Ventricular ArrythmiaNCT03204981
Intramural Needle Ablation for the Treatment of Refractory Ventricular Arrhythmias
A study testing Intramural Needle Ablation and Ablation in people with Ventricular Arrythmia, run by Vivek Reddy at 1 site in United States.
Trial summary
This study will examine the safety and efficacy of intramural needle ablation (INA) in the treatment of intramural ventricular arrhythmias in patients for whom standard RF ablation has been unsuccessful. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Ventricular Arrythmia
- What is being tested?
- Intramural Needle Ablation and Ablation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2017to 20 Apr 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The study will include patients with any of the following criteria: a) monomorphic ventricular tachycardia (VT); b) frequent ventricular arrhythmia (defined as unifocal PVCs, couplets, non-sustained VT) with a PVC burden ≥13%, or is causing a decline in left ventricular (LV) ejection fraction to <40%; or c) previous failed ablation for one or more of the criteria above.
- ≥ 15 years of age.
- Left ventricular (LV) ejection fraction > 10% as estimated by echocardiography, contrast ventriculography or radionuclide imaging within the past 90 days.
- Clinical indication for catheter ablation of VT
- Intramural ventricular arrhythmias not terminable with standard ablation once enrolled in the Intramural Needle Ablation study or previous failed ablation within 6 months prior to enrollment.
- Ability to understand the requirements of the study and sign the informed consent form.
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements.
- Projected lifespan greater than 1 year.
Who cannot join
- History of MI or CABG within 6 weeks.
- NYHA Class IV CHF.
- Patients with idiopathic ventricular arrhythmias defined as VT or PVCs that occur without evidence of structural heart disease and that are not causing significant depression of LV function.
- Women known to be pregnant or to have positive beta-HCG.
- Definite protruding left ventricular thrombus on pre-ablation echocardiography or other imaging modalities.
- Contraindication to heparin
Show all 13Show fewer
- Allergy to radiographic contrast dye.
- Unstable angina that is not due to frequent or incessant VT.
- Acute non-cardiovascular illness or systemic infection.
- Thrombocytopenia (platelet count < 50,000 mm3) or coagulopathy.
- Cardiogenic shock unless it is due to incessant VT.
- Unable to sign consent.
- Projected lifespan of < 1 year.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
This study will examine the safety and efficacy of intramural needle ablation (INA) in the treatment of intramural ventricular arrhythmias in patients for whom standard RF ablation has been unsuccessful. The clinical team hypothesize that the increased current density and improved rates of transmural lesion creation seen with intramural needle ablation will lead to successful arrhythmia termination with minimal or no increased risk of complication.
Read the detailed description
Radiofrequency (RF) ablation is the most commonly employed method for the catheter treatment of cardiac arrhythmias. Myocardial scar serves as the most frequent substrate for the genesis of both atrial and ventricular arrhythmias. Such scar frequently contains surviving myocyte bundles interspersed with fibrotic tissue, which leads to slow conduction. Areas of denser fibrosis cause conduction block. When appropriately arranged, conduction through or around these scars leads to the creation of a "reentry" circuit through which an arrhythmia is generated and maintained. Each reentry circuit contains within it an area called the isthmus, a portion of the circuit located in a position intimately related to the scar border zone. Electrical activation travels slowly through the isthmus before breaking out into normal myocardium. Ablation at the site of an isthmus will terminate a reentrant tachycardia.
A variety of techniques, including electroanatomic mapping and activation, entrainment, and substrate mapping, are employed during electrophysiologic (EP) study to identify areas of myocardial scar and potential isthmus sites. Points or lines of ablation using RF energy are then created in an attempt to interrupt the reentry circuit. Typically, RF energy is applied via a catheter tip electrode to the endocardial or epicardial surface of the heart and grounded via an electrode pad placed on the patient's skin. RF energy in this setting is dispersed through the entirety of the tissue between catheter tip and grounding pad. The standard 7-French, 4-mm tip catheters are highly successful at ablating circuits located within a few millimeters of the catheter tip. A focal, 1mm area of resistive heating occurs within the myocardium immediately in contact with the catheter tip; myocardial cell death occurs several millimeters more deeply through passive, conductive heating, which spreads outward from the contact point.
While the standard catheter is effective at the ablation of superficial arrhythmias, it has proven more problematic when used for deep myocardial sites or for creating transmural lesions. A number of alternatives have been developed in an attempt to access these sites. 8-mm or 10-mm catheter tips are able to create larger zones of resistive heating, delivering direct RF energy to a larger area of myocardium. A larger interface between catheter tip and blood improves cooling and allows for the delivery of more power without a rise in impedance.The clinical use of these larger catheters can, however, be limited by rapid temperature rises at the catheter-tissue interface, resulting in thrombus formation, char, and "steam pop" rupture of the endocardial surface. The use of irrigated ablation catheters have improved upon the ability to deliver RF energy without a sustained rise in impedance. Both open irrigated- and closed-loop irrigated catheters circulate saline along the catheter tip-myocardial interface, allowing for continued delivery of RF current without thrombus formation at the endocardial surface. Intramyocardial temperature rises accordingly without a concomitant endocardial temperature surge, creating larger and deeper myocardial ablation zones. Transcoronary ethanol ablation has also been employed with moderate success in patients with arrhythmias resistant to endocardial catheter ablation.This technology, however, grants only limited control over the size of the resulting infarct and is restricted by the need for perfusion of the scar zone by an accessible coronary artery.
Nevertheless, there remain occasions in which an arrhythmia cannot be eliminated by standard ablation techniques. This is seen most frequently due to deep intramural ventricular tachycardia, sometimes encountered following myocardial infarction. Both standard and alternative ablation strategies are frequently either unavailable or inadequate for termination of these arrhythmias.
Initial experience with an electrically active needle electrode have demonstrated that radiofrequency ablative energy can effectively create lesions of homogeneous necrosis. Needle electrodes have been used experimentally from the epicardial surface, from the endocardium ex vivo and in vivo in an internally irrigated form. It has been shown that the use of a narrow-gauge non-irrigated endocardial needle ablation catheter creates very narrow but deep lesions due to the small electrode size. Catheters featuring a retractable needle tipped electrode with intramyocardial saline infusion have also shown promise as a means of accessing deep myocardial circuits in ventricular tachycardia ablation.18
The proposed study will further examine the role of INA in patients with ventricular arrhythmias resistant to standard ablation techniques.
- Conditions
- Ventricular Arrythmia
- Being tested
- Intramural Needle Ablation, Ablation
- Keywords
- intramural needle ablation, ventricular arrhythmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramural Needle AblationDevice
The needle-tipped ablation catheter that will be used for the IN ablation uses radiofrequency like a standard RF ablation catheter, but delivers energy through an extendable/retractable needle.
AblationProcedure or surgery
standard ablation
| Study group | Role | What they receive |
|---|---|---|
| Intramural Needle Ablation | Experimental | Not described Receives: Device: Intramural Needle Ablation; Procedure: Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Had Freedom From Ventricular Arrhythmia at 6 Months
Number of participants with VT and number of participants with PVCs who had freedom from ventricular arrhythmia at 6 months for participants who had ablation performed using the experimental Needle ablation catheter versus standard ablation catheter.
Needle - patient had ablation performed using the experimental Needle ablation catheter.
Registry - patient had ablation using a standard ablation catheter and did not need additional ablation using the Needle catheter.
Measured: 6 months
Secondary outcomes (6)
Number of Events of Procedural Complications
Number of events of procedural complications
Measured: at 6 months
Number of Participants With Post-ablation Inducibility
Measured: Day 1
Time to Termination
Measured: Day 1
Total Duration of Intramural Needle Ablation
Total duration of intramural needle ablation for patient who had ablation performed using the experimental Needle ablation catheter.
Measured: Day 1
Total Number of Intramural Needle Ablations
Total Number of Intramural Needle Ablations for patient had ablation performed using the experimental Needle ablation catheter.
Measured: Day 1
All-cause Mortality
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start17 Oct 2017
- Primary completion20 Apr 2021
- Study completion20 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ventricular ArrythmiaStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vivek Reddy
- Sponsor type
- University, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Responsible party
- Sponsor-investigator, Vivek Reddy, Icahn School of Medicine at Mount Sinai
- Investigators
- Vivek Reddy, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03204981
- Sponsor's protocol ID
- GCO 17-1899
- Status last verified
- Sep 2021
- First submitted
- 28 Jun 2017
- Last updated
- 12 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Tedrow UB, Kurata M, Kawamura I, Batnyam U, Dukkipati S, Nakamura T, Tanigawa S, Fuji A, Richardson TD, Kanagasundram AN, Koruth JS, John RM, Hasegawa K, Abdelwahab A, Sapp J, Reddy VY, Stevenson WG. Worldwide Experience With an Irrigated Needle Catheter for Ablation of Refractory Ventricular Arrhythmias: Final Report. JACC Clin Electrophysiol. 2023 Aug;9(8 Pt 2):1475-1486. doi: 10.1016/j.jacep.2023.05.014. Epub 2023 May 19.
PubMed 37278684Dukkipati SR, Nakamura T, Nakajima I, Oates C, Narui R, Tanigawa S, Sljapic T, Whang W, Koruth JS, Choudry S, Schaeffer B, Fujii A, Tedrow UB, Sapp JL, Stevenson WG, Reddy VY. Intramural Needle Ablation for Refractory Premature Ventricular Contractions. Circ Arrhythm Electrophysiol. 2022 May;15(5):e010020. doi: 10.1161/CIRCEP.121.010020. Epub 2022 Apr 27.
PubMed 35476455
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intramural Needle Ablation for the Treatment of Refractory Ventricular Arrhythmias
- ClinicalTrials.gov ID
- NCT03204981
- Acronym / sponsor ID
- GCO 17-1899
- Conditions
- Ventricular Arrythmia
- Keywords
- intramural needle ablation, ventricular arrhythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Vivek ReddyUniversity, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 20 Apr 2021 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Posted 12 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the safety and efficacy of intramural needle ablation (INA) in the treatment of intramural ventricular arrhythmias in patients for whom standard RF ablation has been unsuccessful. The clinical team hypothesize that the increased current density and improved rates of transmural lesion creation seen with intramural needle ablation will lead to successful arrhythmia termination with minimal or no increased risk of complication.
Detailed description
Radiofrequency (RF) ablation is the most commonly employed method for the catheter treatment of cardiac arrhythmias. Myocardial scar serves as the most frequent substrate for the genesis of both atrial and ventricular arrhythmias. Such scar frequently contains surviving myocyte bundles interspersed with fibrotic tissue, which leads to slow conduction. Areas of denser fibrosis cause conduction block. When appropriately arranged, conduction through or around these scars leads to the creation of a "reentry" circuit through which an arrhythmia is generated and maintained. Each reentry circuit contains within it an area called the isthmus, a portion of the circuit located in a position intimately related to the scar border zone. Electrical activation travels slowly through the isthmus before breaking out into normal myocardium. Ablation at the site of an isthmus will terminate a reentrant tachycardia.
A variety of techniques, including electroanatomic mapping and activation, entrainment, and substrate mapping, are employed during electrophysiologic (EP) study to identify areas of myocardial scar and potential isthmus sites. Points or lines of ablation using RF energy are then created in an attempt to interrupt the reentry circuit. Typically, RF energy is applied via a catheter tip electrode to the endocardial or epicardial surface of the heart and grounded via an electrode pad placed on the patient's skin. RF energy in this setting is dispersed through the entirety of the tissue between catheter tip and grounding pad. The standard 7-French, 4-mm tip catheters are highly successful at ablating circuits located within a few millimeters of the catheter tip. A focal, 1mm area of resistive heating occurs within the myocardium immediately in contact with the catheter tip; myocardial cell death occurs several millimeters more deeply through passive, conductive heating, which spreads outward from the contact point.
While the standard catheter is effective at the ablation of superficial arrhythmias, it has proven more problematic when used for deep myocardial sites or for creating transmural lesions. A number of alternatives have been developed in an attempt to access these sites. 8-mm or 10-mm catheter tips are able to create larger zones of resistive heating, delivering direct RF energy to a larger area of myocardium. A larger interface between catheter tip and blood improves cooling and allows for the delivery of more power without a rise in impedance.The clinical use of these larger catheters can, however, be limited by rapid temperature rises at the catheter-tissue interface, resulting in thrombus formation, char, and "steam pop" rupture of the endocardial surface. The use of irrigated ablation catheters have improved upon the ability to deliver RF energy without a sustained rise in impedance. Both open irrigated- and closed-loop irrigated catheters circulate saline along the catheter tip-myocardial interface, allowing for continued delivery of RF current without thrombus formation at the endocardial surface. Intramyocardial temperature rises accordingly without a concomitant endocardial temperature surge, creating larger and deeper myocardial ablation zones. Transcoronary ethanol ablation has also been employed with moderate success in patients with arrhythmias resistant to endocardial catheter ablation.This technology, however, grants only limited control over the size of the resulting infarct and is restricted by the need for perfusion of the scar zone by an accessible coronary artery.
Nevertheless, there remain occasions in which an arrhythmia cannot be eliminated by standard ablation techniques. This is seen most frequently due to deep intramural ventricular tachycardia, sometimes encountered following myocardial infarction. Both standard and alternative ablation strategies are frequently either unavailable or inadequate for termination of these arrhythmias.
Initial experience with an electrically active needle electrode have demonstrated that radiofrequency ablative energy can effectively create lesions of homogeneous necrosis. Needle electrodes have been used experimentally from the epicardial surface, from the endocardium ex vivo and in vivo in an internally irrigated form. It has been shown that the use of a narrow-gauge non-irrigated endocardial needle ablation catheter creates very narrow but deep lesions due to the small electrode size. Catheters featuring a retractable needle tipped electrode with intramyocardial saline infusion have also shown promise as a means of accessing deep myocardial circuits in ventricular tachycardia ablation.18
The proposed study will further examine the role of INA in patients with ventricular arrhythmias resistant to standard ablation techniques.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intramural Needle Ablation | Experimental | Device: Intramural Needle Ablation, Procedure: Ablation |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- The study will include patients with any of the following criteria: a) monomorphic ventricular tachycardia (VT); b) frequent ventricular arrhythmia (defined as unifocal PVCs, couplets, non-sustained VT) with a PVC burden ≥13%, or is causing a decline in left ventricular (LV) ejection fraction to <40%; or c) previous failed ablation for one or more of the criteria above.
- ≥ 15 years of age.
- Left ventricular (LV) ejection fraction > 10% as estimated by echocardiography, contrast ventriculography or radionuclide imaging within the past 90 days.
- Clinical indication for catheter ablation of VT
- Intramural ventricular arrhythmias not terminable with standard ablation once enrolled in the Intramural Needle Ablation study or previous failed ablation within 6 months prior to enrollment.
Key exclusion criteria (13 listed)
- History of MI or CABG within 6 weeks.
- NYHA Class IV CHF.
- Patients with idiopathic ventricular arrhythmias defined as VT or PVCs that occur without evidence of structural heart disease and that are not causing significant depression of LV function.
- Women known to be pregnant or to have positive beta-HCG.
- Definite protruding left ventricular thrombus on pre-ablation echocardiography or other imaging modalities.
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 |
|---|---|---|
| Intramural Needle AblationThe needle-tipped ablation catheter that will be used for the IN ablation uses radiofrequency like a standard RF ablation catheter, but delivers energy through an extendable/retractable needle. | Device | Intramural Needle Ablation |
| Ablationstandard ablation | Procedure or surgery | Intramural Needle Ablation |
Primary outcome
Number of Participants Who Had Freedom From Ventricular Arrhythmia at 6 Months
Time frame: 6 months
Number of participants with VT and number of participants with PVCs who had freedom from ventricular arrhythmia at 6 months for participants who had ablation performed using the experimental Needle ablation catheter versus standard ablation catheter. Needle - patient had ablation performed using the experimental Needle ablation catheter. Registry - patient had ablation using a standard ablation catheter and did not need additional ablation using the Needle catheter.
6 secondary outcomes
Number of Events of Procedural Complications
Time frame: at 6 months
Number of Participants With Post-ablation Inducibility
Time frame: Day 1
Time to Termination
Time frame: Day 1
Total Duration of Intramural Needle Ablation
Time frame: Day 1
Total Number of Intramural Needle Ablations
Time frame: Day 1
All-cause Mortality
Time frame: at 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37278684Tedrow UB, Kurata M, Kawamura I, Batnyam U, Dukkipati S, Nakamura T, Tanigawa S, Fuji A, Richardson TD, Kanagasundram AN, Koruth JS, John RM, Hasegawa K, Abdelwahab A, Sapp J, Reddy VY, Stevenson WG. Worldwide Experience With an Irrigated Needle Catheter for Ablation of Refractory Ventricular Arrhythmias: Final Report. JACC Clin Electrophysiol. 2023 Aug;9(8 Pt 2):1475-1486. doi: 10.1016/j.jacep.2023.05.014. Epub 2023 May 19.
- Derived from this study: PubMed 35476455Dukkipati SR, Nakamura T, Nakajima I, Oates C, Narui R, Tanigawa S, Sljapic T, Whang W, Koruth JS, Choudry S, Schaeffer B, Fujii A, Tedrow UB, Sapp JL, Stevenson WG, Reddy VY. Intramural Needle Ablation for Refractory Premature Ventricular Contractions. Circ Arrhythm Electrophysiol. 2022 May;15(5):e010020. doi: 10.1161/CIRCEP.121.010020. Epub 2022 Apr 27.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Vivek Reddy, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intramural Needle Ablation and Ablation in people with Ventricular Arrythmia, run by Vivek Reddy at 1 site 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 13 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 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 12 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Had Freedom From Ventricular Arrhythmia at 6 Months (time frame: 6 months). 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 NCT03204981, which also lists 2 linked publications.
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 12 Oct 2021.