AzTrials
AzTrials

Symptomatic Paroxysmal Atrial FibrillationPhase 4MACPAFNCT01061931

Mesh Ablator Versus Cryoballoon Pulmonary Vein Ablation of Symptomatic Paroxysmal Atrial Fibrillation

A Phase 4 study testing Arctic Front® catheter vs. HD Mesh Ablator® catheter in people with Symptomatic Paroxysmal Atrial Fibrillation, run by Charite University, Berlin, Germany at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The purpose of this prospective randomized single-center trial is to compare efficiency and safety of two pulmonary vein ablation systems in patients with symptomatic paroxysmal atrial fibrillation using the Arctic Front® versus the HD Mesh Ablator® catheter. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Arctic Front® catheter vs. HD Mesh Ablator® catheter
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteGermany
Study dates
Mar 2009to Nov 2011
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with ECG-documented symptomatic paroxysmal atrial fibrillation and at least one ineffective antiarrhythmic drug treatment

Who cannot join

  • Previous ablation procedure for atrial fibrillation or cardiac surgery within 3 months
  • Left atrial diameter > 50mm or ejection fraction < 35%
  • Instable coronary artery disease or clinically relevant cardiac valve insufficiency
  • Hyperthyroidism, pregnancy or lactation; coumadin or heparin intolerance
  • Concomitant disease with expected lifespan < 2 years
  • Contraindications for MRI or acute cerebral infarction detected by brain MRI immediately (< 24 hours) before catheter ablation.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Charité, University Medicine Berlin, Campus Benjamin Franklin, Hindenburgdamm 30

    Berlin, 12200

Other trials in Germany

About this study

Official title: HD Mesh Ablator Versus Cryoballoon Pulmonary Vein Ablation of Symptomatic Paroxysmal Atrial Fibrillation - Efficiency and Safety of PV Ablation Systems

The purpose of this prospective randomized single-center trial is to compare efficiency and safety of two pulmonary vein ablation systems in patients with symptomatic paroxysmal atrial fibrillation using the Arctic Front® versus the HD Mesh Ablator® catheter.

Read the detailed description

Primary objective:

  • Efficacy of pulmonary vein isolation defined by achieving an exit block for all pulmonary veins per patient.

Secondary objectives:

  • Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain MRI prior and within 2 days after PV ablation.
  • Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain MRI within 6 months after PV ablation.
  • Determination of spontaneous recurrence rate of atrial fibrillation using a subcutaneously implanted loop recorder (Reveal XT®).
  • Characterization of non-neurological major complications (death, atrial-esophageal fistula, pulmonary vein stenosis, pericardial tamponade)
  • Rate of iatrogenic interatrial septal defects after transseptal puncture for PV ablation.
Being tested
Arctic Front® catheter vs. HD Mesh Ablator® catheter
Keywords
MRI, left-sided atrial catheter ablation, paroxysmal atrial fibrillation, cryoballoon technique, mesh ablator catheter, stroke, silent stroke, major complications
Medical subject headings
Atrial Fibrillation, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Arctic Front® catheter vs. HD Mesh Ablator® catheterProcedure or surgery

    Pulmonary vein ablation in patients with symptomatic paroxysmal atrial fibrillation using the Arctic Front® catheter versus the HD Mesh Ablator® catheter

Study groups in NCT01061931
Study groupRoleWhat they receive
Arctic Front® catheterActive comparatorNot described
Receives: Procedure: Arctic Front® catheter vs. HD Mesh Ablator® catheter
HD Mesh Ablator® catheterActive comparatorNot described
Receives: Procedure: Arctic Front® catheter vs. HD Mesh Ablator® catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of pulmonary vein isolation defined by achieving an exit block for all pulmonary veins per patient

    Measured: During ablation procedure

Secondary outcomes (5)

  1. Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain MRI

    Measured: within 2 days after catheter ablation

  2. Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain MRI

    Measured: 6 months after catheter ablation

  3. Determination of spontaneous recurrence rate of atrial fibrillation using a subcutaneously implanted loop recorder (Reveal XT®)

    Measured: 1 year after catheter ablation

  4. Characterization of non-neurologic major complications (death, atrial-esophageal fistula, pulmonary vein stenosis, pericardial tamponade)

    Measured: within 1 month after catheter ablation

  5. Rate of iatrogenic interatrial septal defects after transseptal puncture for left-sided atrial catheter ablation

    Measured: 1 year after catheter ablation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2010 (estimated)
  2. Study startMar 2009
  3. Primary completionNov 2010
  4. Study completionNov 2011

Why it stopped: reason

Resources

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
Single blind
Who is masked
Investigator
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01061931
Sponsor's protocol ID
MACPAF
Other IDs
4-087-08
Acronym
MACPAF
Status last verified
Jun 2014
First submitted
2 Feb 2010
Last updated
24 Jun 2014
Results posted
No
Data monitoring committee
No

Publications

  • Herm J, Schirdewan A, Koch L, Wutzler A, Fiebach JB, Endres M, Kopp UA, Haeusler KG. Impact of atrial fibrillation burden on cognitive function after left atrial ablation - Results of the MACPAF study. J Clin Neurosci. 2020 Mar;73:168-172. doi: 10.1016/j.jocn.2019.12.030. Epub 2020 Jan 25.

    PubMed 31992513

  • Schirdewan A, Herm J, Roser M, Landmesser U, Endres M, Koch L, Haeusler KG. Loop Recorder Detected High Rate of Atrial Fibrillation Recurrence after a Single Balloon- or Basket-Based Ablation of Paroxysmal Atrial Fibrillation: Results of the MACPAF Study. Front Cardiovasc Med. 2017 Feb 13;4:4. doi: 10.3389/fcvm.2017.00004. eCollection 2017.

    PubMed 28243592

  • Herm J, Fiebach JB, Koch L, Kopp UA, Kunze C, Wollboldt C, Brunecker P, Schultheiss HP, Schirdewan A, Endres M, Haeusler KG. Neuropsychological effects of MRI-detected brain lesions after left atrial catheter ablation for atrial fibrillation: long-term results of the MACPAF study. Circ Arrhythm Electrophysiol. 2013 Oct;6(5):843-50. doi: 10.1161/CIRCEP.113.000174. Epub 2013 Aug 29.

    PubMed 23989301

  • Haeusler KG, Koch L, Herm J, Kopp UA, Heuschmann PU, Endres M, Schultheiss HP, Schirdewan A, Fiebach JB. 3 Tesla MRI-detected brain lesions after pulmonary vein isolation for atrial fibrillation: results of the MACPAF study. J Cardiovasc Electrophysiol. 2013 Jan;24(1):14-21. doi: 10.1111/j.1540-8167.2012.02420.x. Epub 2012 Aug 22.

    PubMed 22913568

  • Koch L, Haeusler KG, Herm J, Safak E, Fischer R, Malzahn U, Werncke T, Heuschmann PU, Endres M, Fiebach JB, Schultheiss HP, Schirdewan A. Mesh ablator vs. cryoballoon pulmonary vein ablation of symptomatic paroxysmal atrial fibrillation: results of the MACPAF study. Europace. 2012 Oct;14(10):1441-9. doi: 10.1093/europace/eus084. Epub 2012 Apr 20.

    PubMed 22523379

  • Haeusler KG, Koch L, Ueberreiter J, Coban N, Safak E, Kunze C, Villringer K, Endres M, Schultheiss HP, Fiebach JB, Schirdewan A. Safety and reliability of the insertable Reveal XT recorder in patients undergoing 3 Tesla brain magnetic resonance imaging. Heart Rhythm. 2011 Mar;8(3):373-6. doi: 10.1016/j.hrthm.2010.11.008. Epub 2010 Nov 9.

    PubMed 21070885

  • Haeusler KG, Koch L, Ueberreiter J, Endres M, Schultheiss HP, Heuschmann PU, Schirdewan A, Fiebach JB. Stroke risk associated with balloon based catheter ablation for atrial fibrillation: Rationale and design of the MACPAF Study. BMC Neurol. 2010 Jul 21;10:63. doi: 10.1186/1471-2377-10-63.

    PubMed 20663131

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Arctic Front® catheter vs. HD Mesh Ablator® catheter in people with Symptomatic Paroxysmal Atrial Fibrillation, run by Charite University, Berlin, Germany 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 1 inclusion and 6 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 24 Jun 2014. 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: reason). 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?

Efficacy of pulmonary vein isolation defined by achieving an exit block for all pulmonary veins per patient (time frame: During ablation procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01061931, which also lists 7 linked publications.

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 24 Jun 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in