Initial Management of Patients Receiving a Single Shock (IMPRESS)

NCT03531502 | Terminated DMC

• 1 other identifier: IMPRESS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to determine the optimal treatment for patients who receive a single shock from their implantable cardioverter defibrillator (ICD). All participants in this study will be fitted with a special electrode vest to detect the origin of heart rhythm abnormalities and then they will undergo a procedure called Non-Invasive Programmed Stimulation (NIPS). This procedure involves sedating a participants with anesthesia and then using the participant's own ICD to try to stimulate the heart to go into ventricular tachycardia. If this procedure is unable to induce the participant into ventricular tachycardia, then the participant will just be managed with usual care and will not be placed on any additional medications and will not undergo an ablation. However, if the NIPS induces the ventricular tachycardia, the electrode vest will be used to determine the origin of the abnormal heart rhythm inside the heart. After a successful NIPS procedure, the participants will be randomly assigned to either be placed on medication therapy or undergo catheter ablation. The outcomes from all three groups will be compared and the researchers hope to better understand which participants are most likely to benefit from watchful waiting versus medication versus catheter ablation.

Conditions

Ventricular Tachycardia

Keywords

tachycardia; defibrillator; arrythmia

Outcome Measures

Primary Outcomes (1)

• ICD Shocks

  Number of recurrent ICD shocks

  12 months

Secondary Outcomes (7)

• Total Mortality

  12 months

• Hospitalizations

  12 months

• ATP Therapy as recorded by ICD

  12 months

• Non-sustained VT

  12 months

• Initiation of antiarrythmic medication

  12 months

Study Arms (3)

Standard medical therapy

ACTIVE COMPARATOR

Patients who have a positive NIPS study and are randomized to the medical therapy arm will either be initiated on antiarrhythmic therapy or will have their antiarrhythmic therapy intensified. All medication therapy is considered usual standard therapy.

Other: Standard Medical Therapy; Procedure: Non-Invasive Programmed Stimulation (NIPS)

Ventricular Tachycardia Ablation

EXPERIMENTAL

Patients who have a positive NIPS study and are randomized to the ablation arm will undergo ventricular tachycardia ablation procedure guided by CardioInsight.

Procedure: Ventricular Tachycardia Ablation; Procedure: Non-Invasive Programmed Stimulation (NIPS)

Negative NIPS/Non-intervention

OTHER

Patients who had a negative NIPS study will not be assigned to a treatment group and will be followed according to standard of care.

Procedure: Non-Invasive Programmed Stimulation (NIPS)

Interventions

Ventricular Tachycardia Ablation PROCEDURE

Ventricular Tachycardia Ablation

Ventricular Tachycardia Ablation

Standard Medical Therapy OTHER

For the antiarrhythmic naïve patients, the attending physician may initiate therapy with sotalol or amiodarone. For patients already on therapy with sotalol or amiodarone, the attending physician may choose to either increase the dosage/ frequency of these medications and/or add mexiletine to the regimen. Other alterations to medical therapy, such as adjusting the dose of beta-blockers, calcium-channel blockers, anti-hypertensive, diuretic or anti-anginal medications may be performed at the discretion of the attending physician.

Standard medical therapy

Non-Invasive Programmed Stimulation (NIPS) PROCEDURE

All patients will receive this procedure in attempt to induce ventricular tachycardia. The outcome of this procedure determines if a patient will be randomized.

Negative NIPS/Non-intervention; Standard medical therapy; Ventricular Tachycardia Ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old, both males and females
• Single or dual chamber ICD or BiVentricular ICD in situ
• Ischemic or non-ischemic cardiomyopathy
• Receive a single shock from their ICD for monomorphic ventricular tachycardia

You may not qualify if:

• ICD shock for polymorphic VT/VF or inappropriate shock
• Previous ventricular tachycardia ablation within 1 year
• NYHA Class IV heart failure or current inotrope therapy
• Ventricular tachycardia storm
• Listed for heart transplant or LVAD
• Pregnant as determined by urine pregnancy test prior to NIPS

Sponsors & Collaborators

• Saint Luke's Health System: lead
• Medtronic: collaborator

Study Sites (1)

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Related Publications (4)

• Reddy VY, Reynolds MR, Neuzil P, Richardson AW, Taborsky M, Jongnarangsin K, Kralovec S, Sediva L, Ruskin JN, Josephson ME. Prophylactic catheter ablation for the prevention of defibrillator therapy. N Engl J Med. 2007 Dec 27;357(26):2657-65. doi: 10.1056/NEJMoa065457.

  PMID: 18160685 RESULT

• Sapp JL, Wells GA, Parkash R, Stevenson WG, Blier L, Sarrazin JF, Thibault B, Rivard L, Gula L, Leong-Sit P, Essebag V, Nery PB, Tung SK, Raymond JM, Sterns LD, Veenhuyzen GD, Healey JS, Redfearn D, Roux JF, Tang AS. Ventricular Tachycardia Ablation versus Escalation of Antiarrhythmic Drugs. N Engl J Med. 2016 Jul 14;375(2):111-21. doi: 10.1056/NEJMoa1513614. Epub 2016 May 5.

  PMID: 27149033 RESULT

• Frankel DS, Mountantonakis SE, Zado ES, Anter E, Bala R, Cooper JM, Deo R, Dixit S, Epstein AE, Garcia FC, Gerstenfeld EP, Hutchinson MD, Lin D, Patel VV, Riley MP, Robinson MR, Tzou WS, Verdino RJ, Callans DJ, Marchlinski FE. Noninvasive programmed ventricular stimulation early after ventricular tachycardia ablation to predict risk of late recurrence. J Am Coll Cardiol. 2012 Apr 24;59(17):1529-35. doi: 10.1016/j.jacc.2012.01.026.

  PMID: 22516442 RESULT

• Kheiri B, Barbarawi M, Zayed Y, Hicks M, Osman M, Rashdan L, Kyi HH, Bachuwa G, Hassan M, Stecker EC, Nazer B, Bhatt DL. Antiarrhythmic Drugs or Catheter Ablation in the Management of Ventricular Tachyarrhythmias in Patients With Implantable Cardioverter-Defibrillators: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Circ Arrhythm Electrophysiol. 2019 Nov;12(11):e007600. doi: 10.1161/CIRCEP.119.007600. Epub 2019 Nov 8.

  PMID: 31698933 DERIVED

MeSH Terms

Conditions

Tachycardia, Ventricular; Tachycardia; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sanjaya Gupta, MD

  Saint Luke's Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, randomized, controlled

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: May 21, 2018
• Study Start: April 9, 2018
• Primary Completion: April 4, 2023
• Study Completion: April 4, 2023
• Last Updated: April 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)