Tachycardia, VentricularSERF-VTNCT02994446
Saline-Enhanced Radiofrequency (SERF) Catheter Ablation for the Treatment of Ventricular Tachycardia
A study testing Saline-Enhanced Radiofrequency Catheter and Ablation System in people with Tachycardia, Ventricular, run by Thermedical, Inc. at 3 sites in Canada.
Trial summary
The purpose of this study is to demonstrate the technical feasibility of the SERF Catheter and SERF Cardiac Ablation System to eliminate or control ventricular tachycardia (VT) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachycardia, Ventricular
- What is being tested?
- Saline-Enhanced Radiofrequency Catheter and Ablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesCanada
- Study dates
- Dec 2016to 4 Oct 2021
- 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
- Patient has recurrent, symptomatic, monomorphic VT
- Patient has drug refractory or drug intolerant 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
- A prior failed ablation as evidenced by ICD device therapy within the prior 6 months.
- Patient has minimum 3 month ICD interrogation history available for evaluation
- Patient has LVEF > 20%, confirmed by echo or comparable technique during baseline evaluation
- Patient is at least 18 years old
- Patient has signed the informed consent, and is willing and able to participate in all study procedures and follow up requirements
Who cannot join
- Patients with idiopathic VT
- Patients with VT with ECG or MRI/CT findings suggestive of right ventricular free wall origin findings.
- Patients with VTs of septal origin may be excluded as such ablations require special care to minimize the risk of heart block, particularly within 2 cm of the AV node/proximal conduction system. Patients requiring ablation at such locations should only be included when the arrhythmia itself is life-threatening or otherwise sufficiently severe to justify the risk.
- Patient with myocardial infarction (MI) or unstable angina within previous 60 days
- Patient with cardiac surgery or percutaneous coronary intervention (PCI) within previous 60 days
- Patient with class IV (NYHA) heart failure
Show all 16Show fewer
- Patient with mechanical mitral valve, severe aortic stenosis or flail mitral leaflet
- Patient with left ventricular assist device planned or required for the procedure
- Patients with co-morbidities such that they have less than 1 year life expectancy
- Patient with significant intracardiac and/or laminated thrombus evident by transesophogeal echo (TEE) or transthoracic echo (TTE) (with contrast) within 2 days of the ablation procedure
- Patient with thrombocytopenia or other coagulopathy
- Women who are or may potentially be pregnant. (must be post-menopausal or have a negative pregnancy test)
- Patient with other acute illness or active systemic infection (unrelated to VT or its origin)
- Significant congenital anomaly heart disease or anomaly
- Allergy or contraindications to the medications/agents used during a standard ablation/EP intervention.
- Patient 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.
Canada3 sites
Montreal Heart Institute - Institut de Cardiologie de Montréal
Montreal, Quebec, H1T 1C8
Southlake Regional Health Centre
Newmarket, Ontario, L3Y-2P6
Quebec Heart and Lung Institute - Institut universitaire de cardiologie et de pneumologie de Québec
Québec
About this study
The purpose of this study is to demonstrate the technical feasibility of the SERF Catheter and SERF Cardiac Ablation System to eliminate or control ventricular tachycardia (VT)
- Conditions
- Tachycardia, Ventricular
- Being tested
- Saline-Enhanced Radiofrequency Catheter and Ablation System
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline-Enhanced Radiofrequency Catheter and Ablation SystemDevice
Also called SERF Ablation System and Durablate™ Ablation Catheter
Ablation of ventricular tachycardia with a saline-enhanced radiofrequency ablation catheter
| Study group | Role | What they receive |
|---|---|---|
| SERF Catheter Ablation | Experimental | Ablation of ventricular tachycardia with a saline-enhanced radiofrequency ablation catheter Receives: Device: Saline-Enhanced Radiofrequency Catheter and Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Events that are potentially device-related
Measured: Within 30 days of ablation
Major Adverse Cardiac Events
MACE will be accessed from time of ablation to time of discharge from hospital following the ablation (generally within 2 days of ablation procedure).
Measured: Within 2 days after ablation procedure
Non-inducibility of clinical ventricular tachycardia (VT) and/or elimination of clinically relevant scar or channels
Measured: At completion of ablation procedure
Secondary outcomes (2)
Intraprocedural non-inducibility and/or scar homogenization of target VT
Measured: At completion of ablation procedure
Elimination of the target VT and/or reduction in number of VT episodes
Measured: Within first 6 months of ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study startDec 2016
- Primary completion21 Apr 2021
- Study completion4 Oct 2021
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 Tachycardia, VentricularStudies 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
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thermedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Douglas L. Packer, MD, Study director, Mayo ClinicAtul Verma, MD, Principal investigator, Southlake Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994446
- Sponsor's protocol ID
- RD-14-001P
- Acronym
- SERF-VT
- Status last verified
- Apr 2022
- First submitted
- 11 Dec 2016
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saline-Enhanced Radiofrequency (SERF) Catheter Ablation for the Treatment of Ventricular Tachycardia
- ClinicalTrials.gov ID
- NCT02994446
- Acronym / sponsor ID
- SERF-VT / RD-14-001P
- Conditions
- Tachycardia, Ventricular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Thermedical, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2016 (actual)
- Primary completion
- 21 Apr 2021 (actual)
- Study completion
- 4 Oct 2021 (actual)
- First posted
- 15 Dec 2016 (estimated)
- 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.
The purpose of this study is to demonstrate the technical feasibility of the SERF Catheter and SERF Cardiac Ablation System to eliminate or control ventricular tachycardia (VT)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SERF Catheter Ablation | Experimental | Device: Saline-Enhanced Radiofrequency Catheter and Ablation SystemAblation 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 (7 listed)
- Patient has recurrent, symptomatic, monomorphic VT
- Patient has drug refractory or drug intolerant 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
- A prior failed ablation as evidenced by ICD device therapy within the prior 6 months.
- Patient has minimum 3 month ICD interrogation history available for evaluation
- Patient has LVEF > 20%, confirmed by echo or comparable technique during baseline evaluation
Key exclusion criteria (16 listed)
- Patients with idiopathic VT
- Patients with VT with ECG or MRI/CT findings suggestive of right ventricular free wall origin findings.
- Patients with VTs of septal origin may be excluded as such ablations require special care to minimize the risk of heart block, particularly within 2 cm of the AV node/proximal conduction system. Patients requiring ablation at such locations should only be included when the arrhythmia itself is life-threatening or otherwise sufficiently severe to justify the risk.
- Patient with myocardial infarction (MI) or unstable angina within previous 60 days
- Patient 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 Catheter and Ablation SystemAlso: SERF Ablation System and Durablate™ Ablation CatheterAblation of ventricular tachycardia with a saline-enhanced radiofrequency ablation catheter | Device | SERF Catheter Ablation |
Primary outcome
Serious Adverse Events that are potentially device-related
Time frame: Within 30 days of ablation
Major Adverse Cardiac Events
Time frame: Within 2 days after ablation procedure
MACE will be accessed from time of ablation to time of discharge from hospital following the ablation (generally within 2 days of ablation procedure).
Non-inducibility of clinical ventricular tachycardia (VT) and/or elimination of clinically relevant scar or channels
Time frame: At completion of ablation procedure
2 secondary outcomes
Intraprocedural non-inducibility and/or scar homogenization of target VT
Time frame: At completion of ablation procedure
Elimination of the target VT and/or reduction in number of VT episodes
Time frame: Within first 6 months of ablation procedure
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 28 Apr 2022.
- Derived from this study: 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.
- Individual participant dataSharing planned: Undecided
Related trials for Tachycardia, Ventricular
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
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)
Tachycardia, Ventricular
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 L. Packer, MD study director
Mayo Clinic
Atul Verma, MD principal investigator
Southlake Health
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 Catheter and Ablation System in people with Tachycardia, Ventricular, run by Thermedical, Inc. at 3 sites in Canada.
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 7 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 28 Apr 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 Canada. 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?
Serious Adverse Events that are potentially device-related (time frame: Within 30 days of ablation). 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?
On the ClinicalTrials.gov record for NCT02994446, 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 28 Apr 2022.