NCT01557842: ASPIRE

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

Terminated Phase 4 Results posted Last updated 8 June 2017

What this trial tests

Phase 4 trial testing Drug Treatment in Ventricular Tachycardia in 15 participants. Terminated before completion.

Timeline

1 June 2012

Primary endpoint
19 March 2014

19 March 2014

Quick facts

Lead sponsor	Biosense Webster, Inc.
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	1 June 2012
Primary completion	19 March 2014
Estimated completion	19 March 2014
Sites	23 locations across United States

Drugs / interventions tested

• Drug Treatment — full drug profile →
• Catheter Ablation

Conditions studied

• Ventricular Tachycardia — all drugs for Ventricular Tachycardia →
• Ischemic — all drugs for Ischemic →

Sponsor

Biosense Webster, Inc. — full company profile →

Who can join

18 and older, any sex, with Ventricular Tachycardia or Ischemic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Subjects Who Had Hospitalization for Ventricular Tachycardia (VT) Related Causes/Events Primary · From one month to 2 years follow up

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

Group	Value	95% CI
Catheter Ablation Group	0
Drug Treatment Group	16.67

Cardiac-related Death Primary · 2 years follow up

Subjects with cardiac-related death

Group	Value	95% CI
Catheter Ablation Group	0
Drug Treatment Group	0

Adverse events — posted to ClinicalTrials.gov

Time frame: During the 3-year follow-up after the ablation procedure.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Catheter Ablation Group

Serious: 3/9 (33%)

Deaths: —

Drug Treatment Group

Serious: 4/6 (67%)

Deaths: —

Serious adverse events (8 terms)

Reaction	System	Catheter Ablation Group	Drug Treatment Group
Hypotension	Vascular disorders	—	—
Heart Failure	Cardiac disorders	—	—
Congestive Heart Failure	Cardiac disorders	—	—
Ventricular Tachycardia	Cardiac disorders	—	—
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	—	—
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	—	—
Deep Venous Thrombosis Distal	Vascular disorders	—	—
Adenocarcinoma Lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—

Other adverse events (14 terms — click to expand)

Reaction	System	Catheter Ablation Group	Drug Treatment Group
Heart Failure	Cardiac disorders	—	—
Ventricular Fibrillation	Cardiac disorders	—	—
Ventricular Tachycardia	Cardiac disorders	—	—
Ventricular Tachyarrhythmia	Cardiac disorders	—	—
Pericarditis	Cardiac disorders	—	—
Intracardiac Thrombus	Cardiac disorders	—	—
Chronotropic Incompetence	Cardiac disorders	—	—
Pneumothorax	Respiratory, thoracic and mediastinal disorders	—	—
Neurological Symptom	Nervous system disorders	—	—
Medical Device Removal	Surgical and medical procedures	—	—
Hypertension	Vascular disorders	—	—
Deep Venous Thrombosis NOS	Vascular disorders	—	—
Pseudomonas Infection	Infections and infestations	—	—
Obstructive Sleep Apnea Syndrome	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: Hypotension, Heart Failure, Congestive Heart Failure, Ventricular Tachycardia, Respiratory Failure, Pleural Effusion, Deep Venous Thrombosis Distal, Adenocarcinoma Lung.

Data from ClinicalTrials.gov NCT01557842 adverse events section.

Sponsor's own description

The purpose of this study is to determine if early ablation (i.e., ablation of ventricular tachycardia in patients with infrequent VT episodes) is more effective than medical therapy alone for the treatment of ischemic ventricular tachycardia in patients with Implantable Cardioverter Defibrillators (ICDs) who continue to have episodes of ventricular tachycardia despite drug therapy.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. 2019 HRS/EHRA/APHRS/LAHRS expert consensus statement on catheter ablation of ventricular arrhythmias.
   Cronin EM, Bogun FM, Maury P, Peichl P, et al · · 2019 · cited 278× · PMID 31075787 · DOI 10.1093/europace/euz132
2. 2019 HRS/EHRA/APHRS/LAHRS expert consensus statement on catheter ablation of ventricular arrhythmias.
   Cronin EM, Bogun FM, Maury P, Peichl P, et al · · 2020 · cited 232× · PMID 31085023 · DOI 10.1016/j.hrthm.2019.03.002
3. 2019 HRS/EHRA/APHRS/LAHRS expert consensus statement on catheter ablation of ventricular arrhythmias.
   Cronin EM, Bogun FM, Maury P, Peichl P, et al · · 2019 · cited 32× · PMID 31293696 · DOI 10.1002/joa3.12185
4. 2019 HRS/EHRA/APHRS/LAHRS expert consensus statement on catheter ablation of ventricular arrhythmias.
   Cronin EM, Bogun FM, Maury P, Peichl P, et al · · 2020 · cited 24× · PMID 31984466 · DOI 10.1007/s10840-019-00663-3