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Prevention of New Onset AF After TAVI (PAF-TAVI Trial) (PAF-TAVI)

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ClinicalTrials.gov Identifier: NCT03991754
Recruitment Status : Not yet recruiting
First Posted : June 19, 2019
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Luis Nombela Franco, Hospital San Carlos, Madrid

Brief Summary:

New onset atrial fibrillation (NOAF) is a relatively frequent complication after transcatheter aortic valve implantation (TAVI). This complication has been related with worse short and long-term outcomes, including higher stroke, mortality, readmission and bleeding rates. The aim of this study is to evaluate the effectiveness of amiodarone in the prevention of the NOAF after TAVI.

The study is a multicenter, randomized double-blinded trial including 120 patients without prior AF that will undergo TAVI in a scheduled basis. Patients will be randomized to be treated with amiodarone orally from 6 days before to 6 days after the TAVI procedure versus placebo.

All the patients will be monitored with a 60-day holter to evaluate NOAF incidence. The main objective is NOAF incidence after TAVI at 30-day. Secondary endpoints are the incidence of NOAF, stroke, bleeding and all-cause and cardiovascular mortality in both groups at 60-day. Results of this study can contribute to optimize TAVI results in a short and long term, potentially improving the survival and quality of life in this group of frail patients with comorbidities, which makes them vulnerable to NOAF, stroke, bleeding, heart failure and readmission.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation New Onset Procedure: transcatheter aortic valve implantation Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase III Clinical trial, multiple sites, controlled, randomized, double blind, parallel groups.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Usefulness of Amiodarone for the Prevention of New Onset Atrial Fibrillation After Transcatheter Aortic Valve Implantation: a Randomized Controlled Trial
Estimated Study Start Date : June 30, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Amiodarone
Oral Amiodarone 600mg / day, divided into 3 doses (200mg every 8 hours) for 6 days before the procedure and then 400mg / day, divided into 2 doses (200mg every 12 hours) during the 6 days following the implantation of TAVI.
Procedure: transcatheter aortic valve implantation
transcatheter aortic valve implantation

Placebo Comparator: Control
Patients assigned to the control group will receive placebo tablets identical to those of amiodarone. The administration of these tablets will follow the same scheme as in the amiodarone group. Therefore, they will receive placebo tablets orally, 1 tablet every 8 hours 6 days before the procedure and then 1 tablet every 12 hours during the 6 days following the implantation of TAVI
Procedure: transcatheter aortic valve implantation
transcatheter aortic valve implantation




Primary Outcome Measures :
  1. Incidence of new onset atrial fibrillation [ Time Frame: 30 days after transcatheter aortic valve implantation (TAVI) ]
    Compare the incidence of new onset atrial fibrillation (NOAF) on patients that receive oral amiodarone versus placebo. NOAF is defined as an irregular rhythm without P wave and irregular ventricular response during at least 30 seconds, detected in the electrocardiographic monitoring during the post-procedural period or in the 60 days ECG Holter in a patient without previous history of atrial fibrillation. NOAF incidence within 30-day after the TAVI procedure is the primary end-point.


Secondary Outcome Measures :
  1. Incidence of new onset atrial fibrillation [ Time Frame: 60 days after transcatheter aortic valve implantation (TAVI) ]
    Compare the incidence of new onset atrial fibrillation (NOAF) on patients that receive oral amiodarone versus placebo. NOAF is defined as an irregular rhythm without P wave and irregular ventricular response during at least 30 seconds, detected in the electrocardiographic monitoring during the post-procedural period or in the 60 days ECG Holter in a patient without previous history of atrial fibrillation. NOAF incidence within 30-day after the TAVI procedure is the primary end-point.

  2. Effect of the amiodarone [ Time Frame: 1-year follow-up ]
    Analyze the effect of the amiodarone in the moment of appearance and the burden of AF after TAVI. AF burden, defined as the relative length of the AF registers in relation to the time in sinus rhythm.

  3. Mortality and CV mortality. [ Time Frame: 1-year follow-up ]
    Compare all-cause mortality and CV mortality between groups.

  4. Number of parients with MACE [ Time Frame: at 30 days after NOAF ]
    MACE: Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate.

  5. Number of parients with MACE [ Time Frame: at 60 days after NOAF ]
    MACE: Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate.

  6. Number of parients with MACE [ Time Frame: at 6 months after NOAF ]
    MACE: Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate.

  7. Number of parients with MACE [ Time Frame: 1-year follow-up ]
    MACE: Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate.

  8. Number of adverse events related to amiodarone [ Time Frame: at 30 days after NOAF ]
    The safety evaluation will be realized by a meticulous vigilance of the adverse effects appeared in the study population.

  9. Number of adverse events related to amiodarone [ Time Frame: at 60 days after NOAF ]
    The safety evaluation will be realized by a meticulous vigilance of the adverse effects appeared in the study population.

  10. Number of adverse events related to amiodarone [ Time Frame: at 6 months after NOAF ]
    The safety evaluation will be realized by a meticulous vigilance of the adverse effects appeared in the study population.

  11. Number of adverse events related to amiodarone [ Time Frame: 1-year follow-up ]
    The safety evaluation will be realized by a meticulous vigilance of the adverse effects appeared in the study population.

  12. Incidence of permanent pacemaker implantation in the both groups. [ Time Frame: at 30 days after NOAF ]
    Need of permanent pacemaker implantation in the both groups.

  13. Incidence of permanent pacemaker implantation in the both groups. [ Time Frame: at 60 days after NOAF ]
    Need of permanent pacemaker implantation in the both groups.

  14. Incidence of permanent pacemaker implantation in the both groups. [ Time Frame: at 6 months after NOAF ]
    Need of permanent pacemaker implantation in the both groups.

  15. Incidence of permanent pacemaker implantation in the both groups. [ Time Frame: 1-year follow-up ]
    Need of permanent pacemaker implantation in the both groups.

  16. Quality of life: EuroQoL 5D [ Time Frame: at 30 days after NOA ]
    Eq-5D: EuroQoL 5 Dimensions. Score between 0 and 1. The best score 1.

  17. Quality of life: Kansas City test [ Time Frame: at 30 days after NOA ]
    Score between 0 and 100. The best score 100.

  18. Quality of life: EuroQoL 5D [ Time Frame: at 60 days after NOAF ]
    Eq-5D: EuroQoL 5 Dimensions. Score between 0 and 1. The best score 1.

  19. Quality of life: Kansas City test [ Time Frame: at 60 days after NOAF ]
    Score between 0 and 100. The best score 100.

  20. Quality of life: EuroQoL 5D [ Time Frame: at 6 months after NOAF ]
    Eq-5D: EuroQoL 5 Dimensions. Score between 0 and 1. The best score 1.

  21. Quality of life: Kansas City test [ Time Frame: at 6 months after NOAF ]
    Score between 0 and 100. The best score 100.

  22. Quality of life: EuroQoL 5D [ Time Frame: 1-year follow-up ]
    Eq-5D: EuroQoL 5 Dimensions. Score between 0 and 1. The best score 1.

  23. Quality of life: Kansas City test [ Time Frame: 1-year follow-up ]
    Score between 0 and 100. The best score 100.

  24. Readmissions due to CV causes [ Time Frame: 1-year follow-up ]
    Compare the number of readmissions due to CV causes

  25. Functional change: New York Heart Association. [ Time Frame: at 30 days after NOA ]
    Evaluate the functional change according to the NYHA scale. Score between 0 and 4. The best score 1.

  26. Functional change: New York Heart Association. [ Time Frame: at 60 days after NOAF ]
    Evaluate the functional change according to the NYHA scale. Score between 0 and 4. The best score 1.

  27. Functional change: New York Heart Association. [ Time Frame: at 6 months after NOAF ]
    Evaluate the functional change according to the NYHA scale. Score between 0 and 4. The best score 1.

  28. Functional change: New York Heart Association. [ Time Frame: 1-year follow-up ]
    Evaluate the functional change according to the NYHA scale. Score between 0 and 4. The best score 1.

  29. Capacity for the exercise [ Time Frame: at 30 days after NOA ]
    Evalue the change in capacity for the exercise, evaluated by the 6-minute walk test between groups

  30. Capacity for the exercise [ Time Frame: at 60 days after NOAF ]
    Evalue the change in capacity for the exercise, evaluated by the 6-minute walk test between groups

  31. Capacity for the exercise [ Time Frame: at 6 months after NOAF ]
    Evalue the change in capacity for the exercise, evaluated by the 6-minute walk test between groups

  32. Capacity for the exercise [ Time Frame: 1-year follow-up ]
    Evalue the change in capacity for the exercise, evaluated by the 6-minute walk test between groups

  33. Incidence of Acute renal failure [ Time Frame: baseline ]
    Compare the number of events due to acute renal failure between groups

  34. Incidence of Acute renal failure [ Time Frame: 30 days after NOA ]
    Compare the number of events due to acute renal failure between groups



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women over 18 years old. Women of childbearing age must commit to the use of contraceptive methods of assured efficacy.
  • Patients that will undergo TAVI due to aortic stenosis.
  • Sinus rhythm showed by an ECG during 72 hours previous to the inclusion in the study.

Exclusion Criteria:

  • Pregnancy or lactation. Women of childbearing age who do not have a negative pregnancy test.
  • Paroxysmal persistent or persistent AF (documented record in electrocardiogram or ECG holter)
  • Congestive heart failure with functional class NYHA IV despite optimal medical treatment.
  • Sustained hypotension (TAS < 80mmHg)
  • Severe mitral stenosis or regurgitation
  • Treatment with antiarrhythmic drugs (amiodarone included) 3 months before the procedure, treatment with beta-blockers or dihydropyrimidine calcium channel blockers are not considered an exclusion criteria.
  • Sinus bradycardia (< 50 lpm), PR interval >240 mseg or second or third degree AV block.
  • QT interval longer than 480 msec in an EKG performed in 72 hours before the inclusion, without a permanent pacemaker.
  • Clinical hypo- or hyperthyroidism, clinical or subclinical autoimmune thyroid disease, or multinodular goiter.
  • Allergy or adverse reaction known or suspected to the amiodarone.
  • Denial of the patient or inability to give informed consent.
  • Hypersensitivity to iodo
  • Concomitant drugs that, in association with amiodarone, can induce torsades de pointes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03991754


Contacts
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Contact: Luis Nombela Franco, PhD 913303000 ext 3283 luisnombela@yahoo.com
Contact: Gabriela Tirado-Conte, MD 913303000 ext 3283 gabrielatirado@gmail.com

Sponsors and Collaborators
Luis Nombela Franco

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Responsible Party: Luis Nombela Franco, Principal Investigator, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier: NCT03991754     History of Changes
Other Study ID Numbers: 19/147-R_M
First Posted: June 19, 2019    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Amiodarone
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors