AVJ Ablation Followed by Resynchronization Therapy in Pat... | NCT00547794

Studies
AVJ Ablation Followed by Resynchronization Therapy in Patients With CHF and AF

NCT00547794

Sponsor

Abbott Medical Devices

Status

Terminated

Last Update Posted

Feb 4, 2019Actual

Enrollment

14Actual

Phase

Not provided

Conditions

Atrial Fibrillation
Congestive Heart Failure

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulty in patient enrollment

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Aug 2010Actual

Completion Date

Nov 2010Actual

First Submitted Date

Oct 19, 2007

First Submission Date that Met QC Criteria

Oct 22, 2007

First Posted Date

Oct 23, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2019

Last Update Posted Date

Feb 4, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to determine if the combination of AVJ ablation followed by BiV pacing significantly improves functional status and exercise capacity compared to pharmacologic rate control in patients with chronic AF and depressed ejection fraction, regardless of rate or QRS duration.

Detailed Description

This is a prospective, randomized, double blinded, multicenter study
Patients meeting all the enrollment criteria are screened at enrollment and randomized to Group 1 (Pharmacological therapy + Single Chamber ICD) or Group 2 (AVJ Ablation + CRT-D)
Screened patients are implanted with a FDA approved SJM ICD/CRT-D with compatible lead system
Patients are followed at 1, 3, 6 and 12 months post implant
Total # of centers - 20 centers
Sample size - 180 patients

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Exercise duration		12 month post implant

Secondary Outcomes

Measure	Description	Time Frame
Quality of Life (QOL) via Minnesota Living With Heart Failure (MLWH) questionnaire		12 month post implant
NYHA Class Progression		12 month post implant
LVEF

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Symptomatic permanent AF
Class I or II indication for ICD
LVEF ≤ 35% within 6 months
NYHA class II or III with a history of CHF
Maximal tolerated drug therapy for CHF and rate control with a stable regimen for ≥ 30 days
Ability to independently comprehend and complete a QoL questionnaire
Ability to give informed consent for study participation and willingness and ability to comply with prescribed follow-up tests and scheduled evaluations

Exclusion Criteria:

Paroxysmal or persistent AF
Class I indication for pacing (including AVJ ablation for poor rate control)
Ability to walk ≥ 450 meters in 6 minutes
Musculoskeletal disorders that prohibit the completion of a 450 meters walk
NYHA class I or IV at the time of enrollment
A contraindication to taking Coumadin therapy
History of myocardial infarction, percutanous coronary intervention, or CABG in the past 30 days
History of mitral valve surgery
Prior attempts for cardiac resynchronization therapy
The presence of an existing coronary sinus lead or epicardial lead
Life expectancy < 1year
Age < 18 yrs
Current participation in other clinical studies except registry trials
Use of calcium channel blockers
Pregnancy
Inability to give informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient with history of permanent AF and CHF

Sampling Method

Probability Sample

Name	Affiliation	Role
Mohamed Hamdan, MD	University of Utah Health Sciences	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Utah		Salt Lake City	Utah	84108	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17038140	Background	Hamdan MH, Freedman RA, Gilbert EM, Dimarco JP, Ellenbogen KA, Page RL. Atrioventricular junction ablation followed by resynchronization therapy in patients with congestive heart failure and atrial fibrillation (AVERT-AF) study design. Pacing Clin Electrophysiol. 2006 Oct;29(10):1081-8. doi: 10.1111/j.1540-8159.2006.00502.x.

Label	Type	Description	Intervention Names
CRT-D + AVJ Ablation
Single-Chamber ICD + Pharmacological Therapy

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

ID	Term
D001281	Atrial Fibrillation
D006333	Heart Failure