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

NCT ID: NCT00839566

Last Updated: 2025-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2012-07-31

Brief Summary

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

Detailed Description

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Conditions

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Atrial Fibrillation Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AV ablation

Group Type EXPERIMENTAL

Ablation

Intervention Type PROCEDURE

AV-node ablation

Rate control

Rate control by drugs

Group Type ACTIVE_COMPARATOR

Rate Control

Intervention Type OTHER

Rate control by drug

Sinus rhythm

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ablation

AV-node ablation

Intervention Type PROCEDURE

Rate Control

Rate control by drug

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christian Perings, MD

Role: PRINCIPAL_INVESTIGATOR

marien Hospital Luenen

Locations

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Professor Dr. med. Christian Perings

Lünen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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CEN_G_CA_9

Identifier Type: -

Identifier Source: org_study_id

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