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

June 30, 2025 updated by: Medtronic Cardiac Rhythm and Heart Failure

Permanent Atrial Fibrillation in Heart Failure Trial

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Luenen, Germany, 44534
        • Professor Dr. med. Christian Perings

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AV ablation
Procedure: Ablation
AV-node ablation
Active Comparator: Rate control
Rate control by drugs
Other: Rate Control
Rate control by drug
No Intervention: Sinus rhythm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
End systolic left ventricular diameter
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
NYHA-Class, Echo-parameters, ECG-parameters, VO2 max,6 minutes hallwalk-test
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Collaborators

Medtronic

Investigators

  • Principal Investigator: Christian Perings, MD, marien Hospital Luenen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

January 13, 2009

First Submitted That Met QC Criteria

February 6, 2009

First Posted (Estimated)

February 9, 2009

Study Record Updates

Last Update Posted (Actual)

July 3, 2025

Last Update Submitted That Met QC Criteria

June 30, 2025

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEN_G_CA_9

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not applicable as NO is selected above for 'Plan to share IPD?"

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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