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出境医 / 临床实验 / Prevention of New Onset AF After TAVI (PAF-TAVI Trial) (PAF-TAVI)
Prevention of New Onset AF After TAVI (PAF-TAVI Trial) (PAF-TAVI)
Study Description
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 |
Study Design
| 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 |
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures :
- 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 :
- 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.
- 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.
- Mortality and CV mortality. [ Time Frame: 1-year follow-up ]Compare all-cause mortality and CV mortality between groups.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Incidence of permanent pacemaker implantation in the both groups. [ Time Frame: 1-year follow-up ]Need of permanent pacemaker implantation in the both groups.
- 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.
- Quality of life: Kansas City test [ Time Frame: at 30 days after NOA ]Score between 0 and 100. The best score 100.
- 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.
- Quality of life: Kansas City test [ Time Frame: at 60 days after NOAF ]Score between 0 and 100. The best score 100.
- 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.
- Quality of life: Kansas City test [ Time Frame: at 6 months after NOAF ]Score between 0 and 100. The best score 100.
- 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.
- Quality of life: Kansas City test [ Time Frame: 1-year follow-up ]Score between 0 and 100. The best score 100.
- Readmissions due to CV causes [ Time Frame: 1-year follow-up ]Compare the number of readmissions due to CV causes
- 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.
- 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.
- 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.
- 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.
- 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
- 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
- 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
- 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
- Incidence of Acute renal failure [ Time Frame: baseline ]Compare the number of events due to acute renal failure between groups
- Incidence of Acute renal failure [ Time Frame: 30 days after NOA ]Compare the number of events due to acute renal failure between groups
Eligibility Criteria
| 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
Contacts and Locations
Contacts
| 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
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 30, 2019 | ||||||||
| First Posted Date ICMJE | June 19, 2019 | ||||||||
| Last Update Posted Date | June 19, 2019 | ||||||||
| Estimated Study Start Date ICMJE | June 30, 2019 | ||||||||
| Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Prevention of New Onset AF After TAVI (PAF-TAVI Trial) | ||||||||
| Official Title ICMJE | Usefulness of Amiodarone for the Prevention of New Onset Atrial Fibrillation After Transcatheter Aortic Valve Implantation: a Randomized Controlled Trial | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 3 | ||||||||
| Study Design ICMJE | 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 |
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| Condition ICMJE | Atrial Fibrillation New Onset | ||||||||
| Intervention ICMJE | Procedure: transcatheter aortic valve implantation
transcatheter aortic valve implantation
|
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE |
120 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | June 30, 2022 | ||||||||
| Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | Not Provided | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03991754 | ||||||||
| Other Study ID Numbers ICMJE | 19/147-R_M | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Luis Nombela Franco, Hospital San Carlos, Madrid | ||||||||
| Study Sponsor ICMJE | Luis Nombela Franco | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | Hospital San Carlos, Madrid | ||||||||
| Verification Date | June 2019 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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