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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
Medtronic Bakken Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 13, 2009
Last Updated
February 14, 2017
Sponsor
Medtronic Bakken Research Center
Collaborators
Medtronic
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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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