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Intramural Needle Ablation for the Treatment of Refractory Ventricular Arrhythmias

Intramural Needle Ablation for the Treatment of Refractory Ventricular Arrhythmias

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03204981
Enrollment
52
Registered
2017-07-02
Start date
2017-10-17
Completion date
2021-04-20
Last updated
2021-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventricular Arrythmia

Keywords

intramural needle ablation, ventricular arrhythmia

Brief 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. 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.

Interventions

DEVICEIntramural Needle Ablation

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.

PROCEDUREAblation

standard ablation

Sponsors

Biosense Webster, Inc.
CollaboratorINDUSTRY
Vivek Reddy
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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 * 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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Who Had Freedom From Ventricular Arrhythmia at 6 Months6 monthsNumber 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.

Secondary

MeasureTime frameDescription
Number of Participants With Post-ablation InducibilityDay 1
Time to TerminationDay 1
Number of Events of Procedural Complicationsat 6 monthsNumber of events of procedural complications
Total Number of Intramural Needle AblationsDay 1Total Number of Intramural Needle Ablations for patient had ablation performed using the experimental Needle ablation catheter.
All-cause Mortalityat 6 months
Total Duration of Intramural Needle AblationDay 1Total duration of intramural needle ablation for patient who had ablation performed using the experimental Needle ablation catheter.

Countries

United States

Participant flow

Participants by arm

ArmCount
Intramural Needle Ablation
Intramural Needle Ablation: 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. Ablation: standard ablation
52
Total52

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyPhysician Decision2
Overall StudyScreen failures (no inducible VT or PVCs)4

Baseline characteristics

CharacteristicIntramural Needle Ablation
Age, Continuous61.26 years
STANDARD_DEVIATION 16.83
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
46 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Patients with Premature Ventricular Contractions (PVCS)22 Participants
Patients with Ventricular Tachycardia (VT)24 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
1 Participants
Race (NIH/OMB)
Black or African American
4 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
6 Participants
Race (NIH/OMB)
White
41 Participants
Sex: Female, Male
Female
11 Participants
Sex: Female, Male
Male
41 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 52
other
Total, other adverse events
21 / 52
serious
Total, serious adverse events
15 / 52

Outcome results

Primary

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.

Time frame: 6 months

Population: participants analyzed for those with VT and those with PVCs

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants With VTNumber of Participants Who Had Freedom From Ventricular Arrhythmia at 6 MonthsNeedle8 Participants
Participants With VTNumber of Participants Who Had Freedom From Ventricular Arrhythmia at 6 MonthsRegistry5 Participants
Participants With PVCsNumber of Participants Who Had Freedom From Ventricular Arrhythmia at 6 MonthsNeedle4 Participants
Participants With PVCsNumber of Participants Who Had Freedom From Ventricular Arrhythmia at 6 MonthsRegistry2 Participants
Secondary

All-cause Mortality

Time frame: at 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants With VTAll-cause Mortality0 Participants
Secondary

Number of Events of Procedural Complications

Number of events of procedural complications

Time frame: at 6 months

Population: There were 21 participants that experienced a procedural complication event.

ArmMeasureValue (NUMBER)
Participants With VTNumber of Events of Procedural Complications29 events
Secondary

Number of Participants With Post-ablation Inducibility

Time frame: Day 1

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants With VTNumber of Participants With Post-ablation Inducibility2 Participants
Secondary

Time to Termination

Time frame: Day 1

Population: The researchers were only able to capture data on termination times for six patients. Many number of patients did not have termination. Others had termination, but the study team was not able to ascertain the time to termination.

ArmMeasureValue (MEAN)Dispersion
Participants With VTTime to Termination322.16 secondsStandard Deviation 189.91
Secondary

Total Duration of Intramural Needle Ablation

Total duration of intramural needle ablation for patient who had ablation performed using the experimental Needle ablation catheter.

Time frame: Day 1

Population: Data analyzed for participants who had experimental needle ablation.

ArmMeasureValue (MEAN)Dispersion
Participants With VTTotal Duration of Intramural Needle Ablation47.14 minutesStandard Deviation 40.51
Secondary

Total Number of Intramural Needle Ablations

Total Number of Intramural Needle Ablations for patient had ablation performed using the experimental Needle ablation catheter.

Time frame: Day 1

Population: Data analyzed for participants who had experimental needle ablation.

ArmMeasureValue (MEAN)Dispersion
Participants With VTTotal Number of Intramural Needle Ablations11.2 ablationsStandard Deviation 9

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026