NCT00289289

Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out if specialized programs in the AT500 and EnRhythm pacemakers will reduce the number of irregular heartbeat in the upper chamber of the heart and reduce symptoms (such as shortness of breath, dizziness, and others).

Detailed description

The purpose of the study was to confirm the AT500 intervention pacing effectiveness data previously seen in the ASPECT clinical trial and to gather additional data to understand the effectiveness of the intervention pacing features. Specifically, the goal of the trial is to demonstrate a reduction in frequency in symptomatic atrial tachycardia/atrial fibrillation recurrence with the intervention pacing features in patients with a pacing indication and a history of atrial tachyarrhythmias with atrial pacing leads located in the region of Bachmann's Bundle.

Conditions

• Atrial Fibrillation
• Tachycardia, Supraventricular
• Arrhythmia
• Bradycardia

Interventions

Type	Name	Description
DEVICE	Intervention Pacing Features	Intervention pacing features (atrial rate stabilization algorithm, atrial preference pacing algorithm, post mode switch overdrive pacing algorithm) in the pacemaker.

Timeline

• Start date: 2004-02-01
• Primary completion: 2010-11-01
• Completion: 2011-07-01
• First posted: 2006-02-09
• Last updated: 2012-08-08
• Results posted: 2012-08-08

Locations

38 sites across 2 countries: United States, Canada