Clinical trial NCT00289289: Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT)
Official title: Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Tachycardia, Supraventricular
Arrhythmia
Bradycardia
Keywords: Atrial Fibrillation
Atrial Tachyarrhythmia
Arrhythmia
Bradycardia
Cardiac Pacemaker
IPG Indication
Pacing
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2006-02-09
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Symptomatic Atrial Tachycardia/Atrial Fibrillation Episodes Per Subject Per Month
timeFrame: 6-months (per Intervention)
Secondary outcomes:
measure: Evaluate Subject Symptoms With the Atrial Fibrillation (AF) Symptom Checklist
timeFrame: 6 months (per Intervention)
measure: Time to First Cardioversion (Changing an Abnormal Heart Rhythm Into a Normal One by Using Either Medication or Electrical Shock)
timeFrame: 6 months (per Intervention)
measure: Atrial Tachycardia/Atrial Fibrillation (AT/AF) Burden
timeFrame: 6 months (per Intervention)
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Rancho Mirage
country: United States
state: California
city: San Diego
country: United States
state: California
city: Yuba City
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Jacksonville
country: United States
state: Florida
city: Lakeland
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Decatur
country: United States
state: Illinois
city: Urbana
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Cedar Rapids
country: United States
state: Iowa
city: Louisville
country: United States
state: Kentucky
city: Owensboro
country: United States
state: Kentucky
city: Takoma Park
country: United States
state: Maryland
city: Springfield
country: United States
state: Massachusetts
city: Minneapolis
country: United States
state: Minnesota
city: Clifton
country: United States
state: New Jersey
city: Morristown
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Mineola
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Hershey
country: United States
state: Pennsylvania
city: Spartanburg
country: United States
state: South Carolina
city: Amarillo
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Corpus Christi
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Burlington
country: United States
state: Vermont
city: Richmond
country: United States
state: Virginia
city: Morgantown
country: United States
state: West Virginia
city: Edmonton
country: Canada
state: Alberta
city: Hamilton
country: Canada
state: Ontario
city: Kingston
country: Canada
state: Ontario
city: Sherbrooke
country: Canada
state: Quebec
Study officials:
affiliation: Medtronic
name: RESPECT Team
role: STUDY_CHAIR
References: