PAF-HEFT (Permanent Atrial Fibrillation in Heart Failure Trial) (PAF-HEFT)
Primary Purpose
Atrial Fibrillation, Heart Failure
Status
Terminated
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Ablation
Rate Control
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Heart Failure
Eligibility Criteria
Inclusion Criteria:
- LVEF <35%
- QRS time ≥150ms LBB
- NYHA classification ≥ NYHA III
- permanent (> 6 months) Atrial Fibrillation
- sinus rhythm (control group)
- Condition after Implantation of a Medtronic CRT device
- written informed consent
Exclusion Criteria:
- exchange of the current CRT device
- mitral incompetence (2. degree)
- no compliance
- participation in another study
- pregnancy
- patients with AV node
- patients after heart transplant or those who are on the transplant list
Sites / Locations
- Professor Dr. med. Christian Perings
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
AV ablation
Rate control
Sinus rhythm
Arm Description
Rate control by drugs
Outcomes
Primary Outcome Measures
End systolic left ventricular diameter
Secondary Outcome Measures
NYHA-Class, Echo-parameters, ECG-parameters, VO2 max,6 minutes hallwalk-test
Full Information
NCT ID
NCT00839566
First Posted
January 13, 2009
Last Updated
February 14, 2017
Sponsor
Medtronic Bakken Research Center
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT00839566
Brief Title
PAF-HEFT (Permanent Atrial Fibrillation in Heart Failure Trial)
Acronym
PAF-HEFT
Official Title
Permanent Atrial Fibrillation in Heart Failure Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
Number of eligible patients too small.
Study Start Date
November 2008 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Bakken Research Center
Collaborators
Medtronic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Examination of CRT efficacy in patients with progressive heart failure and atrial fibrillation at the same time
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Heart Failure
Keywords
Atrial Fibrillation, Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AV ablation
Arm Type
Experimental
Arm Title
Rate control
Arm Type
Active Comparator
Arm Description
Rate control by drugs
Arm Title
Sinus rhythm
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Ablation
Intervention Description
AV-node ablation
Intervention Type
Other
Intervention Name(s)
Rate Control
Intervention Description
Rate control by drug
Primary Outcome Measure Information:
Title
End systolic left ventricular diameter
Time Frame
12 months
Secondary Outcome Measure Information:
Title
NYHA-Class, Echo-parameters, ECG-parameters, VO2 max,6 minutes hallwalk-test
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
LVEF <35%
QRS time ≥150ms LBB
NYHA classification ≥ NYHA III
permanent (> 6 months) Atrial Fibrillation
sinus rhythm (control group)
Condition after Implantation of a Medtronic CRT device
written informed consent
Exclusion Criteria:
exchange of the current CRT device
mitral incompetence (2. degree)
no compliance
participation in another study
pregnancy
patients with AV node
patients after heart transplant or those who are on the transplant list
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Perings, MD
Organizational Affiliation
marien Hospital Luenen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Professor Dr. med. Christian Perings
City
Luenen
ZIP/Postal Code
44534
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Not applicable as NO is selected above for 'Plan to share IPD?"
Learn more about this trial
PAF-HEFT (Permanent Atrial Fibrillation in Heart Failure Trial)
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