Atrial FibrillationPhase 4PAF-HEFTNCT00839566
PAF-HEFT (Permanent Atrial Fibrillation in Heart Failure Trial)
A Phase 4 study testing Ablation in people with Atrial Fibrillation and Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Germany.
Trial summary
Examination of CRT efficacy in patients with progressive heart failure and atrial fibrillation at the same time Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Heart Failure
- What is being tested?
- Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2008to Jul 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Permanent Atrial Fibrillation in Heart Failure Trial
Examination of CRT efficacy in patients with progressive heart failure and atrial fibrillation at the same time
- Conditions
- Atrial Fibrillation, Heart Failure
- Being tested
- Ablation, Rate Control
- Keywords
- Atrial Fibrillation, Heart Failure
- Medical subject headings
- Atrial Fibrillation, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AblationProcedure or surgery
AV-node ablation
Rate ControlOther
Rate control by drug
| Study group | Role | What they receive |
|---|---|---|
| AV ablation | Experimental | Not described Receives: Procedure: Ablation |
| Rate control | Active comparator | Rate control by drugs Receives: Other: Rate Control |
| Sinus rhythm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
End systolic left ventricular diameter
Measured: 12 months
Secondary outcomes (1)
NYHA-Class, Echo-parameters, ECG-parameters, VO2 max,6 minutes hallwalk-test
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2009 (estimated)
- Study startNov 2008
- Primary completionMar 2012
- Study completionJul 2012
Why it stopped: Number of eligible patients too small.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Christian Perings, MD, Principal investigator, marien Hospital Luenen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00839566
- Sponsor's protocol ID
- CEN_G_CA_9
- Acronym
- PAF-HEFT
- Status last verified
- Feb 2017
- First submitted
- 13 Jan 2009
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Not applicable as NO is selected above for 'Plan to share IPD?"
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Permanent Atrial Fibrillation in Heart Failure Trial
- ClinicalTrials.gov ID
- NCT00839566
- Acronym / sponsor ID
- PAF-HEFT / CEN_G_CA_9
- Conditions
- Atrial Fibrillation, Heart Failure
- Keywords
- Atrial Fibrillation, Heart Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Number of eligible patients too small.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- Nov 2008
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 9 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Examination of CRT efficacy in patients with progressive heart failure and atrial fibrillation at the same time
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AV ablation | Experimental | Procedure: Ablation |
| Rate control | Active comparator | Other: Rate ControlRate control by drugs |
| Sinus rhythm | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- LVEF <35%
- QRS time ≥150ms LBB
- NYHA classification ≥ NYHA III
- permanent (> 6 months) Atrial Fibrillation
- sinus rhythm (control group)
Key exclusion criteria (7 listed)
- exchange of the current CRT device
- mitral incompetence (2. degree)
- no compliance
- participation in another study
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AblationAV-node ablation | Procedure or surgery | AV ablation |
| Rate ControlRate control by drug | Other | Rate control |
Primary outcome
End systolic left ventricular diameter
Time frame: 12 months
1 secondary outcome
NYHA-Class, Echo-parameters, ECG-parameters, VO2 max,6 minutes hallwalk-test
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Number of eligible patients too small.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No. Not applicable as NO is selected above for 'Plan to share IPD?"
Related trials for Atrial Fibrillation
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Perings, MD principal investigator
marien Hospital Luenen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ablation in people with Atrial Fibrillation and Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Number of eligible patients too small.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
End systolic left ventricular diameter (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.