To assess the optimal ablation duration using the second generation cryoballoon for isolation of pulmonary veins in the treatment of atrial fibrillation.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Acute success (=entrance and exitblock) of pulmonary vein isolation.
Secondary outcome
a) (Imminent) complications, defined as:
1. Phrenic nerve palsy or diminishment of diaphragm excursion during
cryo-ablation.
2. Temperatures reaching <12 C in the oesopaghus during cryoablation.
3. Other complications such as delayed gastric emptying, pericardial
fluid/tamponade, hemoptoe, vascular complications.
b) Acute success of PVI after 1 freezing cycle
c) Duration of thaw phase (= time between end of freezing to automatic
deflation of the balloon) related to acute success of PVI
d) Procedure time, fluoroscopy time, amount of contrast used
e) LET development during and after ablation and relation of LET with balloon
temperatures measured by the console.
f) AF recurrence after 1 year follow up.
Background summary
Cryoballoon based therapy is an established therapy for the treatment of
(paroxysmal) atrial fibrillation. However, with the rapid evolution in
cryoablation technique and its increased effectiveness, the risk of
complications increases. Therefore it is of utmost importance to define the
optimal duration of cryoballoon ablation time.
Study objective
To assess the optimal ablation duration using the second generation cryoballoon
for isolation of pulmonary veins in the treatment of atrial fibrillation.
Study design
The study is designed as a prospective multicentre randomized efficacy study.
Intervention
Patients will be randomized to 2 cycles of 1, 2 or 3 minutes of cryoballoon
ablation after reaching the temperature "plateau phase*.
Study burden and risks
Since in this study a procedure which is common clinical practice will be
performed, there is no extra risk or burden associated with the intervention.
Koningsplein 1
Enschede 7512 KZ
NL
Koningsplein 1
Enschede 7512 KZ
NL
Listed location countries
Age
Inclusion criteria
* Paroxysmal atrial fibrillation eligible for PVI according to current international guidelines.
* Age < 75 years.
* Willing and able to sign informed consent.
* Willing to and capable of following the requested study procedures.
Exclusion criteria
* Age < 18 years.
* Pregnancy
* Life or follow-up expectancy < 12 months.
* Previous PVI.
* Contrast allergy.
* Creatin clearance level < 60.
* LVEF < 40%
* Abnormal left atrium anatomy defined as number of PV*s * 2 per side or LA diameter >50mm (measured in the parasternal long axis, as assessed with transthoracic echocardiography) or >40cc/m2. This will lead to exclusion after inclusion but before randomisation.
Design
Recruitment
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 | In clinicaltrials.gov, nog geen identificatienummer bekend |
| CCMO | NL47337.044.13 |