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Hybrid Versus Catheter Ablation in Persistent AF (HARTCAP-AF)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Hybrid Ablation
Catheter Ablation
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Hybrid Ablation, Catheter Ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Known with a history of symptomatic persistent AF or longstanding persistent atrial fibrillation,
  • Refractory to or intolerant of at least one antiarrhythmic drug class I or III,
  • At least 18 years of age,
  • Mentally able and willing to give informed consent.

Exclusion Criteria:

  • Previous ablation procedure,
  • Longstanding persistent AF > 3 years,
  • Paroxysmal atrial fibrillation. Successful cardioversion within 48 hours of onset of the arrhythmia will be also considered paroxysmal. In patients with paroxysmal and persistent AF, the dominant pattern should be taken to categorize,
  • Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or other reversible or non-cardiovascular cause,
  • Presence of left atrial appendage (LAA) thrombus,
  • Left atrial size ≥ 60mm (PLAX-view on TEE),
  • Left ventricular ejection fraction < 40%,
  • In need for other cardiac surgery then AF treatment within 12 months,
  • Intolerance to heparin and warfarin,
  • Unable to undergo TEE,
  • Sick-sinus-syndrome
  • Mitral valve insufficiency > Iº
  • Carotic stenosis > 80%,
  • Active infection or sepsis,
  • Pleural adhesions,
  • Elevated hemi diaphragm
  • Significant pulmonary dysfunction as assessed by preoperative lung testing,
  • Chronic obstructive pulmonary disease with a FEV1 or VC < 50% predicted
  • History of cerebrovascular accident (CVA) or transient ischemic attack (TIA),
  • History of blood clotting abnormalities,
  • History of thoracic radiation,
  • History of pericarditis,
  • History of cardiac tamponade,
  • History of thoracotomy or cardiac surgery,
  • Body-mass-index > 40,
  • Pregnancy,
  • Life expectancy less than 12 months,
  • Participation in any other clinical study involving an investigational drug or device.

Sites / Locations

  • Maastricht University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Hybrid Ablation

Catheter Ablation

Arm Description

Epicardial surgical ablation performed thoracoscopically with occlusion/removal of the LAA combined with percutaneous endocardial ablation (one-stage).

Percutaneous endocardial catheter ablation, with optional repeated catheter ablation(s).

Outcomes

Primary Outcome Measures

Freedom from any AT off antiarrhythmic drugs class I or III lasting > 5 minutes after the blanking period, evaluated by any ECG-tracing and 7-day holter.
Major complications during follow-up

Secondary Outcome Measures

Full Information

First Posted
May 4, 2015
Last Updated
May 14, 2019
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02441738
Brief Title
Hybrid Versus Catheter Ablation in Persistent AF
Acronym
HARTCAP-AF
Official Title
Hybrid Thoracoscopic Surgical and Transvenous Catheter Ablation Versus Transvenous Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 31, 2016 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Atrial fibrillation (AF) is the most common cardiac arrhythmia with a lifetime risk of developing AF of 1 in 4 people aged over 40. Besides hemodynamic compromises stroke remains the most feared complication of AF with an increase in risk by 5-fold. Catheter ablation has evolved as a standardized treatment option in paroxysmal AF. Due to the advanced electrical and structural remodeling the single procedural results of catheter ablation for persistent and longstanding persistent AF are rather disappointing without a proven superiority of any applied strategy compared to others. However, repeated catheter ablation can achieve better results. The surgical (epicardial) approach seems to be more effective, though still a significant amount of failures exist. Checking the epicardial ablation lines and if necessary making additional endocardial lines (which is a hybrid ablation) is expected to be most efficacious in avoiding lesion gaps and providing the most complete lesion set. The study objective of this pilot trial is to compare the safety and efficacy of catheter ablation within 6 months versus a hybrid ablation consisting of endoscopic epicardial surgery combined with endocardial catheter ablation (performed one-stage) in preventing the recurrence of atrial fibrillation (AF) in symptomatic, drug refractory patients with persistent or longstanding persistent atrial fibrillation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation, Hybrid Ablation, Catheter Ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hybrid Ablation
Arm Type
Active Comparator
Arm Description
Epicardial surgical ablation performed thoracoscopically with occlusion/removal of the LAA combined with percutaneous endocardial ablation (one-stage).
Arm Title
Catheter Ablation
Arm Type
Active Comparator
Arm Description
Percutaneous endocardial catheter ablation, with optional repeated catheter ablation(s).
Intervention Type
Procedure
Intervention Name(s)
Hybrid Ablation
Intervention Description
The procedure will be performed following standard of care guidelines.
Intervention Type
Procedure
Intervention Name(s)
Catheter Ablation
Intervention Description
The procedure will be performed following standard of care guidelines.
Primary Outcome Measure Information:
Title
Freedom from any AT off antiarrhythmic drugs class I or III lasting > 5 minutes after the blanking period, evaluated by any ECG-tracing and 7-day holter.
Time Frame
12 Months
Title
Major complications during follow-up
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Known with a history of symptomatic persistent AF or longstanding persistent atrial fibrillation, Refractory to or intolerant of at least one antiarrhythmic drug class I or III, At least 18 years of age, Mentally able and willing to give informed consent. Exclusion Criteria: Previous ablation procedure, Longstanding persistent AF > 3 years, Paroxysmal atrial fibrillation. Successful cardioversion within 48 hours of onset of the arrhythmia will be also considered paroxysmal. In patients with paroxysmal and persistent AF, the dominant pattern should be taken to categorize, Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or other reversible or non-cardiovascular cause, Presence of left atrial appendage (LAA) thrombus, Left atrial size ≥ 60mm (PLAX-view on TEE), Left ventricular ejection fraction < 40%, In need for other cardiac surgery then AF treatment within 12 months, Intolerance to heparin and warfarin, Unable to undergo TEE, Sick-sinus-syndrome Mitral valve insufficiency > Iº Carotic stenosis > 80%, Active infection or sepsis, Pleural adhesions, Elevated hemi diaphragm Significant pulmonary dysfunction as assessed by preoperative lung testing, Chronic obstructive pulmonary disease with a FEV1 or VC < 50% predicted History of cerebrovascular accident (CVA) or transient ischemic attack (TIA), History of blood clotting abnormalities, History of thoracic radiation, History of pericarditis, History of cardiac tamponade, History of thoracotomy or cardiac surgery, Body-mass-index > 40, Pregnancy, Life expectancy less than 12 months, Participation in any other clinical study involving an investigational drug or device.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Pison, MD, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark La Meir, MD, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229HX
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
31221218
Citation
Vroomen M, La Meir M, Maesen B, Luermans JGL, Vernooy K, Essers B, de Greef BTA, Maessen JG, Crijns HJ, Pison L. Hybrid thoracoscopic surgical and transvenous catheter ablation versus transvenous catheter ablation in persistent and longstanding persistent atrial fibrillation (HARTCAP-AF): study protocol for a randomized trial. Trials. 2019 Jun 20;20(1):370. doi: 10.1186/s13063-019-3365-9.
Results Reference
derived

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Hybrid Versus Catheter Ablation in Persistent AF

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