Trial Outcomes & Findings for Early Ablation Therapy for the Treatment of Ischemic Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillators (NCT NCT01557842)

NCT ID: NCT01557842

Last Updated: 2017-06-08

Results Overview

The hospital admission date must occur after completing the 1-month follow-up visit for the event to be considered an effectiveness failure.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 15 participants
• Primary outcome timeframe: From one month to 2 years follow up
• Results posted on: 2017-06-08

Participant Flow

The first and the last subject were enrolled on July 9, 2012 and on January 30, 2014 respectively. All ASPIRE sites were notified that the study was terminated due to ongoing enrollment issues on March 10, 2014. A total of 21 US study sites were activated with 7 sites enrolling subjects. The last follow-up visit was completed on April 21, 2014.

Participant milestones

Measure	Catheter Ablation Group Subjects were randomly allocated to treatment in a 1:1 fashion. Subjects randomized to this arm were treated with ventricular tachycardia ablation using the NAVISTAR THERMOCOOL Catheter in conjunction with Class I and III anti-arrhythmic medical therapy. Determination of optimal medical therapy was at the discretion of the investigator.	Drug Treatment Group Subjects randomized to this arm were treated with Class I and III anti-arrhythmic medication alone. Determination of optimal medical therapy was at the discretion of the investigator.
Overall Study STARTED	9	6
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	9	6

Reasons for withdrawal

Measure	Catheter Ablation Group Subjects were randomly allocated to treatment in a 1:1 fashion. Subjects randomized to this arm were treated with ventricular tachycardia ablation using the NAVISTAR THERMOCOOL Catheter in conjunction with Class I and III anti-arrhythmic medical therapy. Determination of optimal medical therapy was at the discretion of the investigator.	Drug Treatment Group Subjects randomized to this arm were treated with Class I and III anti-arrhythmic medication alone. Determination of optimal medical therapy was at the discretion of the investigator.
Overall Study Lost to Follow-up	0	1
Overall Study Death	1	0
Overall Study Lack of Efficacy	0	1
Overall Study Not Meet Inclusion/Exclusion Criteria	3	0
Overall Study Study Terminated by Sponsor	3	4
Overall Study Not Ablated	2	0

Baseline Characteristics

Early Ablation Therapy for the Treatment of Ischemic Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillators

Baseline characteristics by cohort

Measure	Catheter Ablation Group n=9 Participants Subjects were randomly allocated to treatment in a 1:1 fashion. Subjects randomized to this arm were treated with ventricular tachycardia ablation using the NAVISTAR THERMOCOOL Catheter in conjunction with Class I and III anti-arrhythmic medical therapy. Determination of optimal medical therapy was at the discretion of the investigator.	Drug Treatment Group n=6 Participants Subjects randomized to this arm were treated with Class I and III anti-arrhythmic medication alone. Determination of optimal medical therapy was at the discretion of the investigator.	Total n=15 Participants Total of all reporting groups
Age, Continuous	68.0 years STANDARD_DEVIATION 14.4 • n=5 Participants	63.3 years STANDARD_DEVIATION 6.1 • n=7 Participants	66.1 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	6 participants n=7 Participants	15 participants n=5 Participants

PRIMARY outcome

Timeframe: From one month to 2 years follow up

Population: All enrolled subjects

The hospital admission date must occur after completing the 1-month follow-up visit for the event to be considered an effectiveness failure.

Outcome measures

Measure	Catheter Ablation Group n=9 Participants Subjects were randomly allocated to treatment in a 1:1 fashion. Subjects randomized to this arm were treated with ventricular tachycardia ablation using the NAVISTAR THERMOCOOL Catheter in conjunction with Class I and III anti-arrhythmic medical therapy. Determination of optimal medical therapy was at the discretion of the investigator.	Drug Treatment Group n=6 Participants Subjects randomized to this arm were treated with Class I and III anti-arrhythmic medication alone. Determination of optimal medical therapy was at the discretion of the investigator.
Percentage of Subjects Who Had Hospitalization for Ventricular Tachycardia (VT) Related Causes/Events	0 percentage of participants	16.67 percentage of participants

PRIMARY outcome

Timeframe: 2 years follow up

Population: All enrolled subjects

Subjects with cardiac-related death

Outcome measures

Measure	Catheter Ablation Group n=9 Participants Subjects were randomly allocated to treatment in a 1:1 fashion. Subjects randomized to this arm were treated with ventricular tachycardia ablation using the NAVISTAR THERMOCOOL Catheter in conjunction with Class I and III anti-arrhythmic medical therapy. Determination of optimal medical therapy was at the discretion of the investigator.	Drug Treatment Group n=6 Participants Subjects randomized to this arm were treated with Class I and III anti-arrhythmic medication alone. Determination of optimal medical therapy was at the discretion of the investigator.
Cardiac-related Death	0 percentage of participants	0 percentage of participants

Adverse Events

Catheter Ablation Group

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Drug Treatment Group

Serious events: 4 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Catheter Ablation Group n=9 participants at risk Subjects were randomly allocated to treatment in a 1:1 fashion. Subjects randomized to this arm were treated with ventricular tachycardia ablation using the NAVISTAR THERMOCOOL Catheter in conjunction with Class I and III anti-arrhythmic medical therapy. Determination of optimal medical therapy was at the discretion of the investigator.	Drug Treatment Group n=6 participants at risk Subjects randomized to this arm were treated with Class I and III anti-arrhythmic medication alone. Determination of optimal medical therapy was at the discretion of the investigator.
Cardiac disorders Heart Failure	0.00% 0/9 • During the 3-year follow-up after the ablation procedure.	16.7% 1/6 • Number of events 2 • During the 3-year follow-up after the ablation procedure.
Cardiac disorders Congestive Heart Failure	11.1% 1/9 • Number of events 1 • During the 3-year follow-up after the ablation procedure.	0.00% 0/6 • During the 3-year follow-up after the ablation procedure.
Cardiac disorders Ventricular Tachycardia	11.1% 1/9 • Number of events 1 • During the 3-year follow-up after the ablation procedure.	16.7% 1/6 • Number of events 1 • During the 3-year follow-up after the ablation procedure.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/9 • During the 3-year follow-up after the ablation procedure.	16.7% 1/6 • Number of events 1 • During the 3-year follow-up after the ablation procedure.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/9 • During the 3-year follow-up after the ablation procedure.	16.7% 1/6 • Number of events 1 • During the 3-year follow-up after the ablation procedure.
Vascular disorders Hypotension	0.00% 0/9 • During the 3-year follow-up after the ablation procedure.	33.3% 2/6 • Number of events 2 • During the 3-year follow-up after the ablation procedure.
Vascular disorders Deep Venous Thrombosis Distal	0.00% 0/9 • During the 3-year follow-up after the ablation procedure.	16.7% 1/6 • Number of events 1 • During the 3-year follow-up after the ablation procedure.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma Lung	11.1% 1/9 • Number of events 1 • During the 3-year follow-up after the ablation procedure.	0.00% 0/6 • During the 3-year follow-up after the ablation procedure.

Other adverse events

Measure	Catheter Ablation Group n=9 participants at risk Subjects were randomly allocated to treatment in a 1:1 fashion. Subjects randomized to this arm were treated with ventricular tachycardia ablation using the NAVISTAR THERMOCOOL Catheter in conjunction with Class I and III anti-arrhythmic medical therapy. Determination of optimal medical therapy was at the discretion of the investigator.	Drug Treatment Group n=6 participants at risk Subjects randomized to this arm were treated with Class I and III anti-arrhythmic medication alone. Determination of optimal medical therapy was at the discretion of the investigator.
Cardiac disorders Heart Failure	0.00% 0/9 • During the 3-year follow-up after the ablation procedure.	16.7% 1/6 • Number of events 1 • During the 3-year follow-up after the ablation procedure.
Cardiac disorders Ventricular Fibrillation	11.1% 1/9 • Number of events 3 • During the 3-year follow-up after the ablation procedure.	0.00% 0/6 • During the 3-year follow-up after the ablation procedure.
Cardiac disorders Ventricular Tachycardia	11.1% 1/9 • Number of events 1 • During the 3-year follow-up after the ablation procedure.	0.00% 0/6 • During the 3-year follow-up after the ablation procedure.
Cardiac disorders Ventricular Tachyarrhythmia	11.1% 1/9 • Number of events 1 • During the 3-year follow-up after the ablation procedure.	0.00% 0/6 • During the 3-year follow-up after the ablation procedure.
Cardiac disorders Pericarditis	11.1% 1/9 • Number of events 1 • During the 3-year follow-up after the ablation procedure.	0.00% 0/6 • During the 3-year follow-up after the ablation procedure.
Cardiac disorders Intracardiac Thrombus	0.00% 0/9 • During the 3-year follow-up after the ablation procedure.	16.7% 1/6 • Number of events 1 • During the 3-year follow-up after the ablation procedure.
Cardiac disorders Chronotropic Incompetence	0.00% 0/9 • During the 3-year follow-up after the ablation procedure.	16.7% 1/6 • Number of events 1 • During the 3-year follow-up after the ablation procedure.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/9 • During the 3-year follow-up after the ablation procedure.	16.7% 1/6 • Number of events 1 • During the 3-year follow-up after the ablation procedure.
Nervous system disorders Neurological Symptom	0.00% 0/9 • During the 3-year follow-up after the ablation procedure.	16.7% 1/6 • Number of events 1 • During the 3-year follow-up after the ablation procedure.
Surgical and medical procedures Medical Device Removal	0.00% 0/9 • During the 3-year follow-up after the ablation procedure.	16.7% 1/6 • Number of events 1 • During the 3-year follow-up after the ablation procedure.
Vascular disorders Hypertension	11.1% 1/9 • Number of events 1 • During the 3-year follow-up after the ablation procedure.	0.00% 0/6 • During the 3-year follow-up after the ablation procedure.
Vascular disorders Deep Venous Thrombosis NOS	0.00% 0/9 • During the 3-year follow-up after the ablation procedure.	16.7% 1/6 • Number of events 1 • During the 3-year follow-up after the ablation procedure.
Infections and infestations Pseudomonas Infection	0.00% 0/9 • During the 3-year follow-up after the ablation procedure.	16.7% 1/6 • Number of events 1 • During the 3-year follow-up after the ablation procedure.
Respiratory, thoracic and mediastinal disorders Obstructive Sleep Apnea Syndrome	11.1% 1/9 • Number of events 1 • During the 3-year follow-up after the ablation procedure.	0.00% 0/6 • During the 3-year follow-up after the ablation procedure.

Additional Information

Karen Cropper, Manager, Clinical Operations

Biosense Webster, Inc.

Phone: (800) 729-9010

Email: Kcropper@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee There IS an agreement between the Principal Investigator (PI)/Institution and the Sponsor (or its agents) that restricts the PI's rights to discuss, present or publish trial results after the trial is completed. Please contact Biosense Webster, Inc. for additional information.
• Publication restrictions are in place

Restriction type: OTHER