau, France
- Chambray-lès-Tours, Indre-et-Loire, France
- Pessac, France
- Barcelona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Region H, Denmark; Pau, Gave de Pau, France; Chambray-lès-Tours, Indre-et-Loire, France; Pessac, France; Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.