Ventricular TachycardiaSERF VT EFSNCT03628534
SERF VT Ablation Early Feasibility Study (EFS)
A study testing Saline Enhanced Radiofrequency (SERF) ablation in people with Ventricular Tachycardia and Arrythmia, run by Thermedical, Inc. at 3 sites in United States.
Trial summary
This is an early feasibility, non-randomized, open-label, single group, interventional study to be conducted in up to 20 US subjects to evaluate the technical feasibility of the Durablate Catheter and Thermedical Ablation System to eliminate or control sustained, monomorphic ventricular tachycardia (VT) in patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, Arrythmia, Heart Diseases
- What is being tested?
- Saline Enhanced Radiofrequency (SERF) ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Nov 2018to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has sustained, monomorphic VT
- Subject has recurrent, symptomatic VT
- Subject has drug refractory or drug intolerant sustained VT following use of at least one Class III antiarrhythmic as demonstrated by a recurrent arrhythmia and is not a suitable candidate per the investigator's expert opinion for ongoing or alternative drug therapy
- ECG and/or ICD evidence of a spontaneous VT recurrence within the prior 6 months that is suspected to be the same VT as initially targeted in a prior ablation
- Subject has minimum 3-month ICD interrogation history available for evaluation
- Subject has LVEF > 20%, confirmed by echo or comparable technique during baseline evaluation
- Subject is at least 18 years old
- Subject has signed the informed consent, and is willing and able to participate in all study procedures and follow up requirements
Who cannot join
- Subjects with VT of idiopathic origin
- Subjects with VT with ECG or MRI/CT findings suggestive of right ventricular free wall origin
- Subjects with VTs of septal origin require special care to minimize the risk of heart block, particularly within 2 cm of the AV node/proximal conduction system; Subjects requiring ablation at such locations should only be included when the arrhythmia itself is life-threatening or otherwise sufficiently severe to justify the risk
- Subject with myocardial infarction (MI) or unstable angina within previous 60 days
- Subject with cardiac surgery or percutaneous coronary intervention (PCI) within previous 60 days
- Subject with class IV (NYHA) heart failure
Show all 16Show fewer
- Subject with prosthetic cardiac valve(s), severe aortic stenosis or flail mitral valve
- Subject with left ventricular assist device planned or required for the procedure
- Subjects with co-morbidities such that they have less than 1-year life expectancy
- Subject with evidence of intracardiac and/or laminated thrombus (in the left atrium including left atrial appendage or the left ventricle) evident by cardiac CT or transesophageal echo (TEE) and transthoracic echo (TTE) (with contrast if indicated) within 48 hours prior to ablation procedure
- Subject with thrombocytopenia or other coagulopathy
- Women who are or may potentially be pregnant (must be post-menopausal or have a negative pregnancy test)
- Subject with other acute illness or active systemic infection (unrelated to VT or its origin)
- Significant congenital heart disease or cardiac anomaly
- Allergy or contraindications to the medications/agents used during a standard ablation/EP intervention.
- Subject concurrently enrolled in any other investigational drug or device study that the investigator deems would interfere with study results
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Loyola University Medical Center
Maywood, Illinois, 60153
Vanderbilt Heart
Nashville, Tennessee, 37232
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Saline Enhanced Radiofrequency (SERF) VT Ablation Early Feasibility Study (EFS)
This is an early feasibility, non-randomized, open-label, single group, interventional study to be conducted in up to 20 US subjects to evaluate the technical feasibility of the Durablate Catheter and Thermedical Ablation System to eliminate or control sustained, monomorphic ventricular tachycardia (VT) in patients with VT refractory to drug and conventional catheter ablation with acceptable procedural safety.
Read the detailed description
The purpose of this study is to gather information on the technical feasiability and safety of a needle ablation catheter called the Durablate™ Saline Enhanced Radiofrequency (SERF) catheter. This catheter is being studied to treat ventricular tachycardia (VT) in patients who have already been treated with medicine, have an Implantable Cardioverter Defibrillator (ICD) and had an ablation procedure to treat their VT but continue to experience VT despite these treatments. A VT ablation procedure is done by finding the abnormal heart tissue that's causing the VT and applying energy with the tip of an ablation catheter to the area to create a scar or destroy the tissue that causes the VT. The SERF catheter being used in this study uses a needle to deliver heated saline (salt water) and radiofrequency energy deeper into the heart tissue that is causing the VT than a standard ablation catheter.
- Being tested
- Saline Enhanced Radiofrequency (SERF) ablation
- Keywords
- Cardiac Arrhythmia, Ventricular Tachycardia, Arrhythmia, Pathological processes
- Medical subject headings
- Tachycardia, Ventricular, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Pathologic Processes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline Enhanced Radiofrequency (SERF) ablationDevice
Also called Durablate Catheter and Thermedical Ablation System
Ablation of ventricular tachycardia with a saline-enhanced radiofrequency ablation catheter
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | Ablation of ventricular tachycardia with a saline-enhanced radiofrequency ablation catheter Receives: Device: Saline Enhanced Radiofrequency (SERF) ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
EFFICACY: Non-inducibility of the targeted clinical VT at end of ablation procedure.
Completion of intended ablation during treatment setting as measured by non-inducibility of the targeted clinical VT (acute procedural success).
Measured: By the end of the procedure
SAFETY: SAEs that are probably or definitely device related within 30 days
Measured: within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start1 Nov 2018
- Primary completion30 Jun 2021
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- 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
- Model description
- Thermedical SERF Ablation System and Durablate Catheter
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thermedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Douglas Packer, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628534
- Sponsor's protocol ID
- CP-100
- Other IDs
- 1R44HL132746-01A1
- Acronym
- SERF VT EFS
- Status last verified
- Aug 2022
- First submitted
- 26 Jul 2018
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Packer DL, Wilber DJ, Kapa S, Dyrda K, Nault I, Killu AM, Kanagasundram A, Richardson T, Stevenson W, Verma A, Curley M; SERF Investigators. Ablation of Refractory Ventricular Tachycardia Using Intramyocardial Needle Delivered Heated Saline-Enhanced Radiofrequency Energy: A First-in-Man Feasibility Trial. Circ Arrhythm Electrophysiol. 2022 Aug;15(8):e010347. doi: 10.1161/CIRCEP.121.010347. Epub 2022 Jul 1.
PubMed 35776711
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saline Enhanced Radiofrequency (SERF) VT Ablation Early Feasibility Study (EFS)
- ClinicalTrials.gov ID
- NCT03628534
- Acronym / sponsor ID
- SERF VT EFS / CP-100
- Keywords
- Cardiac Arrhythmia, Ventricular Tachycardia, Arrhythmia, Pathological processes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Thermedical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 14 Aug 2018 (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 is an early feasibility, non-randomized, open-label, single group, interventional study to be conducted in up to 20 US subjects to evaluate the technical feasibility of the Durablate Catheter and Thermedical Ablation System to eliminate or control sustained, monomorphic ventricular tachycardia (VT) in patients with VT refractory to drug and conventional catheter ablation with acceptable procedural safety.
Detailed description
The purpose of this study is to gather information on the technical feasiability and safety of a needle ablation catheter called the Durablate™ Saline Enhanced Radiofrequency (SERF) catheter. This catheter is being studied to treat ventricular tachycardia (VT) in patients who have already been treated with medicine, have an Implantable Cardioverter Defibrillator (ICD) and had an ablation procedure to treat their VT but continue to experience VT despite these treatments. A VT ablation procedure is done by finding the abnormal heart tissue that's causing the VT and applying energy with the tip of an ablation catheter to the area to create a scar or destroy the tissue that causes the VT. The SERF catheter being used in this study uses a needle to deliver heated saline (salt water) and radiofrequency energy deeper into the heart tissue that is causing the VT than a standard ablation catheter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Thermedical SERF Ablation System and Durablate Catheter
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Device: Saline Enhanced Radiofrequency (SERF) ablationAblation of ventricular tachycardia with a saline-enhanced radiofrequency ablation catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject has sustained, monomorphic VT
- Subject has recurrent, symptomatic VT
- Subject has drug refractory or drug intolerant sustained VT following use of at least one Class III antiarrhythmic as demonstrated by a recurrent arrhythmia and is not a suitable candidate per the investigator's expert opinion for ongoing or alternative drug therapy
- ECG and/or ICD evidence of a spontaneous VT recurrence within the prior 6 months that is suspected to be the same VT as initially targeted in a prior ablation
- Subject has minimum 3-month ICD interrogation history available for evaluation
Key exclusion criteria (16 listed)
- Subjects with VT of idiopathic origin
- Subjects with VT with ECG or MRI/CT findings suggestive of right ventricular free wall origin
- Subjects with VTs of septal origin require special care to minimize the risk of heart block, particularly within 2 cm of the AV node/proximal conduction system; Subjects requiring ablation at such locations should only be included when the arrhythmia itself is life-threatening or otherwise sufficiently severe to justify the risk
- Subject with myocardial infarction (MI) or unstable angina within previous 60 days
- Subject with cardiac surgery or percutaneous coronary intervention (PCI) within previous 60 days
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 |
|---|---|---|
| Saline Enhanced Radiofrequency (SERF) ablationAlso: Durablate Catheter and Thermedical Ablation SystemAblation of ventricular tachycardia with a saline-enhanced radiofrequency ablation catheter | Device | single arm |
Primary outcome
EFFICACY: Non-inducibility of the targeted clinical VT at end of ablation procedure.
Time frame: By the end of the procedure
Completion of intended ablation during treatment setting as measured by non-inducibility of the targeted clinical VT (acute procedural success).
SAFETY: SAEs that are probably or definitely device related within 30 days
Time frame: within 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Results publication: PubMed 35776711Packer DL, Wilber DJ, Kapa S, Dyrda K, Nault I, Killu AM, Kanagasundram A, Richardson T, Stevenson W, Verma A, Curley M; SERF Investigators. Ablation of Refractory Ventricular Tachycardia Using Intramyocardial Needle Delivered Heated Saline-Enhanced Radiofrequency Energy: A First-in-Man Feasibility Trial. Circ Arrhythm Electrophysiol. 2022 Aug;15(8):e010347. doi: 10.1161/CIRCEP.121.010347. Epub 2022 Jul 1.
Related trials for Ventricular Tachycardia
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
RecruitingPhase 1
A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Catecholaminergic Polymorphic Ventricular Tachycardia
Recruiting
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Ventricular Tachycardia
Active, not recruiting
Combined Pulsed Field and Radiofrequency Energy for Ablation of Ventricular Tachycardia
Ventricular Tachycardia (V-Tach)
Recruiting
SPIKE FLOW Endocardial Lead Safety and Performance Study
Acute Myocardial Infarction (AMI), Asystole
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. This study is not recruiting at the moment.
Douglas Packer, MD principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline Enhanced Radiofrequency (SERF) ablation in people with Ventricular Tachycardia and Arrythmia, run by Thermedical, Inc. at 3 sites in United States.
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 8 inclusion and 16 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: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EFFICACY: Non-inducibility of the targeted clinical VT at end of ablation procedure. (time frame: By the end of the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03628534, which also lists 1 linked publication.
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 10 Aug 2022.