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Optimal Pacing Rate for Cardiac Resynchronization Therapy

ConditionAtrial Fibrillation, Persistent
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorMedstar Health Research Institute

About this trial

This is a prospective, randomized crossover study. The objective of the study is to determine if a pacing rate of 80 beats per minute (bpm) improves exercise tolerance during the 6-minute walk test. The investigators will randomly assign half of the participants to a starting rate of 60 bpm and then switch them to a rate of 80 bpm for 3 months, and vice versa.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

History of persistent or permanent atrial fibrillation

Implantation of CRT or conduction system pacing in prior 3 months to 5 years of study start

History of intrinsic AVN block or have undergone AVN ablation in prior 3 months to 5 years of study start

Disqualifiers

LVEF <50%

Wide QRS (greater than 150ms)

Isolated RV pacing

Severe valvular disease

Trial design

Design model

Crossover

Treatments tested in this trial

  • Pacing rate of 80 bpm

    Device

    Pacing rate of 80 bpm

  • Pacing rate of 60 bpm

    Device

    Pacing rate of 60 bpm

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: 60 bpm, then 80 bpmExperimental treatment 2 interventions
Group B: 80 bpm, then 60 bpmExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Exercise tolerance as measured by the Six-Minute Walk Test

Exercise tolerance as measured by the Six-Minute Walk Test

Time frame
3 months

Secondary outcomes

1

Quality of life as measured by the Kansas City Cardiomyopathy Questionnaire

Quality of life as measured by the Kansas City Cardiomyopathy Questionnaire

Time frame
3 months
2

Function as measured by the International Physical Activity Questionnaire

Function as measured by the International Physical Activity Questionnaire

Time frame
3 months
3

Change in B-type natriuretic peptide (BNP)

Change in B-type natriuretic peptide (BNP)

Time frame
3 months
4

Change in creatinine

Change in creatinine

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medstar Health Research Institute

Lead sponsor

Medtronic

Collaborator

Source ClinicalTrials.gov
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