APART: Prevention and Automatic Therapy of Atrial Arrhythmias in Patients With Paroxysmal Supraventricular Tachycardias

Medtronic Cardiac Rhythm and Heart Failure156 enrolled

Overview

The goal of APART is the assessment of the therapeutic and preventive stimulation algorithms of the Medtronic AT500 and following devices in patients with atrial tachyarrhythmias and an indication for cardiac pacing according to the German guidelines. Medication is controlled throughout the study with a beta-blocker as the only antiarrhythmic drug.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

156

Conditions

Tachyarrhythmia

Interventions

Activation of preventive and therapeutic algorithms for treatment of AFDEVICE

Algorithms in At 500 or Enrhyhtm for prevention and termination of Atrial Fibrillation

AF Prevention and Therapy Algorithms OnDEVICE

Activation of AF-prevention and termination algorithms in AT 500 or EnRhyhtm

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Indication for cardiac pacing according to the German guidelines * Documented (electrocardiogram; ECG) atrial arrhythmia during the last three months before enrollment * Willingness to terminate antiarrhythmic drugs until the first recurrence of an atrial arrhythmia * Sinus rhythm during 24 hours before implant of the device Exclusion Criteria: * Ejection fraction below 40% * Mechanic prosthesis of the tricuspid valve * Indication to implantable cardioverter defibrillator (ICD)-implantation * Pregnancy

Locations (6)

Segeberger Kliniken

Bad Segeberg, Germany

Kath. Krankenhausgemeinschaft GmbH, Philippusstift Essen

Essen, Germany

Krankenhaus Marienhof

Koblenz, Germany

Klinikum der Stadt Ludwigshafen

Ludwigshafen, Germany

Outcomes

Primary Outcomes

Incidence of symptomatic and/or persistent re-occurrences of atrial arrhythmias

Time frame: 2 years

Time to first re-occurrence of first symptomatic or persistent atrial arrhythmia

Time frame: 2 years

Secondary Outcomes

Atrial fibrillation (AF)-burden

Time frame: 2 years

Time interval between persistent episodes during the follow-up period

Time frame: 2 years

Reduction of the total amount of tachyarrhythmias stored in the event counter of the implanted device

Time frame: 2 years

Quality of life

Time frame: 2 years

Necessity and date of a specific antiarrhythmic therapy and/or prescription of antiarrhythmic drugs class I and II

Time frame: 2 years

Evaluation of possible atrial proarrhythmic effects of the termination algorithms

Time frame: 2 years

Cost-efficiency

Time frame: 2 years

Incidence in different pacing modes [AAI, DDD(R)]

Time frame: 2 years

Data from ClinicalTrials.gov

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