PAF-HEFT (Permanent Atrial Fibrillation in Heart Failure Trial)

Heart Failure Clinical Trial

— PAF-HEFT  

Official title:

Permanent Atrial Fibrillation in Heart Failure Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00839566
• Other study ID #: CEN_G_CA_9
• Status: Terminated
• Phase: Phase 4
• First received: January 13, 2009
• Last updated: February 14, 2017
• Start date: November 2008
• Est. completion date: July 2012

Study information

• Verified date: February 2017
• Source: Medtronic Bakken Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Examination of CRT efficacy in patients with progressive heart failure and atrial fibrillation at the same time

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: July 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure

Intervention

Procedure:
• Ablation
AV-node ablation

Other:
• Rate Control
Rate control by drug

Locations

Country	Name	City	State
Germany	Professor Dr. med. Christian Perings	Luenen

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center	Medtronic

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	End systolic left ventricular diameter		12 months
Secondary	NYHA-Class, Echo-parameters, ECG-parameters, VO2 max,6 minutes hallwalk-test		12 months