Resync-AF (Rate vs Rhythm Control in AF Patients With CRT-D)

This study is being done to find out if controlling rate or controlling rhythm is better for heart failure patients who also have AF. Patients with AF who are receiving a CRT-D device and AV node ablation as part of their clinical care will be followed for one year. One group will have their heart rate controlled by the ICD and AVN ablation alone and the second group will be treated with the ICD, AVN ablation and standard medical therapies to restore the heart's normal rhythm. The study doctors will compare the information collected from all of the subjects in this study to see if treating rate or treating rhythm is better in patients with heart failure and AF, resulting in a better quality of life.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UPMC Cardiovascular Institute

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Having persistent AF, defined as AF that does not self terminate for at least 24 consecutive hours.
In AF upon entry into the operating room for CRT-D implantation and AV node ablation.
Being on a stable dosage of an ACE inhibitor or ARB for at least 1 month preceding implant
Being on a Beta-blocker for at least 3 months preceding implant and a stable dosage within 1 month of implant
Not taking or able to be taken off all type I/III antiarrhythmic medications.
Taking Coumadin so as to maintain an INR of between 2 and 3.
A Class I or IIa ICD indication
NYHA Class III/IV within 1 month of baseline
Intrinsic QRS duration ≥ 130 ms within 1 month prior to baseline
Left ventricular ejection fraction ≤ 35% (method per physician discretion) within 1 month prior to baseline
Left ventricular end diastolic dimension (LVEDD) ≥ 55 mm (method per physician discretion) within 1 months prior to baseline
Willing to provide written informed consent
Are expected to survive for 6 month of study participation
Able to tolerate an urgent thoracotomy
Able to tolerate < 1 mg dexamethasone sodium phosphate (steroid)

Exclusion criteria

Having self-terminating or interminable AF
Having unstable angina, or having experienced an acute myocardial infarction (MI) or received coronary artery revascularization (CABG) or coronary angioplasty (PTCA) within the past 1 month
Post-heart transplant (patients on heart transplant list for the first time are not excluded)
Having mechanical right heart valve
Having an existing CRT or atrial therapy device(s)
Being enrolled in any concurrent drug and/or device study which would confound the results of this trial
Having primary valvular disease and indicated for valve repair or replacement
Having a previous AV node ablation
Being on a Type I or Type III anti-arrhythmic medication for the treatment of ventricular tachyarrhythmias
Women who are pregnant or with child bearing potential and who are not on a reliable form of birth control

Treatment and study plan

rate control via CRT-D and AVN ablation

Other

rate control

rhythm control via pharmacologic, electrical or ablative therapies

Other

rhythm control

Primary outcomes

AF burden

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Important dates

Study start: 2006
Primary completion: 2015
Study completion: 2015
First posted: Nov 3, 2010
Registry last updated: Mar 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed