Oral Anticoagulation after Successfull Pulmonary Vein Ablatio

Phase 1

• Conditions: atrial fibriallation; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-003492-35-DE
• Lead Sponsor: niversity of Bonn

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-17
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 630

Inclusion Criteria

- Written informed consent
- Patients undergoing circumferential antral PV ablation for non-valvular (mitral regurgitation less than moderate- severe; no relevant mitral ste-nosis with a mean pressure gradient >5mmHg) symptomatic, paroxys-mal AF or persistent AF (duration < 12 months) with risk factors resulting in a CHA2DS2VASc score =2, using a cooled tip RF-, laser- or cryo-balloon-catheter.
- CHA2DS2VASc score =2

Randomization criteria:
- Sinus rhythm (as assessed by 72h Holter ECG) following the 3 months blanking and 3 months observation period after first or second pulmonary vein ablation procedure
- No clinical evidence of recurrent AF after completing 3 months blanking and 3 months observation period as assessed by symptoms
- No other relevant contraindication for OAC assessed by randomization MRI of the brain
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 315
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 315

Exclusion Criteria

1.Severe mental retardation or psychiatrical disorder resulting in incapability to adequately understand nature, significance, implications and risks estimate the risks-and benefits of study parcipitation (i.e. bipolar disor-ders, severe depression, suicidal tendencies, among others) as judged by the local physician, ongoing, drug or alcohol addiction (> 8 drinks/week)
2.Pregnancy /breast feeding
3.Severely impaired renal function, GFR < 30 ml/min
4.Impaired liver function (ALT/AST transaminase count 3fold higher than normal values) or liver disease with reduced life expectancy <1 year
5.Valvular AF (less than moderate- severe; no relevant mitral stenosis with a mean pressure gradient >5mmHg)
6.Long standing persistent (>12 months) and permanent AF
7.NSTEMI/STEMI/implantated drug eluting stent with indication for dual antiplatelet therapy within 12 months before enrolment
8.History of complex left atrial ablation procedures. One previous PVI allowed.
9.Clinical indication for extended left atrial ablation procedures (lines, CFAE-, rotor-ablation)
10.History or presence of left atrial or ventricular thrombus
11.History of stroke / TIA independent from etiology
12.Acute major bleedings
13.Lesion or condition, if considered a significant risk factor for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities
14.Need for concomitant anitcoagulation in addition to dabigatran
15.History of previous surgery resulting in contraindication for OAC
16.History of malignoma resulting in contraindication for OAC
17.Mechanical prosthetic heart valve or other indication for permanent OAC
18.Contraindication for MRI (i.e. metallical surgical implants unsuitable for MRI, cerebral port systems, wearing of magnetic or metallic objects that cannot be removed from the body (such as body piercing, implanted electrodes, contraceptive coil), inability to lie on the back for an extend-ed period of time, uncontrollable claustrophobia, hypersensitivity to noise etc.). Pacemaker and ICD-patients may be included at the dis-cretion of the local investigators/radiologists if MRI is warranted
19.Hypersensitivity against dabigatran or other ingredients of the medical product
20.Concomitant medication with dronedarone, ketoconazole, itraconazole, cyclosporine, tacrolimus or other interacting drugs as specified in the drug information
21.Simultaneous participation in any clinical trial involving administration of an investigational medicinal product within 30 days prior to clinical trial beginning
22.Females of childbearing potential, who are not using or not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices) unless they are surgically sterilized / hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases
23.Conditions which interfere with the study treatment at the discretion of the investigator

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified