The primary objective of this study is to investigate the safety and feasibility of implanting a WATCHMAN Device in a hybrid setup for AF ablation.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Cardiac therapeutic procedures
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary safety endpoint for this study comprises major complications and
includes:
* Acute death (< 7days after the procedure),
* Ischemic or hemorrhagic TIA or CVA (<7days after the procedure),
* Device embolization requiring retrieval,
* Device related complications requiring open surgery or major endovascular
intervention,
* Any bleeding related to the device that necessitates a re-operation or PRBC
transfusion * 2 Units within 24hours,
* Pericardial effusion requiring intervention (<3 months after the procedure),
* Femoral arteriovenous fistula.
The primary feasibility endpoint for this study is:
* Device success, defined as successful delivery and release of the WATCHMAN
implant into the LAA, including successful recapture and retrieval if
necessary, and residual peridevice flow is * 5 mm in width.
The primary efficacy endpoint comprises cardiovascular events during follow-up
(>7days days):
* Cardiovascular or unexplained death,
* Embolic or hemorrhagic TIA or CVA,
* Systemic embolization.
Secondary outcome
The secondary endpoints for this study are:
* Prolonged procedure time,
* Prolonged radiation exposure time and dosage,
* (Serious) Adverse Device Events ((S)ADE),
* (S)AEs.
Background 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. Stroke remains the most
feared complication of AF with an increase in risk by 5-fold, and is the
leading cause of morbidity and mortality. The left atrial appendage (LAA) is
the origin for more than 90% of the emboli in non-valvular AF. The WATCHMAN*
Left Atrial Closure Device (WATCHMAN Device, Boston Scientific) reduces the
risk of stroke by closing off the LAA. During hybrid procedures for AF, LAA
occlusion with epicardial devices is known to be difficult and not free of
risks.It thus will be interesting to study the safety and feasibility of
endocardial WATCHMAN Device implantation in a hybrid ablation approach.
Study objective
The primary objective of this study is to investigate the safety and
feasibility of implanting a WATCHMAN Device in a hybrid setup for AF ablation.
Study design
The study is designed as a prospective, non-randomized, single center study.
Ten consecutive patients will be included. The study will take place at the
Maastricht University Medical Center, situated in Maastricht, the Netherlands.
It is estimated that it will take 6-8 months to enroll the patients and a
6-months follow-up for all patients will be required. The estimated total study
duration will thus be 12 - 14 months.
Intervention
The intervention consists of the WATCHMAN Device implantation.
Study burden and risks
Patients who are included in this study, would also undergo LAA closure without
participation in the study. The study only decides to use another as usual
device, which has proven to be save, though in other settings. It is not
expected that the WATCHMAN Device in the hybrid setting will be less save than
in other settings and is even expected to be more save and more feasible than
the method which is used at the moment.
When participating in this study, compared to a hybrid ablation without use of
the WATCHMAN Device, patients will have one extra visit with TEE (at the same
day) and one extra TEE performed on a day with a standard visit. These
procedures however are related to the device implantation and are not solely
for study purposes. Patient who would undergo a WATCHMAN Device implantation in
a setting which is not hybrid, will have to undergo these same procedures.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
The patient:
* Has documented paroxysmal or (long-standing) persistent non-valvular atrial fibrillation,
* Is eligible at least for short-term OAC therapy,
* Has no other conditions that would require long-term OAC therapy, suggested by current standard medical practice, and thus is eligible to stop OAC if the LAA is sealed,
* Has a calculated CHA2DS2-VASc score of 1 or more,
* Is 18 years of age or older, able and willing to provide written informed consent.
Exclusion criteria
* Current New York Heart Association Class IV Congestive Heart Failure,
* Current thrombocytopenia (< 100x10E9/L) or anemia (hemoglobin <6.2 mmol/L),
* Active infection or sepsis,
* Resting heart rate > 110 beats per minute,
* Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the last 30 days,
* Recent myocardial infarction (within 3 months),
* Transient case of AF (i.e., secondary to recent cardiac surgery (within 3 months)),
* Planned cardioversion 30 days post implant of the WATCHMAN Device,
* Implanted mechanical valve prosthesis,
* History of obliterated LAA,
* History of heart transplantation,
* Symptomatic carotid disease (i.e., carotid stenosis >50% associated with ipsilateral transient or visual ischemic attack evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke within 6 months),
* Necessity to use long-term OAC,
* Contraindication for use of OAC or dual anti-platelet therapy,
* Contraindication for use of aspirin,
* Pregnancy or planned pregnancy during the course of the investigation,
* Life expectancy less than 2 years,
* Participation in any other clinical study involving an investigational drug or device.;Echocardiographic Exclusion Criteria (as assessed via transthoracic echocardiography (TTE) or TEE) for this study are:
* Left ventricular ejection fraction (LVEF) < 30%,
* Intracardiac thrombus as visualized by TEE within 2 days prior to implant,
* High risk patent foramen ovale,
* Current atrial septal defect and/or previous atrial septal repair or closure device,
* Significant mitral valve stenosis (i.e., MV 4. 5 cm2),
* Existing pericardial effusion of >3 mm,
* Complex atheroma with mobile plaque of the descending aorta and/or aortic arch,
* Cardiac tumor.
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 |
|---|---|
| ClinicalTrials.gov | NCTnummervolgt |
| CCMO | NL53510.068.15 |