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Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT)

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Medtronic

Status

Completed

Conditions

Tachycardia, Supraventricular
Bradycardia
Arrhythmia
Atrial Fibrillation

Treatments

Device: Intervention Pacing Features

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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).

Full 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.

Enrollment

400 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subjects with fast and/or slow heartbeats who are in need of dual chamber pacing (pacing in both the atria and ventricles) as determined by their doctor.
  • Subjects who have a history of occasional fast heartbeats originating from the upper heart chambers.
  • Subjects who have experienced at least two symptomatic episodes of fast heartbeats three months prior to enrollment.
  • Subjects that are expected to stay on the same heart medications during the length study.

Exclusion criteria

  • Subjects who have permanent (chronic) or persistent (not self-terminating) atrial fibrillation (fast heartbeats originating from the upper heart chambers).
  • Subjects who have atrial fibrillation due to a reversible cause, i.e. electrolyte imbalance.
  • Subjects who are current or immediate implantable cardioverter defibrillator (ICD) recipients.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

400 participants in 3 patient groups

On-Off
Active Comparator group
Description:
Subjects have intervention pacing features turned On according to randomization assignment in the first crossover period then Off in the second period.
Treatment:
Device: Intervention Pacing Features
Off-On
Active Comparator group
Description:
Subjects have intervention pacing features turned Off according to the randomization assignment for the first crossover period and then On in the second period.
Treatment:
Device: Intervention Pacing Features
Non-randomized
No Intervention group
Description:
Subjects that did not have device recorded episodes of atrial tachycardia/atrial fibrillation during the 3 month observation period post-implant did not qualify for randomization but were continued to be followed in the study. There were no programming requirements and symptom activations were not collected.

Trial contacts and locations

38

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Data sourced from clinicaltrials.gov

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