Pulmonary Vein Ablation Versus Amiodarone in the Elderly

NCT01276093 | Terminated DMC

• 1 other identifier: AF-10-023-ND-AB
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of the study is to demonstrate that in patients of 70 years or older with symptomatic paroxysmal atrial fibrillation (AF) pulmonary vein isolation (PVI) using RF ablation therapy is superior to medical treatment with amiodarone to prevent recurrence of AF.

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; PVI ablation; Elderly patients; Efficacy

Outcome Measures

Primary Outcomes (1)

• Recurrence of episodes of AF, atypical atrial flutter or left sided atrial tachycardia

  Until 1 year after post treatment blanking period

Secondary Outcomes (1)

• Composite end point of hospitalization, stroke, major bleeding and death

  Until last patient has been followed for 15 months after inclusion

Study Arms (2)

PVI ablation

EXPERIMENTAL

Pulmonary Vein Ablation

Procedure: PVI ablation

Amiodarone medical treatment

ACTIVE COMPARATOR

Amiodarone medical treatment

Drug: Amiodarone

Interventions

PVI ablation PROCEDURE

Pulmonary Vein Ablation using RF.

Also known as: Pulmonary Vein Isolation

PVI ablation

Amiodarone DRUG

Amiodarone tablets

Amiodarone medical treatment

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 65 years at moment of screening, able to sign informed consent.
• Documented paroxysmal AF in association with complaints in the last year, with at least 2 episodes of complaints attributed to AF in the previous 2 months.
• Paroxysmal AF documented with at least one ECG with sinus rhythm not after cardioversion in the last year.
• No prior use of amiodarone in the last 6 months and no usage longer than 4 weeks in total.

You may not qualify if:

• EF \< 35 % or description of "poor left ventricular function" on echocardiogram. Measurement should not be older than 6 months at moment of screening.
• Aortic, mitral, pulmonary or tricuspid valve regurgitation or stenosis, if graded severe (grade \>3)
• Acute illness: unstable angina, infectious disease.
• Primary structural or electrical heart disease: dilated cardiomyopathy, hypertrophic cardiomyopathy, Brugada syndrome, long QT syndrome.
• Reversible causes (thyroid dysfunction, uncontrolled hypertension, ischemia).
• Previous ablation.
• Contraindications for amiodarone; liver dysfunction (serum alanine aminotransferase \>2.5 times upper limit); thyroid dysfunction; chronic lung disease; baseline QTc \>460 ms. sinus node dysfunction (pause more than 3 seconds in sinus rhythm); second or third degree AV-block.
• Contraindications for anti-coagulation: prior life threatening hemorrhage under use of Vitamin K antagonists.
• Any myocardial infarction or PCI in previous 6 months.
• CABG in previous 6 months.
• Renal dysfunction: creatinine clearance \<45 ml/min
• Severe co-morbidity. Life expectancy less than 1 year.
• Thrombus in left atrium
• Untreatable allergy to contrast media

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (6)

Elkerliek Hospital

Helmond, North Brabant, Netherlands

Location

Maxima Medical Center

Veldhoven, North Brabant, 5504DB, Netherlands

Location

Haga Hospital

The Hague, South Holland, 2545 CH, Netherlands

Location

Onze Lieve Vrouwen Gasthuis

Amsterdam, 1091 AC, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, 5623 EJ, Netherlands

Location

Medisch Spectrum Twente

Enschede, 7513 ER, Netherlands

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Amiodarone

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Lukas Dekker, Dr

  Catharina Ziekenhuis Eindhoven

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 11, 2011
• First Posted: January 13, 2011
• Study Start: July 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: December 30, 2015

Record last verified: 2015-12

Locations

NL (6)