Atrial FibrillationNCT00289289

Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT)

A study testing Intervention Pacing Features in people with Atrial Fibrillation and Tachycardia, Supraventricular, run by Medtronic Cardiac Rhythm and Heart Failure at 38 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Any age
Conditions the study is for: Atrial Fibrillation, Tachycardia, Supraventricular, Arrhythmia
What is being tested?: Intervention Pacing Features
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 400 participants
Where: 38 sitesin 2 countries
Study dates: Feb 2004to Jul 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

38 sites in 2 countries.

Country

City, postcode or hospital

38 sites in 2 countries

United States34 sites

Study site
Albuquerque, New Mexico
Study site
Amarillo, Texas
Study site
Austin, Texas
Study site
Burlington, Vermont
Study site
Cedar Rapids, Iowa
Study site
Charlotte, North Carolina
Study site
Chicago, Illinois
Study site
Cleveland, Ohio
Study site
Clifton, New Jersey
Study site
Colorado Springs, Colorado
Study site
Columbus, Ohio
Study site
Corpus Christi, Texas
Study site
Decatur, Illinois
Study site
Fort Worth, Texas
Study site
Hershey, Pennsylvania
Study site
Indianapolis, Indiana
Study site
Jacksonville, Florida
Study site
Lakeland, Florida
Study site
Little Rock, Arkansas
Study site
Louisville, Kentucky
Study site
Mineola, New York
Study site
Minneapolis, Minnesota
Study site
Morgantown, West Virginia
Study site
Morristown, New Jersey
Study site
Owensboro, Kentucky
Study site
Rancho Mirage, California
Study site
Richmond, Virginia
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Salt Lake City, Utah
Study site
San Diego, California
Study site
Spartanburg, South Carolina
Study site
Springfield, Massachusetts
Study site
Takoma Park, Maryland
Study site
Urbana, Illinois
Study site
Yuba City, California

Other trials in United States

Canada4 sites

Study site
Edmonton, Alberta
Study site
Hamilton, Ontario
Study site
Kingston, Ontario
Study site
Sherbrooke, Quebec

Other trials in Canada

About this study

Read the 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
Being tested: Intervention Pacing Features
Keywords: Atrial Fibrillation, Atrial Tachyarrhythmia, Arrhythmia, Bradycardia, Cardiac Pacemaker, IPG Indication, Pacing
Medical subject headings: Atrial Fibrillation, Tachycardia, Supraventricular, Arrhythmias, Cardiac, Bradycardia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intervention Pacing FeaturesDevice
Intervention pacing features (atrial rate stabilization algorithm, atrial preference pacing algorithm, post mode switch overdrive pacing algorithm) in the pacemaker.

Study groups in NCT00289289
Study group	Role	What they receive
On-Off	Active comparator	Subjects have intervention pacing features turned On according to randomization assignment in the first crossover period then Off in the second period. Receives: Device: Intervention Pacing Features
Off-On	Active comparator	Subjects have intervention pacing features turned Off according to the randomization assignment for the first crossover period and then On in the second period. Receives: Device: Intervention Pacing Features
Non-randomized	No intervention	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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of Symptomatic Atrial Tachycardia/Atrial Fibrillation Episodes Per Subject Per Month
The frequency of symptomatic atrial tachycardia/atrial fibrillation (AT/AF) episodes as measured by the Patient Assistant and retrieved from save-to-disk information. For each subject and programming period (3-9 month period and 9-15 month period), the rate of symptomatic AT/AF episodes was computed by summing the total number of Patient Assistant activations during device recorded AT/AF episodes divided by months of device follow-up in each study period. Within each subject, the ON minus OFF difference in rate of symptomatic AT/AF was computed
Measured: 6-months (per Intervention)

Secondary outcomes (3)

Evaluate Subject Symptoms With the Atrial Fibrillation (AF) Symptom Checklist
The AF symptom checklist (SCL) is a 16 item questionnaire measuring the frequency of 16 arrhythmia related symptoms such as tiredness/lack of energy, heart fluttering/skipping, heart racing, lightheadedness, etc. Symptom frequency is rated as never (scored as 0), rarely (scored as 1), sometimes (scored as 2), often (scored as 3), and always (scored as 4). Scores are summed across each subject and timepoint and range from 0 (no symptoms) to 64 (always symptoms). For each subject the 9 month and 15 months scores were summed respectively and ON minus OFF differences computed.
Measured: 6 months (per Intervention)
Time to First Cardioversion (Changing an Abnormal Heart Rhythm Into a Normal One by Using Either Medication or Electrical Shock)
The dates of cardioversions attempted for atrial fibrillation (AF) since the previous study visit were collected at the 3, 9, and 15 month follow-up visits. For each randomized subject, the months to first attempted cardioversion during each randomized study period (3-9 months and 9-15 months) was determined. A repeated measures Cox proportional hazards model was used to compare the attempted cardioversion rate during periods of time where the pacing features were programmed ON versus OFF.
Measured: 6 months (per Intervention)
Atrial Tachycardia/Atrial Fibrillation (AT/AF) Burden
AT/AF burden is defined as the sum of the duration of all atrial arrhythmias as recorded by the device divided by the device follow-up time during the programming period expressed as hours of atrial arrhythmia per day.
Measured: 6 months (per Intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2004Jul 2011

First posted9 Feb 2006 (estimated)
Study startFeb 2004
Primary completionNov 2010
Study completionJul 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 400 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00289289
Sponsor's protocol ID: 217
Status last verified: Jun 2012
First submitted: 7 Feb 2006
Last updated: 8 Aug 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT)
ClinicalTrials.gov ID: NCT00289289
Acronym / sponsor ID: 217
Conditions: Atrial Fibrillation, Tachycardia, Supraventricular, Arrhythmia, Bradycardia
Keywords: Atrial Fibrillation, Atrial Tachyarrhythmia, Arrhythmia, Bradycardia, Cardiac Pacemaker, IPG Indication, Pacing
Study type: Interventional
Recruitment status: Completed
Enrolment: 400 participants (actual)
Lead sponsor: Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
Study start: Feb 2004
Primary completion: Nov 2010 (actual)
Study completion: Jul 2011 (actual)
First posted: 9 Feb 2006 (estimated)
Results: Posted 8 Aug 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
On-Off	Active comparator	Device: Intervention Pacing FeaturesSubjects have intervention pacing features turned On according to randomization assignment in the first crossover period then Off in the second period.
Off-On	Active comparator	Device: Intervention Pacing FeaturesSubjects have intervention pacing features turned Off according to the randomization assignment for the first crossover period and then On in the second period.
Non-randomized	No intervention	–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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intervention Pacing FeaturesIntervention pacing features (atrial rate stabilization algorithm, atrial preference pacing algorithm, post mode switch overdrive pacing algorithm) in the pacemaker.	Device	Off-On, On-Off

Primary outcome

Rate of Symptomatic Atrial Tachycardia/Atrial Fibrillation Episodes Per Subject Per Month
Time frame: 6-months (per Intervention)
The frequency of symptomatic atrial tachycardia/atrial fibrillation (AT/AF) episodes as measured by the Patient Assistant and retrieved from save-to-disk information. For each subject and programming period (3-9 month period and 9-15 month period), the rate of symptomatic AT/AF episodes was computed by summing the total number of Patient Assistant activations during device recorded AT/AF episodes divided by months of device follow-up in each study period. Within each subject, the ON minus OFF difference in rate of symptomatic AT/AF was computed

3 secondary outcomes

Evaluate Subject Symptoms With the Atrial Fibrillation (AF) Symptom Checklist
Time frame: 6 months (per Intervention)
Time to First Cardioversion (Changing an Abnormal Heart Rhythm Into a Normal One by Using Either Medication or Electrical Shock)
Time frame: 6 months (per Intervention)
Atrial Tachycardia/Atrial Fibrillation (AT/AF) Burden
Time frame: 6 months (per Intervention)

Results and safety

Results posted to the registry on 8 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
On-Off	132	113
Off-On	124	114
Non-Randomized Group	144	95

Primary outcome: Rate of Symptomatic Atrial Tachycardia/Atrial Fibrillation Episodes Per Subject Per Month

Time frame: 6-months (per Intervention). Mean (Standard Deviation). Unit: Episodes per subject per month

Measure	Intervention Pacing Features Programmed ON n = 222	Intervention Pacing Features Programmed OFF n = 222
Value	2.0 (4.8)	1.8 (5.2)

Intervention Pacing Features Programmed ON vs Intervention Pacing Features Programmed OFF: Mean Difference (Final Values): 0.1, p = 0.629, t-test, 1 sided

Population analysed: Patient Assistant data which contained markers for symptomatic atrial tachycardia or atrial fibrillation episodes obtained from save-to-disk data was required from both randomized follow-up periods (3-9 months and 9-15 months) for the subject to be included in the primary ITT analysis.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment through the 15-month study visit. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
On-Off	7 of 132 (5.3%)	0 of 0	Not reported
Off-On	8 of 124 (6.5%)	0 of 0	Not reported
Non-Randomized Group	4 of 144 (2.8%)	0 of 0	Not reported

Limitations and caveats (from the sponsor): The effect of ON programming was not consistent across randomized study period, violating a key assumption of the cross-over study design.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Atrial Fibrillation

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

RESPECT Team study chair

Medtronic

38 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Intervention Pacing Features in people with Atrial Fibrillation and Tachycardia, Supraventricular, run by Medtronic Cardiac Rhythm and Heart Failure at 38 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Symptomatic Atrial Tachycardia/Atrial Fibrillation Episodes Per Subject Per Month (time frame: 6-months (per Intervention)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00289289.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2012.