Trial Outcomes & Findings for Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia (NCT NCT01791543)

NCT ID: NCT01791543

Last Updated: 2023-02-01

Results Overview

Freedom from hospitalization for recurrent Ventricular Tachycardia during the 6 months following ablation for VT.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 115 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2023-02-01

Participant Flow

Patients referred for ablation of ventricular arrhythmias who met the entry criteria were enrolled at Vanderbilt University Medical Center or Brigham and Women's Hospital from 9/19/2016 to 8/26/2020.

115 unique subjects signed consent and were enrolled; 6 were consented twice (121 enrollments): 1 had no needle ablation when standard ablation was successful at both procedures; 3 had needle ablation at the first but not the second procedure; 2 had needle ablation twice and outcomes are reported for their first procedure only. Of the 115, 39 exited before treatment (standard ablation successful in 30, VT not inducible in 7, other reasons in 2). Thus, 76 unique participants started the study.

Participant milestones

Measure	Intramural Needle Catheter Ablation Patients meeting the entry criteria and consented for participation in the study
Overall Study STARTED	76
Overall Study COMPLETED	74
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Intramural Needle Catheter Ablation Patients meeting the entry criteria and consented for participation in the study
Overall Study Lost to Follow-up	1
Overall Study Adverse Event	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Intramural Needle Catheter Ablation n=76 Participants Patients Treated With Intramural Needle Ablation
Age, Continuous	65 years n=76 Participants
Sex: Female, Male Female	12 Participants n=76 Participants
Sex: Female, Male Male	64 Participants n=76 Participants
Region of Enrollment United States	76 participants n=76 Participants
Left Ventricular Ejection Fraction (LVEF)	0.38 ejection fraction n=76 Participants
Coronary Artery Disease	35 Participants n=76 Participants
Nonischemic heart diseases	59 Participants n=76 Participants
History of heart failure	41 Participants n=76 Participants
Number of prior failed ablation procedures (median, range)	2 prior procedures n=76 Participants
Failed amiodarone	61 Participants n=76 Participants
Failed mexiletine	36 Participants n=76 Participants
Implanted Defibrillator	60 Participants n=76 Participants
Ablation for ventricular tachycardia (VT)	56 Participants n=76 Participants
Ablation for premature ventricular contractions (PVCs)/Nonsustained VT	20 Participants n=76 Participants

PRIMARY outcome

Timeframe: 6 months

Population: This outcome is analyzed only for the 54 patients whose targeted arrhythmia was ventricular tachycardia.

Freedom from hospitalization for recurrent Ventricular Tachycardia during the 6 months following ablation for VT.

Outcome measures

Measure	Intramural Needle Catheter Ablation n=54 Participants Ablation of Ventricular Tachycardia with Intramural Needle Ablation Catheter Intramural Needle Ablation Catheter
Number of Subjects Without Hospitalization for Ventricular Tachycardia (VT) During 6 Months	38 Participants

PRIMARY outcome

Timeframe: 30 days

Absence of serious adverse events that are potentially device related and occur within 30 days of the ablation procedure

Outcome measures

Measure	Intramural Needle Catheter Ablation n=76 Participants Ablation of Ventricular Tachycardia with Intramural Needle Ablation Catheter Intramural Needle Ablation Catheter
Number of Participants With No Serious Adverse Events	63 Participants

PRIMARY outcome

Timeframe: 6 months

Population: This outcome is analyzed only for the 20 patients in whom PVCs/Nonsustained VT was the targeted arrhythmia for study entry.

Number of subjects who had ablation for nonsustained arrhythmias with ventricular dysfunction who had a decrease in ambient ventricular arrhythmia to < 5000 ventricular beats daily.

Outcome measures

Measure	Intramural Needle Catheter Ablation n=20 Participants Ablation of Ventricular Tachycardia with Intramural Needle Ablation Catheter Intramural Needle Ablation Catheter
Number of Subjects Ablated for Nonsustained Arrhythmias Who Had a Reduction to Less Than 5000 Arrhythmia Beats Daily	12 Participants

SECONDARY outcome

Timeframe: Baseline to end of the ablation procedure (approximately 5 hours)

Population: This secondary efficacy endpoint was not assessed in 16 patients in whom VT induction was not attempted because in the judgment of the investigator it imposed unwarranted risk of hemodynamic deterioration. Acute success for PVC/nonsustained VT ablation was abolishing the targeted PVC..

Defined as termination of at least one clinical or presumptive clinical monomorphic VT by Radiofrequency ablation and/or rendering that VT no longer inducible or abolition of a targeted nonsustained arrhythmia.

Outcome measures

Measure	Intramural Needle Catheter Ablation n=60 Participants Ablation of Ventricular Tachycardia with Intramural Needle Ablation Catheter Intramural Needle Ablation Catheter
Number of Subjects With Acute Abolition of at Least One Clinical Inducible Ventricular Tachycardia or Targeted Nonsustained Arrhythmia	51 Participants

Adverse Events

Intramural Needle Catheter Ablation

Serious events: 13 serious events

Other events: 5 other events

Deaths: 5 deaths

Serious adverse events

Measure	Intramural Needle Catheter Ablation n=76 participants at risk Patients Treated With Intramural Needle Ablation
Cardiac disorders Pericardial Effusion	2.6% 2/76 • Number of events 2 • 6 months
Cardiac disorders Pulmonary Embolism	2.6% 2/76 • Number of events 2 • 6 months
Vascular disorders Retroperitoneal Hematoma	2.6% 2/76 • Number of events 2 • 6 months
Renal and urinary disorders urinary tract infection	1.3% 1/76 • Number of events 1 • 6 months
Cardiac disorders ventricular fibrillation	1.3% 1/76 • Number of events 1 • 6 months
General disorders Allergic reaction	1.3% 1/76 • Number of events 1 • 6 months
Cardiac disorders Pericarditis	1.3% 1/76 • Number of events 1 • 6 months
Respiratory, thoracic and mediastinal disorders Pulmonary hemorrhage	1.3% 1/76 • Number of events 1 • 6 months
Cardiac disorders AV block	2.6% 2/76 • Number of events 2 • 6 months
Gastrointestinal disorders GI bleed	1.3% 1/76 • Number of events 1 • 6 months
Cardiac disorders Heart Failure Exacerbation	1.3% 1/76 • Number of events 1 • 6 months
Gastrointestinal disorders Intraperitoneal bleeding	1.3% 1/76 • Number of events 1 • 6 months
Cardiac disorders atrial fibrillation with rapid response	1.3% 1/76 • Number of events 1 • 6 months

Other adverse events

Measure	Intramural Needle Catheter Ablation n=76 participants at risk Patients Treated With Intramural Needle Ablation
Vascular disorders Femoral hematoma	6.6% 5/76 • Number of events 5 • 6 months

Additional Information

William G Stevenson, MD

Vanderbilt University Medical Center

Phone: 1-615-322-2318

Email: william.g.stevenson@vumc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place