Ventricular TachycardiaEXACT-VTNCT07706712
Evaluation of the DuoVT PFA System for Ventricular Tachycardia
A study testing Ablation procedure with DuoVT PFA system in people with Ventricular Tachycardia, run by Abbott Medical Devices at 5 sites in 4 countries.
Trial summary
This study is a prospective, non-randomized, single-arm, multicenter study to evaluate the safety and effectiveness of the DuoVT Pulsed Field Ablation (PFA) System. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- Ablation procedure with DuoVT PFA system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 29 Sep 2026to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sustained Monomorphic Ventricular Tachycardia (SMMVT) with Ischemic Cardiomyopathy (ICM)
- Patients with SMMVT and ischemic cardiomyopathy meet all of the following criteria:
- History of myocardial infarction (MI)
- At least one episode of sustained (continuous for >30 seconds or requiring ICD intervention for termination) monomorphic ventricular tachycardia within the 180 days prior to enrollment
- SMMVT recurrence despite class I or III antiarrhythmic drug therapy, or when AAD therapy is not tolerated, contraindicated or not desired
- Implanted with an ICD (transvenous or subcutaneous) or CRT-D prior to the index ablation; for transvenous systems, leads must be implanted ≥30 days prior.
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- Frequent premature ventricular complexes (PVCs) meeting class II a/b indications for ablation with documentation of PVCs on 24-Hour monitor in the 90 days prior to enrollment. Subjects should meet one or more of the following criteria:
- Symptomatic PVCs when class I or III AADs have failed, are not tolerated, or are not desired (class II a)
- Suspected PVC-induced cardiomyopathy (>10% burden) (class II a)
- Frequent PVCs in patients with structural heart disease (>10% burden) (class II a)
- Asymptomatic, high burden PVCs (>15% burden) (class II b)
- 2. Age 18 through 80 years old 3. Willing and able to provide written informed consent 4. Willing and able to comply with the study visit schedule and requirements
Who cannot join
- General Exclusion Criteria:
- Cardiac Conditions
- Unstable angina within the prior 60 days.
- Active myocardial ischemia.
- Myocardial infarction within 60 days prior to the ablation procedure.
- Any percutaneous coronary intervention within 60 days prior to the ablation procedure.
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- Any cardiac surgery within 90 days prior to the ablation procedure.
- Left ventricular ejection fraction (LVEF) < 15%.
- NYHA Class IV heart failure.
- Decompensated heart failure at the time of enrollment.
- Currently receiving support or anticipated to receive support prior to the index ablation procedure, via extracorporeal membrane oxygenation (ECMO).
- Ventricular assist device (VAD) implanted, planned, or required for the procedure.
- The Micra™ Leadless Cardiac Implantable Electronic Device (CIED) or CIEDs with a left ventricular endocardial lead
- Severe aortic or mitral stenosis, or severe aortic or mitral regurgitation.
- Tricuspid or mitral valve replacement or repair (inclusive of Mitral/Tricuspid clips) or prosthetic valve procedure
- Prohibitively distorted cardiac anatomy due to congenital heart disease.
- Vascular and Thromboembolic Conditions
- Presence of intracardiac thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation.
- Thromboembolic event (stroke or transient ischemic attack) within 90 days prior to the index ablation procedure.
- Left atrium (LA) or left ventricle (LV) intracardiac thrombus on imaging.
- Severe bleeding, clotting or thrombotic disorder, or thrombocytopenia (defined as platelet count < 80,000).
- Contraindication to anticoagulation.
- Pulmonary and Renal
- Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspnea.
- Chronic renal insufficiency of eGFR < 30 mL/min/1.73 m².
- Systemic and General Medical Conditions
- Active infection or sepsis.
- Life expectancy less than 12 months.
- Body mass index > 40 kg/m².
- Currently being evaluated for an organ transplant.
- Pregnancy or breastfeeding.
- Study-Related Exclusions
- Participation in another investigational study or treatment with any investigational drug within the previous 30 days that would interfere with this study. Each instance must be brought to the attention of the Sponsor to determine eligibility.
- Patient is not able to understand the nature of this study or is unwilling or unable to attend the study procedures.
- Serious or untreated medical conditions that would prevent participation in the study, interfere with assessment or therapy, or confound data or its interpretation.
- Any of the following:
- Any ablation procedure for VT or PVC within the previous 90 days of enrollment, or
- More than 1 ablation procedure for VT or PVC within the previous 365 days of enrollment
- SMMVT only exclusions:
- Non-ischemic cardiomyopathy (NICM)
- Hypertrophic cardiomyopathy, except when due to an apical aneurysm
- Incessant VT necessitating hemodynamic support prior to the ablation procedure
- Unstable polymorphic VT or ventricular fibrillation (VF)
- VTs due to any of the following:
- Automaticity or triggered activity
- Lamin or titin genetic mutation
- VT secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause (e.g., drug-induced arrhythmia)
- VT or VF thought to be from channelopathies
Trial locations and contacts
5 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Christine Sasaridis contact
5 sites in 4 countries
Italy2 sites, 2 recruiting
- Not yet recruiting
Casa di Cura Montevergine
Mercogliano, Campani, 83013
Francesco Solimene
- Not yet recruiting
Ospedale San Raffaele
Milan, Lombard, 20132
Paolo Della Bella
Croatia1 site, 1 recruiting
- Recruiting
University Hospital of Split
Split, Dalmtia, 21000
Ante Anic
Czechia1 site, 1 recruiting
- Not yet recruiting
IKEM Prague
Prague, Cbohmia, 14021
Petr Peichl
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, Madrid, 28034
Javier Moreno Planas
About this study
This study is a prospective, non-randomized, single-arm, multicenter study to evaluate the safety and effectiveness of the DuoVT Pulsed Field Ablation (PFA) System.
- Conditions
- Ventricular Tachycardia
- Being tested
- Ablation procedure with DuoVT PFA system
- Keywords
- SMMVT, MMVT, PVC, PFA, arrhythmia, Pulse Field Ablation, Ablation Catheter
- Medical subject headings
- Tachycardia, Ventricular, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablation procedure with DuoVT PFA systemDevice
cardiac ablation procedures with PFA and radiofrequency therapy settings (DuoVT PFA system )
| Study group | Role | What they receive |
|---|---|---|
| frequent premature ventricular complexes & sustained monomorphic ventricular tachycardia group | Experimental | Ablation procedure of sustained monomorphic ventricular tachycardia (SMMVT) or frequent premature ventricular complexes (PVCs) Receives: Device: Ablation procedure with DuoVT PFA system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects Experiencing a Device- and/or Procedure-Related Primary Safety Adverse Event Within 7 Days
the proportion of subjects experiencing one or more predefined Primary Safety Adverse Events (PSAEs) that are determined to be definitely related to the device and/or procedure, with onset within 7 days of the index ablation procedure
Measured: 7 days
Non-inducibility of Targeted Clinical SMMVT Following Index Ablation Procedure (< 200 BPM)
Non-inducibility of the targeted clinical sustain monomorphic ventricular tachycardia (SMMVT) at the end of the index ablation procedure. Non-inducibility of targeted clinical SMMVT(s) slower than 200 bpm (CL 300 ms)
Measured: at the end of the procedure
Elimination of Targeted Clinical PVC Following Index Ablation Procedure (reassessment for spontaneous PVCs and repeat pacing post ablation).
Elimination of targeted clinical premature ventricular complex (PVC) at the end of the index ablation procedure following a 20-minute wait period. Post-ablation testing should be performed to confirm effectiveness and should include reassessment for spontaneous PVCs and repeat pacing if it was used initially.
Measured: at the end of the procedure following a 20-minute wait period
Secondary outcomes (2)
Freedom from Recurrent SMMVT Without Antiarrhythmic Drug Escalation Through 6 Months
proportion of subjects free from recurrent SMMVT in the absence of a new or increased dose of a class I or class III antiarrhythmic drug (AAD) for VT management, starting at day 15 following the index ablation procedure continuing through 6 months of follow-up.
Measured: 6Months visit
Achievement of PVC Burden <2% as Assessed by 24-Hour Holter Monitoring at 6 Months
proportion of subjects achieving a PVC burden of <2% as assessed by 24-hour Holter monitoring at 6 months post-procedure
Measured: 6Months visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start29 Sep 2026
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706712
- Sponsor's protocol ID
- ABT-CIP-10645
- Acronym
- EXACT-VT
- Status last verified
- Oct 2026
- First submitted
- 7 Jul 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the DuoVT PFA System for Ventricular Tachycardia
- ClinicalTrials.gov ID
- NCT07706712
- Acronym / sponsor ID
- EXACT-VT / ABT-CIP-10645
- Conditions
- Ventricular Tachycardia
- Keywords
- SMMVT, MMVT, PVC, PFA, arrhythmia, Pulse Field Ablation, Ablation Catheter
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2026 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, non-randomized, single-arm, multicenter study to evaluate the safety and effectiveness of the DuoVT Pulsed Field Ablation (PFA) System.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| frequent premature ventricular complexes & sustained monomorphic ventricular tachycardia group | Experimental | Device: Ablation procedure with DuoVT PFA systemAblation procedure of sustained monomorphic ventricular tachycardia (SMMVT) or frequent premature ventricular complexes (PVCs) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Sustained Monomorphic Ventricular Tachycardia (SMMVT) with Ischemic Cardiomyopathy (ICM)
- Frequent premature ventricular complexes (PVCs) meeting class II a/b indications for ablation with documentation of PVCs on 24-Hour monitor in the 90 days prior to enrollment. Subjects should meet one or more of the following criteria:
- 2. Age 18 through 80 years old 3. Willing and able to provide written informed consent 4. Willing and able to comply with the study visit schedule and requirements
Key exclusion criteria (48 listed)
- Cardiac Conditions
- Unstable angina within the prior 60 days.
- Active myocardial ischemia.
- Myocardial infarction within 60 days prior to the ablation procedure.
- Any percutaneous coronary intervention within 60 days prior to the ablation procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ablation procedure with DuoVT PFA systemcardiac ablation procedures with PFA and radiofrequency therapy settings (DuoVT PFA system ) | Device | frequent premature ventricular complexes & sustained monomorphic ventricular tachycardia group |
Primary outcome
Proportion of Subjects Experiencing a Device- and/or Procedure-Related Primary Safety Adverse Event Within 7 Days
Time frame: 7 days
the proportion of subjects experiencing one or more predefined Primary Safety Adverse Events (PSAEs) that are determined to be definitely related to the device and/or procedure, with onset within 7 days of the index ablation procedure
Non-inducibility of Targeted Clinical SMMVT Following Index Ablation Procedure (< 200 BPM)
Time frame: at the end of the procedure
Non-inducibility of the targeted clinical sustain monomorphic ventricular tachycardia (SMMVT) at the end of the index ablation procedure. Non-inducibility of targeted clinical SMMVT(s) slower than 200 bpm (CL 300 ms)
Elimination of Targeted Clinical PVC Following Index Ablation Procedure (reassessment for spontaneous PVCs and repeat pacing post ablation).
Time frame: at the end of the procedure following a 20-minute wait period
Elimination of targeted clinical premature ventricular complex (PVC) at the end of the index ablation procedure following a 20-minute wait period. Post-ablation testing should be performed to confirm effectiveness and should include reassessment for spontaneous PVCs and repeat pacing if it was used initially.
2 secondary outcomes
Freedom from Recurrent SMMVT Without Antiarrhythmic Drug Escalation Through 6 Months
Time frame: 6Months visit
Achievement of PVC Burden <2% as Assessed by 24-Hour Holter Monitoring at 6 Months
Time frame: 6Months visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
Related trials for Ventricular Tachycardia
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Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
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RecruitingObservational study
AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
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MRI-guided Ventricular Tachycardia Ablation in Patients With Structural Heart Disease
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A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christine Sasaridis contact
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation procedure with DuoVT PFA system in people with Ventricular Tachycardia, run by Abbott Medical Devices at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 48 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy, Croatia, Czechia, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maxime De Groof, MMD (+32 2 774 68 59, maxime.degroof@abbott.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Subjects Experiencing a Device- and/or Procedure-Related Primary Safety Adverse Event Within 7 Days (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.