Atrial Fibrillation New OnsetPhase 3PAF-TAVINCT03991754
Prevention of New Onset AF After TAVI (PAF-TAVI Trial)
A Phase 3 study testing Amiodarone in people with Atrial Fibrillation New Onset, run by Ana Belen Rivas Paterna at 6 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation New Onset
- What is being tested?
- Amiodarone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 6 sitesSpain
- Study dates
- 30 Jan 2020to 13 Jun 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
Hospital Clínic Barcelona
Barcelona
Hospital Clínico San Carlos
Madrid
Hospital de La Princesa
Madrid
Complejo Asistencial Universitario de Salamanca
Salamanca, Salamanca
Hospital Marqués de Valdecilla
Santander
Hospital Clínico de Valladolid
Valladolid
About this study
Official title: Usefulness of Amiodarone for the Prevention of New Onset Atrial Fibrillation After Transcatheter Aortic Valve Implantation: a Randomized Controlled Trial
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.
- Conditions
- Atrial Fibrillation New Onset
- Being tested
- Amiodarone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmiodaroneDrug
Oral Amiodarone 600mg / day for 6 days before the procedure and then 400mg / day following the implantation of TAVI.
PlaceboDrug
1 tablet of placebo/8 hours 6 days before the procedure and then 1 tablet/12 hours during the 6 days following the implantation of TAVI
| Study group | Role | What they receive |
|---|---|---|
| Amiodarone | Experimental | 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. Receives: Drug: Amiodarone |
| Control | Placebo comparator | 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of new onset atrial fibrillation
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.
Measured: 30 days after transcatheter aortic valve implantation (TAVI)
Secondary outcomes (34)
Incidence of new onset atrial fibrillation
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.
Measured: 60 days after transcatheter aortic valve implantation (TAVI)
Effect of the amiodarone
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.
Measured: 1-year follow-up
Mortality and cardiovascular (CV) mortality.
Compare all-cause mortality and CV mortality between groups.
Measured: 1-year follow-up
Number of patients with major adverse cardiac event (MACE)
MACE: Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate.
Measured: at 30 days after NOAF
Number of patients with MACE
MACE: Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate.
Measured: at 60 days after NOAF
Number of patients with MACE
MACE: Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate.
Measured: at 6 months after NOAF
Number of patients with MACE
MACE: Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate.
Measured: 1-year follow-up
Number of adverse events related to amiodarone
The safety evaluation will be realized by a meticulous vigilance of the adverse effects appeared in the study population.
Measured: at 30 days after NOAF
Number of adverse events related to amiodarone
The safety evaluation will be realized by a meticulous vigilance of the adverse effects appeared in the study population.
Measured: at 60 days after NOAF
Number of adverse events related to amiodarone
The safety evaluation will be realized by a meticulous vigilance of the adverse effects appeared in the study population.
Measured: at 6 months after NOAF
Number of adverse events related to amiodarone
The safety evaluation will be realized by a meticulous vigilance of the adverse effects appeared in the study population.
Measured: 1-year follow-up
Incidence of permanent pacemaker implantation in the both groups.
Need of permanent pacemaker implantation in the both groups.
Measured: at 30 days after NOAF
Incidence of permanent pacemaker implantation in the both groups.
Need of permanent pacemaker implantation in the both groups.
Measured: at 60 days after NOAF
Incidence of permanent pacemaker implantation in the both groups.
Need of permanent pacemaker implantation in the both groups.
Measured: at 6 months after NOAF
Incidence of permanent pacemaker implantation in the both groups.
Need of permanent pacemaker implantation in the both groups.
Measured: 1-year follow-up
Quality of life: EuroQoL 5D
Eq-5D: EuroQoL 5 Dimensions. Score between 0 and 1. The best score 1.
Measured: at 30 days after NOA
Quality of life: Kansas City test
Score between 0 and 100. The best score 100.
Measured: at 30 days after NOA
Quality of life: EuroQoL 5D
Eq-5D: EuroQoL 5 Dimensions. Score between 0 and 1. The best score 1.
Measured: at 60 days after NOAF
Quality of life: Kansas City test
Score between 0 and 100. The best score 100.
Measured: at 60 days after NOAF
Quality of life: EuroQoL 5D
Eq-5D: EuroQoL 5 Dimensions. Score between 0 and 1. The best score 1.
Measured: at 6 months after NOAF
Quality of life: Kansas City test
Score between 0 and 100. The best score 100.
Measured: at 6 months after NOAF
Quality of life: EuroQoL 5D
Eq-5D: EuroQoL 5 Dimensions. Score between 0 and 1. The best score 1.
Measured: 1-year follow-up
Quality of life: Kansas City test
Score between 0 and 100. The best score 100.
Measured: 1-year follow-up
Readmissions due to CV causes
Compare the number of readmissions due to CV causes
Measured: 1-year follow-up
Functional change: New York Heart Association.
Evaluate the functional change according to the NYHA scale. Score between 0 and 4. The best score 1.
Measured: at 30 days after NOA
Functional change: New York Heart Association.
Evaluate the functional change according to the NYHA scale. Score between 0 and 4. The best score 1.
Measured: at 60 days after NOAF
Functional change: New York Heart Association.
Evaluate the functional change according to the NYHA scale. Score between 0 and 4. The best score 1.
Measured: at 6 months after NOAF
Functional change: New York Heart Association.
Evaluate the functional change according to the NYHA scale. Score between 0 and 4. The best score 1.
Measured: 1-year follow-up
Capacity for the exercise
Assess the change in capacity for the exercise, evaluated by the 6-minute walk test between groups
Measured: at 30 days after NOA
Capacity for the exercise
Assess the change in capacity for the exercise, evaluated by the 6-minute walk test between groups
Measured: at 60 days after NOAF
Capacity for the exercise
Assess the change in capacity for the exercise, evaluated by the 6-minute walk test between groups
Measured: at 6 months after NOAF
Capacity for the exercise
Assess the change in capacity for the exercise, evaluated by the 6-minute walk test between groups
Measured: 1-year follow-up
Incidence of Acute renal failure
Compare the number of events due to acute renal failure between groups
Measured: baseline
Incidence of Acute renal failure
Compare the number of events due to acute renal failure between groups
Measured: 30 days after NOA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start30 Jan 2020
- Primary completion9 Oct 2022
- Study completion13 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation New OnsetStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase III Clinical trial, multiple sites, controlled, randomized, double blind, parallel groups.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ana Belen Rivas Paterna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ana Belen Rivas Paterna, Hospital San Carlos, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991754
- Sponsor's protocol ID
- 19/147-R_M
- Acronym
- PAF-TAVI
- Status last verified
- Sep 2026
- First submitted
- 30 May 2019
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Amiodarone for the Prevention of New Onset Atrial Fibrillation After Transcatheter Aortic Valve Implantation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03991754
- Acronym / sponsor ID
- PAF-TAVI / 19/147-R_M
- Conditions
- Atrial Fibrillation New Onset
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Ana Belen Rivas PaternaUniversity, hospital or other
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 9 Oct 2022 (actual)
- Study completion
- 13 Jun 2023 (actual)
- First posted
- 19 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Phase III Clinical trial, multiple sites, controlled, randomized, double blind, parallel groups.
| Arm | Type | Receives |
|---|---|---|
| Amiodarone | Experimental | Drug: AmiodaroneOral 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. |
| Control | Placebo comparator | Drug: PlaceboPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmiodaroneOral Amiodarone 600mg / day for 6 days before the procedure and then 400mg / day following the implantation of TAVI. | Drug | Amiodarone |
| Placebo1 tablet of placebo/8 hours 6 days before the procedure and then 1 tablet/12 hours during the 6 days following the implantation of TAVI | Drug | Control |
Primary outcome
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.
34 secondary outcomes
Incidence of new onset atrial fibrillation
Time frame: 60 days after transcatheter aortic valve implantation (TAVI)
Effect of the amiodarone
Time frame: 1-year follow-up
Mortality and cardiovascular (CV) mortality.
Time frame: 1-year follow-up
Number of patients with major adverse cardiac event (MACE)
Time frame: at 30 days after NOAF
Number of patients with MACE
Time frame: at 60 days after NOAF
Number of patients with MACE
Time frame: at 6 months after NOAF
Number of patients with MACE
Time frame: 1-year follow-up
Number of adverse events related to amiodarone
Time frame: at 30 days after NOAF
Number of adverse events related to amiodarone
Time frame: at 60 days after NOAF
Number of adverse events related to amiodarone
Time frame: at 6 months after NOAF
Number of adverse events related to amiodarone
Time frame: 1-year follow-up
Incidence of permanent pacemaker implantation in the both groups.
Time frame: at 30 days after NOAF
Incidence of permanent pacemaker implantation in the both groups.
Time frame: at 60 days after NOAF
Incidence of permanent pacemaker implantation in the both groups.
Time frame: at 6 months after NOAF
Incidence of permanent pacemaker implantation in the both groups.
Time frame: 1-year follow-up
Quality of life: EuroQoL 5D
Time frame: at 30 days after NOA
Quality of life: Kansas City test
Time frame: at 30 days after NOA
Quality of life: EuroQoL 5D
Time frame: at 60 days after NOAF
Quality of life: Kansas City test
Time frame: at 60 days after NOAF
Quality of life: EuroQoL 5D
Time frame: at 6 months after NOAF
Quality of life: Kansas City test
Time frame: at 6 months after NOAF
Quality of life: EuroQoL 5D
Time frame: 1-year follow-up
Quality of life: Kansas City test
Time frame: 1-year follow-up
Readmissions due to CV causes
Time frame: 1-year follow-up
Functional change: New York Heart Association.
Time frame: at 30 days after NOA
Functional change: New York Heart Association.
Time frame: at 60 days after NOAF
Functional change: New York Heart Association.
Time frame: at 6 months after NOAF
Functional change: New York Heart Association.
Time frame: 1-year follow-up
Capacity for the exercise
Time frame: at 30 days after NOA
Capacity for the exercise
Time frame: at 60 days after NOAF
Capacity for the exercise
Time frame: at 6 months after NOAF
Capacity for the exercise
Time frame: 1-year follow-up
Incidence of Acute renal failure
Time frame: baseline
Incidence of Acute renal failure
Time frame: 30 days after NOA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amiodarone in people with Atrial Fibrillation New Onset, run by Ana Belen Rivas Paterna at 6 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of new onset atrial fibrillation (time frame: 30 days after transcatheter aortic valve implantation (TAVI)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.