Trial Outcomes & Findings for Intramural Needle Ablation for the Treatment of Refractory Ventricular Arrhythmias (NCT NCT03204981)
NCT ID: NCT03204981
Last Updated: 2021-10-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
6 months
Results posted on
2021-10-12
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
52
|
|
Overall Study
COMPLETED
|
46
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Screen failures (no inducible VT or PVCs)
|
4
|
Baseline Characteristics
Intramural Needle Ablation for the Treatment of Refractory Ventricular Arrhythmias
Baseline characteristics by cohort
| Measure |
Intramural Needle Ablation
n=52 Participants
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
|
|---|---|
|
Age, Continuous
|
61.26 years
STANDARD_DEVIATION 16.83 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
|
Patients with Ventricular Tachycardia (VT)
|
24 Participants
n=5 Participants
|
|
Patients with Premature Ventricular Contractions (PVCS)
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: participants analyzed for those with VT and those with PVCs
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.
Outcome measures
| Measure |
Participants With VT
n=24 Participants
Participants with Ventricular Tachycardia (VT)
|
Participants With PVCs
n=22 Participants
Participants with Premature Ventricular Contractions (PVCS)
|
|---|---|---|
|
Number of Participants Who Had Freedom From Ventricular Arrhythmia at 6 Months
Needle
|
8 Participants
|
4 Participants
|
|
Number of Participants Who Had Freedom From Ventricular Arrhythmia at 6 Months
Registry
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: at 6 monthsPopulation: There were 21 participants that experienced a procedural complication event.
Number of events of procedural complications
Outcome measures
| Measure |
Participants With VT
n=21 Participants
Participants with Ventricular Tachycardia (VT)
|
Participants With PVCs
Participants with Premature Ventricular Contractions (PVCS)
|
|---|---|---|
|
Number of Events of Procedural Complications
|
29 events
|
—
|
SECONDARY outcome
Timeframe: Day 1Outcome measures
| Measure |
Participants With VT
n=46 Participants
Participants with Ventricular Tachycardia (VT)
|
Participants With PVCs
Participants with Premature Ventricular Contractions (PVCS)
|
|---|---|---|
|
Number of Participants With Post-ablation Inducibility
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: 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.
Outcome measures
| Measure |
Participants With VT
n=6 Participants
Participants with Ventricular Tachycardia (VT)
|
Participants With PVCs
Participants with Premature Ventricular Contractions (PVCS)
|
|---|---|---|
|
Time to Termination
|
322.16 seconds
Standard Deviation 189.91
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Data analyzed for participants who had experimental needle ablation.
Total duration of intramural needle ablation for patient who had ablation performed using the experimental Needle ablation catheter.
Outcome measures
| Measure |
Participants With VT
n=29 Participants
Participants with Ventricular Tachycardia (VT)
|
Participants With PVCs
Participants with Premature Ventricular Contractions (PVCS)
|
|---|---|---|
|
Total Duration of Intramural Needle Ablation
|
47.14 minutes
Standard Deviation 40.51
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Data analyzed for participants who had experimental needle ablation.
Total Number of Intramural Needle Ablations for patient had ablation performed using the experimental Needle ablation catheter.
Outcome measures
| Measure |
Participants With VT
n=29 Participants
Participants with Ventricular Tachycardia (VT)
|
Participants With PVCs
Participants with Premature Ventricular Contractions (PVCS)
|
|---|---|---|
|
Total Number of Intramural Needle Ablations
|
11.2 ablations
Standard Deviation 9.0
|
—
|
SECONDARY outcome
Timeframe: at 6 monthsOutcome measures
| Measure |
Participants With VT
n=46 Participants
Participants with Ventricular Tachycardia (VT)
|
Participants With PVCs
Participants with Premature Ventricular Contractions (PVCS)
|
|---|---|---|
|
All-cause Mortality
|
0 Participants
|
—
|
Adverse Events
Intramural Needle Ablation
Serious events: 15 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intramural Needle Ablation
n=52 participants at risk
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
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure with hypoxia
|
1.9%
1/52 • 6 months
|
|
Nervous system disorders
Acute Stroke
|
1.9%
1/52 • 6 months
|
|
Cardiac disorders
Chest pain with recurrent VT
|
1.9%
1/52 • 6 months
|
|
Cardiac disorders
CHF
|
5.8%
3/52 • 6 months
|
|
Cardiac disorders
Complete Heart Block
|
1.9%
1/52 • 6 months
|
|
Cardiac disorders
Hypervolemia with right ventricular failure and increased right sided pressures
|
1.9%
1/52 • 6 months
|
|
General disorders
Hypotension
|
1.9%
1/52 • 6 months
|
|
Cardiac disorders
LAA thrombus
|
1.9%
1/52 • 6 months
|
|
Nervous system disorders
Metabolic encephalopathy with hyperammonemia
|
1.9%
1/52 • 6 months
|
|
Cardiac disorders
Pericardial effusion
|
1.9%
1/52 • 6 months
|
|
Cardiac disorders
Pericardial effusion with hypotension
|
1.9%
1/52 • 6 months
|
|
General disorders
Repeated falls
|
1.9%
1/52 • 6 months
|
|
Vascular disorders
Right Femoral artery dissection
|
3.8%
2/52 • 6 months
|
|
Psychiatric disorders
Suicidal ideation
|
1.9%
1/52 • 6 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.9%
1/52 • 6 months
|
|
General disorders
Vasovagal syncope
|
1.9%
1/52 • 6 months
|
|
Cardiac disorders
Ventricular fibrillation
|
1.9%
1/52 • 6 months
|
Other adverse events
| Measure |
Intramural Needle Ablation
n=52 participants at risk
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
|
|---|---|
|
Cardiac disorders
Apical thrombus
|
1.9%
1/52 • 6 months
|
|
Vascular disorders
Bleed from groin site
|
1.9%
1/52 • 6 months
|
|
Cardiac disorders
Cardiac Sarcoidosis
|
1.9%
1/52 • 6 months
|
|
Cardiac disorders
Chest pain
|
1.9%
1/52 • 6 months
|
|
Cardiac disorders
Complete Heart Block
|
1.9%
1/52 • 6 months
|
|
Infections and infestations
Fever
|
1.9%
1/52 • 6 months
|
|
Gastrointestinal disorders
Gastrointestinal bleed
|
1.9%
1/52 • 6 months
|
|
Vascular disorders
Hematoma
|
1.9%
1/52 • 6 months
|
|
Renal and urinary disorders
Hematuria with UTI and urinary retention
|
1.9%
1/52 • 6 months
|
|
General disorders
Hypotension
|
3.8%
2/52 • 6 months
|
|
Cardiac disorders
Left bundle branch block
|
1.9%
1/52 • 6 months
|
|
Vascular disorders
Left femoral artery dissection
|
1.9%
1/52 • 6 months
|
|
Vascular disorders
Left groin hematoma
|
1.9%
1/52 • 6 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.9%
1/52 • 6 months
|
|
General disorders
Orthostatic hypotension with lightheadedness and tremors
|
1.9%
1/52 • 6 months
|
|
Renal and urinary disorders
Paraphimosis
|
1.9%
1/52 • 6 months
|
|
Cardiac disorders
Pericardial effusion
|
1.9%
1/52 • 6 months
|
|
Cardiac disorders
Pericarditis
|
1.9%
1/52 • 6 months
|
|
Renal and urinary disorders
Renal failure
|
1.9%
1/52 • 6 months
|
|
Renal and urinary disorders
UTI
|
1.9%
1/52 • 6 months
|
|
Cardiac disorders
Ventricular tachycardia with intermittent chest pain and dyspnea
|
1.9%
1/52 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place