PAF-HEFT (Permanent Atrial Fibrillation in Heart Failure... | NCT00839566

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

NCT00839566

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Status

Terminated

Last Update Posted

Jul 3, 2025Actual

Enrollment

12Actual

Phase

Phase 4

Conditions

Atrial Fibrillation
Heart Failure

Interventions

Ablation
Rate Control

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Number of eligible patients too small.

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Mar 2012Actual

Completion Date

Jul 2012Actual

First Submitted Date

Jan 13, 2009

First Submission Date that Met QC Criteria

Feb 6, 2009

First Posted Date

Feb 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2025

Last Update Posted Date

Jul 3, 2025Actual

Name	Class
Medtronic	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AV ablation	Experimental		Procedure: Ablation
Rate control	Active Comparator	Rate control by drugs	Other: Rate Control
Sinus rhythm	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ablation	Procedure	AV-node ablation	AV ablation
Rate Control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
End systolic left ventricular diameter		12 months

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christian Perings, MD	marien Hospital Luenen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Professor Dr. med. Christian Perings		Lünen		44534	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation
D006333	Heart Failure

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006339	Heart Rate

Ancestor Terms

ID	Term
D055986	Vital Signs
D010808	Physical Examination
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided