LEAF - Low Energy In Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Low Energy in Atrial Fibrillation AF Phase IV Study in AT/AF Population Atrial Arrhythmias Prevention and Reduction With Low Energy Atrial Antitachycardia Pacemaker

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00157781
• Other study ID #: 124
• Secondary ID: CP00/63 (CCPPRB
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2005
• Last updated: January 29, 2018
• Start date: August 2000
• Est. completion date: November 2003

Study information

• Verified date: January 2018
• Source: Medtronic Bakken Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to demonstrate the efficiency on AT / AF prevention and termination of a new algorithm contained in the Medtronic AT500 Antitachycardia device in patients with conventional pacemaker indications.

Description:

Aim. More than 30% of patients (pts) implanted with a pacemaker are known to have atrial tachyarrhythmias (AT) despite medical treatment and about 20% of pts experience AT prior to implant. The Medtronic AT500TM is a new DDDRP pacemaker with extended memory and features designed for preventing and terminating AT. The objective of this European multi-center prospective crossover and randomized study is to evaluate efficacy of this device for decreasing AT burden, improving QOL and reducing symptoms and costs. Method. 243 pts are implanted with the AT500TM and followed at 1, 7 and 13 months after implant. All patients are selected for a dual chamber pacemaker indication plus at least two episodes of AT in the last 12 months. One month after implantation patients are randomized either to a six month therapy phase (activation of preventive and ATP pacing) or a six month observation phase (No AT prevention nor Therapy). Crossover (CO) takes place at seven months after implant and the endpoint is reached at 13 months. Symptom checklist and QOL questionnaires are completed by pts at enrollment and after the two randomization periods. At each follow-up, a Save to Disk (STD) of device-stored AT episodes is performed and hospitalization, visits and/or other examinations are reported for future cost evaluation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: November 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ACC/AHA Class I or II indication for dual chamber pacing and two symptomatic atrial fibrillation or flutter episodes in the three months prior to implant as well as ECG documentation of at least one episode in the prior year.

Exclusion Criteria:

• Patients with permanent/persistent AF, an indication for an implantable cardioverter defibrillator or class IV heart failure.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Tachyarrhythmia
• Tachycardia

Intervention

Device:
• Medtronic AT500

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center	Medtronic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstrate that AT 500 algorithms decrease AF Burden
Secondary	Characterize the efficiency of prevention and termination algorithms on the Quality of Life of patients
Secondary	Characterize the correlation between symptoms and stored EGM's
Secondary	Determine the total number of AF/AT episodes and observe the decrement of their occurrence frequency due to prevention algorithms.
Secondary	Determine the number of Hospitalization, physician visits…: economical analyze
Secondary	Analyze the episode onset mechanism