DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Ischemic Ventricular Tachyarrhythmias

Information source: Central Finland Hospital District
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Myocardial Infarction; Ventricular Tachyarrhythmia

Intervention: Radiofrequency catheter ablation (Procedure); Antiarrhythmic drug therapy (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Central Finland Hospital District

Official(s) and/or principal investigator(s):
Pekka Raatikainen, MD PhD, Principal Investigator, Affiliation: Keski-Suomen sairaanhoitopiiri

Overall contact:
Pekka Raatikainen, MD, PhD, Phone: +358503169001, Email: pekka.raatikainen@ksshp.fi

Summary

The study evaluates whether catheter based radiofrequency ablation is superior to optimized antiarrhythmic medical therapy in preventing ventricular tachyarrhythmia relapses in patients with ischemic heart disease and implantable cardioverter defibrillator.

Clinical Details

Official title: Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Ischemic Ventricular Tachyarrhythmias. A Prospective, Randomized Multicentre Study.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of ventricular tachycardia (VT) or ventricular fibrillation (VF) episodes

Secondary outcome:

All cause mortality

Cardiovascular mortality

Time to first hospitalization and number of hospital days

Comparative cost-effectiveness of the therapies

Quality of life measured By SF-36 and EQ5D questionnaires

Patient related outcome measured by the PHQ-9, GAD-7, ICDC-8 and EXPECT-ICD questionnaires

Number of appropriate ICD therapies and sustained VT/VF episodes

Number of non-sustained VT episodes

Number of electrical storm episodes

Time to first VT/VF

Time to reablation

Number of inappropriate ICD therapies

Number of atrial fibrillation and other supraventricular arrhythmia episodes

Detailed description: The study is designed to evaluate whether catheter based radiofrequency ablation is superior to optimized antiarrhythmic medical therapy in preventing ventricular tachyarrhythmia relapses among patients with prior myocardial infarction and implantable cardioverter defibrillator (ICD). The patients have not been using using chronic antiarrhythmic medication. Primary end point is number of ICD therapies (defibrillations, cardioversions and antitachycardia pacing) and otherwise documented sustained ventricular tachycardia (duration more than 30 s or hemodynamically unstable ) or ventricular fibrillation episodes during 12 months follow-up period. Secondary end points include mortality, hospitalization for cardiac reason, health economics, quality of life and several ICD and arrhythmia related issues. Total length of the follow-up is at least two years.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients 18-80 years of age with prior myocardial infarction and ICD (single chamber,

dual chamber ICD or ICD with biventricular pacing capability (CRT-D)) for primary or secondary prevention of sudden cardiac death (SCD), who have had at least two documented episodes of sustained VT or VF and no chronic amiodarone treatment for ventricular tachyarrhythmias Exclusion Criteria:

- Age less than 18 years or more than 80 years

- Non-ischemic cardiomyopathy

- Ongoing chronic treatment of ventricular tachyarrhythmias with amiodarone,

intolerance/contraindication to all class III antiarrhythmic drugs (i. e., intolerance/contraindication to one class III agents is not excluding the patient if another one can be used)

- Contraindication to endocardial catheter ablation (e. g., intracavitary thrombi,

contraindication to perioperative anticoagulation)

- Previous VT/VF ablation

- Open heart surgery within 3 months

- Prosthetic heart valve

- Planned revascularization (PCI or CABG)

- Surgery for structural heart disease or heart transplantation

- Pregnancy or planned pregnancy within the follow-up period

- Secondary cause for VT/VF (e. g., acute myocardial infarction)

- Patient does not want to participate

- Life expectancy less than 12 months

Locations and Contacts

Pekka Raatikainen, MD, PhD, Phone: +358503169001, Email: pekka.raatikainen@ksshp.fi

Central Finland Central Hospital, Jyväskylä, Finland
Additional Information

Starting date: December 2014
Last updated: November 28, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017