Trial Outcomes & Findings for Bipolar Ventricular Tachycardia (VT) Study (NCT NCT02374476)
NCT ID: NCT02374476
Last Updated: 2022-11-01
Results Overview
Freedom from recurrent VT at 6 months, defined as sustained ventricular tachycardia lasting longer than 30 seconds and identified due to clinical symptoms or during device interrogation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
145 participants
Primary outcome timeframe
6 months
Results posted on
2022-11-01
Participant Flow
Participant milestones
| Measure |
All Patients
All patients who met inclusion criteria and have VT not terminable with unipolar ablation underwent bipolar ablation.
|
Bipolar Ablation
Participants who underwent bipolar ablation after unipolar ablation unsuccessful
|
Registry
Participants in Patient Registry after standard radiofrequency (VT) unipolar radiofrequency (RF) ablation was successful
|
|---|---|---|---|
|
VT Induced Ablation
STARTED
|
145
|
0
|
0
|
|
VT Induced Ablation
COMPLETED
|
109
|
0
|
0
|
|
VT Induced Ablation
NOT COMPLETED
|
36
|
0
|
0
|
|
Arm Assignment
STARTED
|
0
|
49
|
60
|
|
Arm Assignment
COMPLETED
|
0
|
49
|
59
|
|
Arm Assignment
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
All Patients
All patients who met inclusion criteria and have VT not terminable with unipolar ablation underwent bipolar ablation.
|
Bipolar Ablation
Participants who underwent bipolar ablation after unipolar ablation unsuccessful
|
Registry
Participants in Patient Registry after standard radiofrequency (VT) unipolar radiofrequency (RF) ablation was successful
|
|---|---|---|---|
|
VT Induced Ablation
Screening Failures
|
36
|
0
|
0
|
|
Arm Assignment
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Bipolar Ablation
n=49 Participants
Participants who underwent bipolar ablation after unipolar ablation unsuccessful
|
Patient Registry
n=60 Participants
Participants in Patient Registry after standard radiofrequency (VT) unipolar radiofrequency (RF) ablation was successful
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.88 years
STANDARD_DEVIATION 11.29 • n=49 Participants
|
63.1 years
STANDARD_DEVIATION 11.31 • n=60 Participants
|
63 years
STANDARD_DEVIATION 11.24 • n=109 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=49 Participants
|
6 Participants
n=60 Participants
|
8 Participants
n=109 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=49 Participants
|
54 Participants
n=60 Participants
|
101 Participants
n=109 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 6 monthsFreedom from recurrent VT at 6 months, defined as sustained ventricular tachycardia lasting longer than 30 seconds and identified due to clinical symptoms or during device interrogation.
Outcome measures
| Measure |
Bipolar Ablation
n=49 Participants
Participants who underwent bipolar ablation after unipolar ablation unsuccessful
|
Patient Registry
n=60 Participants
Participants in Patient Registry after standard radiofrequency (VT) unipolar radiofrequency (RF) ablation was successful
|
|---|---|---|
|
Number of Participants Achieving Freedom From Recurrent Ventricular Tachycardia (VT)
|
16 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: 6 monthsTotal number of procedural complications which includes death, stroke, MI, heart failure, conduction abnormalities, pericardial effusion requiring drainage, hematoma, pseudoaneurysm
Outcome measures
| Measure |
Bipolar Ablation
n=49 Participants
Participants who underwent bipolar ablation after unipolar ablation unsuccessful
|
Patient Registry
n=60 Participants
Participants in Patient Registry after standard radiofrequency (VT) unipolar radiofrequency (RF) ablation was successful
|
|---|---|---|
|
Number of Procedural Complications
|
31 events
|
19 events
|
SECONDARY outcome
Timeframe: 6 monthsNumber of participants to indicate incidence of the induction of any sustained arrhythmia post-ablation, with a duration \> 15 seconds of monomorphic VT (MMVT). Post ablation inducibility is measured via program stimulation.
Outcome measures
| Measure |
Bipolar Ablation
n=49 Participants
Participants who underwent bipolar ablation after unipolar ablation unsuccessful
|
Patient Registry
n=60 Participants
Participants in Patient Registry after standard radiofrequency (VT) unipolar radiofrequency (RF) ablation was successful
|
|---|---|---|
|
Number of Participants With Post-ablation Inducibility of VT
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: through termination, up to 60 secondsWhen bipolar ablation is performed during ongoing Ventricular Tachycardia (VT), the time to termination is the amount of ablation time that was necessary to cause VT to stop (terminate)
Outcome measures
| Measure |
Bipolar Ablation
n=49 Participants
Participants who underwent bipolar ablation after unipolar ablation unsuccessful
|
Patient Registry
Participants in Patient Registry after standard radiofrequency (VT) unipolar radiofrequency (RF) ablation was successful
|
|---|---|---|
|
Time to Arrhythmia Termination for the Bipolar Group Only
|
14.33 seconds
Standard Deviation 10.29
|
—
|
SECONDARY outcome
Timeframe: average of 345 minutesDuration of bipolar ablation is the total procedure time
Outcome measures
| Measure |
Bipolar Ablation
n=49 Participants
Participants who underwent bipolar ablation after unipolar ablation unsuccessful
|
Patient Registry
n=60 Participants
Participants in Patient Registry after standard radiofrequency (VT) unipolar radiofrequency (RF) ablation was successful
|
|---|---|---|
|
Total Duration of Bipolar Ablation
|
342.22 minutes
Standard Deviation 133.82
|
317.33 minutes
Standard Deviation 128.98
|
SECONDARY outcome
Timeframe: 6 monthsNumber of participant from all cause mortality
Outcome measures
| Measure |
Bipolar Ablation
n=49 Participants
Participants who underwent bipolar ablation after unipolar ablation unsuccessful
|
Patient Registry
n=60 Participants
Participants in Patient Registry after standard radiofrequency (VT) unipolar radiofrequency (RF) ablation was successful
|
|---|---|---|
|
Number of of Participants With Mortality
|
9 Participants
|
5 Participants
|
Adverse Events
Bipolar Ablation
Serious events: 26 serious events
Other events: 14 other events
Deaths: 9 deaths
Patient Registry
Serious events: 25 serious events
Other events: 8 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Bipolar Ablation
n=49 participants at risk
Bipolar Ablation: Patients underwent bipolar ablation when unipolar ablation unsuccessful
|
Patient Registry
n=60 participants at risk
Participants in Patient Registry after standard radiofrequency (VT) unipolar radiofrequency (RF) ablation was successful
|
|---|---|---|
|
Cardiac disorders
Cardiac Tamponade
|
8.2%
4/49 • 6 months
|
0.00%
0/60 • 6 months
|
|
Cardiac disorders
Recurrent Ventricular Tachycardia
|
18.4%
9/49 • 6 months
|
16.7%
10/60 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism Pneumonia
|
6.1%
3/49 • 6 months
|
0.00%
0/60 • 6 months
|
|
Cardiac disorders
Pericardial Effusion due to myocardial performation
|
2.0%
1/49 • 6 months
|
0.00%
0/60 • 6 months
|
|
Cardiac disorders
Left Ventricular Thrombus
|
2.0%
1/49 • 6 months
|
1.7%
1/60 • 6 months
|
|
Cardiac disorders
Pericardial Effusion
|
12.2%
6/49 • 6 months
|
1.7%
1/60 • 6 months
|
|
Cardiac disorders
Hemorrhagic Shock
|
4.1%
2/49 • 6 months
|
0.00%
0/60 • 6 months
|
|
Cardiac disorders
New Incessant Ventricular Tachycardia
|
4.1%
2/49 • 6 months
|
0.00%
0/60 • 6 months
|
|
Cardiac disorders
Pericarditis
|
4.1%
2/49 • 6 months
|
0.00%
0/60 • 6 months
|
|
Cardiac disorders
Hemothorax
|
2.0%
1/49 • 6 months
|
0.00%
0/60 • 6 months
|
|
Cardiac disorders
Cardiac Arrest/anoxic brain injury
|
2.0%
1/49 • 6 months
|
0.00%
0/60 • 6 months
|
|
Cardiac disorders
Implantable Cardioverter Defibrillator Shock
|
2.0%
1/49 • 6 months
|
0.00%
0/60 • 6 months
|
|
General disorders
Chest pain/Fever
|
4.1%
2/49 • 6 months
|
0.00%
0/60 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.0%
1/49 • 6 months
|
0.00%
0/60 • 6 months
|
|
General disorders
Lower Extremity Swelling/Weight Gain
|
2.0%
1/49 • 6 months
|
0.00%
0/60 • 6 months
|
|
Gastrointestinal disorders
Gastrointestinal Hemorrhage
|
4.1%
2/49 • 6 months
|
0.00%
0/60 • 6 months
|
|
Cardiac disorders
Hemodynamic decompensation/cardiac arrest post procedure
|
2.0%
1/49 • 6 months
|
0.00%
0/60 • 6 months
|
|
Cardiac disorders
Total Artificial Heart Implantation/Severe atherosclerotic Coronary Artery Disease
|
2.0%
1/49 • 6 months
|
0.00%
0/60 • 6 months
|
|
Cardiac disorders
Acute MI
|
2.0%
1/49 • 6 months
|
0.00%
0/60 • 6 months
|
|
Cardiac disorders
Recurrent Ventricular Tachycardia/LVAD Implantation
|
2.0%
1/49 • 6 months
|
0.00%
0/60 • 6 months
|
|
Cardiac disorders
Aortic Regurgitation requiring valve replacement
|
2.0%
1/49 • 6 months
|
0.00%
0/60 • 6 months
|
|
Cardiac disorders
Generator change
|
4.1%
2/49 • 6 months
|
0.00%
0/60 • 6 months
|
|
Cardiac disorders
Lead revision due to increased defibrillation threhold
|
2.0%
1/49 • 6 months
|
0.00%
0/60 • 6 months
|
|
Cardiac disorders
Heart Transplant
|
2.0%
1/49 • 6 months
|
0.00%
0/60 • 6 months
|
|
Vascular disorders
Hemoperitoneum
|
4.1%
2/49 • 6 months
|
0.00%
0/60 • 6 months
|
|
Cardiac disorders
Cardiogenic Shock/Septic Shock
|
2.0%
1/49 • 6 months
|
0.00%
0/60 • 6 months
|
|
Gastrointestinal disorders
Gastrointestinal Bleed/Melena
|
2.0%
1/49 • 6 months
|
0.00%
0/60 • 6 months
|
|
Cardiac disorders
Pulseless Electrical Activity
|
2.0%
1/49 • 6 months
|
0.00%
0/60 • 6 months
|
|
General disorders
Oopharyngeal swallow dysfunction
|
2.0%
1/49 • 6 months
|
0.00%
0/60 • 6 months
|
|
Cardiac disorders
Hypercarbia and Fluid Overload
|
2.0%
1/49 • 6 months
|
0.00%
0/60 • 6 months
|
|
Cardiac disorders
Congestive Heart Failure
|
2.0%
1/49 • 6 months
|
5.0%
3/60 • 6 months
|
|
Injury, poisoning and procedural complications
Right Femoral Artery Pseudoaneurysm
|
2.0%
1/49 • 6 months
|
0.00%
0/60 • 6 months
|
|
Cardiac disorders
Fluid Overload
|
2.0%
1/49 • 6 months
|
1.7%
1/60 • 6 months
|
|
Cardiac disorders
Right Ventricular Failure
|
2.0%
1/49 • 6 months
|
0.00%
0/60 • 6 months
|
|
Infections and infestations
Infection
|
0.00%
0/49 • 6 months
|
1.7%
1/60 • 6 months
|
|
Nervous system disorders
Hypoxic Brain Injury
|
2.0%
1/49 • 6 months
|
0.00%
0/60 • 6 months
|
|
Cardiac disorders
recurrent ventricular tachycardia with biventricular failure
|
0.00%
0/49 • 6 months
|
1.7%
1/60 • 6 months
|
|
Renal and urinary disorders
renal failure
|
0.00%
0/49 • 6 months
|
1.7%
1/60 • 6 months
|
|
Cardiac disorders
new incessant ventricular tachycardia with redo ablation
|
0.00%
0/49 • 6 months
|
1.7%
1/60 • 6 months
|
|
General disorders
back pain/diaphoresis/hematuria
|
0.00%
0/49 • 6 months
|
1.7%
1/60 • 6 months
|
|
Cardiac disorders
pre-syncope and elevated cardiact enzymes
|
0.00%
0/49 • 6 months
|
1.7%
1/60 • 6 months
|
|
Cardiac disorders
recurrent ventricular tachycardia/end stage heart failure
|
0.00%
0/49 • 6 months
|
1.7%
1/60 • 6 months
|
|
Renal and urinary disorders
pneumoperitoneum, renal failure (intolerable to dialysis)
|
0.00%
0/49 • 6 months
|
1.7%
1/60 • 6 months
|
|
Cardiac disorders
congestive heart failure/fluid overload
|
0.00%
0/49 • 6 months
|
1.7%
1/60 • 6 months
|
|
Nervous system disorders
cerebrovascular accident/encephalopahty
|
0.00%
0/49 • 6 months
|
1.7%
1/60 • 6 months
|
|
Infections and infestations
orchitis
|
0.00%
0/49 • 6 months
|
1.7%
1/60 • 6 months
|
|
General disorders
food poisoining
|
0.00%
0/49 • 6 months
|
1.7%
1/60 • 6 months
|
|
Cardiac disorders
cardiogenic shock
|
0.00%
0/49 • 6 months
|
1.7%
1/60 • 6 months
|
|
Injury, poisoning and procedural complications
left femoral pseudoaneurysm
|
0.00%
0/49 • 6 months
|
1.7%
1/60 • 6 months
|
|
Nervous system disorders
slurred speech
|
0.00%
0/49 • 6 months
|
1.7%
1/60 • 6 months
|
|
Vascular disorders
right subclavian/axillary thrombosis
|
0.00%
0/49 • 6 months
|
1.7%
1/60 • 6 months
|
|
Injury, poisoning and procedural complications
oropharynx bleeding
|
0.00%
0/49 • 6 months
|
1.7%
1/60 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
hypoxic respiratory failure
|
0.00%
0/49 • 6 months
|
1.7%
1/60 • 6 months
|
|
Gastrointestinal disorders
gastrointestinal bleed
|
0.00%
0/49 • 6 months
|
1.7%
1/60 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
hemo-pneumothorax
|
0.00%
0/49 • 6 months
|
1.7%
1/60 • 6 months
|
|
Cardiac disorders
lead modification
|
0.00%
0/49 • 6 months
|
1.7%
1/60 • 6 months
|
Other adverse events
| Measure |
Bipolar Ablation
n=49 participants at risk
Bipolar Ablation: Patients underwent bipolar ablation when unipolar ablation unsuccessful
|
Patient Registry
n=60 participants at risk
Participants in Patient Registry after standard radiofrequency (VT) unipolar radiofrequency (RF) ablation was successful
|
|---|---|---|
|
Cardiac disorders
Complete Heart Block
|
12.2%
6/49 • 6 months
|
3.3%
2/60 • 6 months
|
|
Renal and urinary disorders
Acute Kidney Injury
|
4.1%
2/49 • 6 months
|
5.0%
3/60 • 6 months
|
|
Cardiac disorders
Volume Overload
|
6.1%
3/49 • 6 months
|
3.3%
2/60 • 6 months
|
|
Vascular disorders
Groin Hematoma
|
2.0%
1/49 • 6 months
|
1.7%
1/60 • 6 months
|
|
Infections and infestations
Urinary Tract Infection
|
2.0%
1/49 • 6 months
|
0.00%
0/60 • 6 months
|
|
Vascular disorders
Post Ablation Hypotension
|
2.0%
1/49 • 6 months
|
0.00%
0/60 • 6 months
|
Additional Information
Dr. Srinivas R Dukkipati
Icahn School of Medicine at Mount Sinai
Phone: (212) 241-7114
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60