The primary objective of this study is to evaluate if PVI performed with cryoballoon and other cryocatheters is superior to AAD as first-line therapy in preventing atrial arrhythmia recurrences
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is freedom from any atrial arrhythmia recurrence at 12
months (at least one episode of AF, atrial flutter or atrial tachycardia with a
duration > 30 seconds documented by 7 day Holter ECG or any other printed ECG
recording following a blanking period or a dosing optimizing period of 3
months).
Secondary outcome
Secondary endpoint 1
The quality of life of the two arms measured by SF-36 Health Survey and Atrial
Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaires will be compared
at 12 months follow-up.
Secondary endpoint 2
Hospital or emergency services accesses due to symptoms caused by documented
atrial arrhythmias will be compared in the two arms at 12 months follow-up.
Secondary endpoint 3
Freedom from occurrence of AF (after 3 months blanking period) will be compared
between the two arms at 12 months follow-up.
Secondary endpoint 4
Freedom from occurrence of documented left atrial tachycardia and typical - or
atypical left atrial flutter (after 3 months blanking period or AAD
optimization period) will be compared between the two arms at 12 months
follow-up.
Secondary endpoint 5
Symptomatic palpitations burden will be evaluated by mean of Patient*s diary
information and compared between the two arms at 12 months follow-up.
Secondary endpoint 6
Severe adverse events incidence will be compared between the two arms during
the whole course of the study.
Secondary endpoint 7
Freedom from persistent AF (AF episode lasting longer than 7 days or
interrupted by pharmacological or electrical cardioversion after 48h from the
onset of the episode) will be compared between the two arms at 12 months
follow-up.
Secondary endpoint 8
Echocardiographic left atrial parameters will be compared between the two arms
at 6 and 12 months follow ups.
Secondary endpoint 9
Frequency, type and associated cost of health care utilization will be compared
between the two arms at 12 months follow-up.
Background summary
see page 13-16 of the protocol
Study objective
The primary objective of this study is to evaluate if PVI performed with
cryoballoon and other cryocatheters is superior to AAD as first-line therapy in
preventing atrial arrhythmia recurrences
Study design
Prospective, multi center, open-label, randomized, interventional post market
release study
Intervention
Cryo-ablation in the pulmonary vein
Study burden and risks
Standard risks associated with the medical devices used in this study, an
analysis of Adverse Device Effects, residual risks associated with the
investigational device, as identified in the risk analysis report and a history
of modification or recall of device under investigation or equivalent devices
are listed in the Investigator*s Brochure.
Endepolsdomein 5
Maastricht 6229 GW
NL
Endepolsdomein 5
Maastricht 6229 GW
NL
Listed location countries
Age
Inclusion criteria
* Subject has been diagnosed with symptomatic paroxysmal atrial fibrillation as defined above and at least two symptomatic episodes in the last six months prior to inclusion.
* At least one episode of AF must be documented during the prior year by any kind of ECG recording.
* Subject has structural normal heart with an LVEF * 50%, thickness of the inter-ventricular septum *12 mm and left atrium diameters (short axis) < 46 mm obtained by transthoracic echocardiography.
* Subject has normal ECG parameters (QRS width in the 12 channel surface ECG *120 ms, QTc * interval < 440 ms, PQ * interval * 210 ms; all parameters should be measured at sinus rhythm).
* Subject is at least 18 and * 75years old.
* Subject is able and willing to give informed consent.
Exclusion criteria
* Subject developed persistent AF at least once in history (electrical or pharmacological cardioversion after 48h or episode duration >7 days).
* Subject has documented typical atrial flutter.
* Subject has any history of successful or unsuccessful treatment of AF with class I or III antiarrhythmic or sotalol with the intention to prevent an AF recurrence. Patients pretreated with above AAD at maximum 48 hours with the intention to convert an AF episode are allowed.
* Subject had any previous left atrial ablation.
* Subject had any previous cardiac surgery, e.g. prosthetic valves.
* Subject has permanent pacemaker or defibrillator implant.
* Subject has 2° type II, 3° degree AV-block or left/right bundle branch block pattern.
* Subject has unstable angina pectoris.
* Subject has history of previous myocardial infarction or percutaneous intervention during the last three months.
* Subject has symptomatic carotid stenosis.
* Subject has chronic obstructive pulmonary disease with detected pulmonary hypertension or any other evidence of significant lung disease.
* Subject has any contraindication for oral anticoagulation.
* Subject has any history of previous transient ischemic attack or stroke.
* Subject has known intra-cardiac thrombus formation.
* Subject has any significant congenital heart defect corrected or not (except for patent foramen ovale that is allowed).
* Subject has evidence of congestive heart failure (NYHA class II, III or IV) in sinus rhythm.
* Subject has hypertrophic cardiomyopathy.
* Subject has abnormal long or short QT interval, signs of Brugada syndrome, known inheriting ion channel disease on the family, arrhythmogenic right ventricular dysplasia.
* Subject has sarcoidosis.
* Subject has pulmonary vein stent.
* Subject has myxoma.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | Clinicaltrials.gov |
| CCMO | NL57677.078.16 |