NCT01233648

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at below P25 for phase_4 atrial-fibrillation

Timeline
Completed

Started Jun 2006

Longer than P75 for phase_4 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2010

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

March 23, 2023

Status Verified

January 1, 2016

Enrollment Period

9.4 years

First QC Date

November 2, 2010

Last Update Submit

March 22, 2023

Conditions

Atrial Fibrillation

Keywords

heart failureCRT-D

Outcome Measures

Primary Outcomes (1)

  • AF burden

    1 year

Study Arms (2)

AF

ACTIVE COMPARATOR
Other: rate control via CRT-D and AVN ablation

SR

ACTIVE COMPARATOR
Other: rhythm control via pharmacologic, electrical or ablative therapies

Interventions

rate control via CRT-D and AVN ablationOTHER

rate control

AF
rhythm control via pharmacologic, electrical or ablative therapiesOTHER

rhythm control

SR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC Cardiovascular Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Atrial FibrillationHeart Failure

Interventions

Electricity

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electromagnetic PhenomenaMagnetic PhenomenaPhysical Phenomena

Study Officials

  • David S. Schwartzman, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2010

First Posted

November 3, 2010

Study Start

June 1, 2006

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

March 23, 2023

Record last verified: 2016-01

Locations

US(1)