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

This study has been terminated.

Sponsor:

Collaborator:

Medtronic

Information provided by (Responsible Party):

Medtronic Bakken Research Center

ClinicalTrials.gov Identifier:

NCT00839566

First received: January 13, 2009

Last updated: October 17, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 13, 2009

Last Updated Date

October 17, 2012

Start Date ^ICMJE

November 2008

Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

End systolic left ventricular diameter [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00839566 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

NYHA-Class, Echo-parameters, ECG-parameters, VO2 max,6 minutes hallwalk-test [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Permanent Atrial Fibrillation in Heart Failure Trial

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Atrial Fibrillation
Heart Failure

Intervention ^ICMJE

Procedure: Ablation
AV-node ablation
Other: Rate Control
Rate control by drug

Study Arm (s)

Active Comparator: AV ablation
Intervention: Procedure: Ablation
Active Comparator: Rate control
Rate control by drugs

Intervention: Other: Rate Control
No Intervention: sinus rhythm

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

July 2012

Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00839566

Other Study ID Numbers ^ICMJE

CEN_G_CA_9

Has Data Monitoring Committee

Responsible Party

Medtronic Bakken Research Center

Study Sponsor ^ICMJE

Medtronic Bakken Research Center

Collaborators ^ICMJE

Medtronic

Investigators ^ICMJE

Principal Investigator:

Christian Perings, MD

marien Hospital Luenen

Information Provided By

Medtronic Bakken Research Center

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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